Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What does the classification regulation designate this guidance document as?	the special control
What does the firm need to show that its device addresses the issues of safety and effectiveness identified in this guidance?	The firm will need to show that its device addresses the issues of safety and effectiveness
What are biomarker tests that rely on biological imaging assessments called?	MRI
What must a manufacturer do to ensure the safety and effectiveness of full-field digital mammography devices?	conform to the general controls of the FD&C Act, including the premarket notification requirements
What is the 21 CFR 807 Subpart E of the 21 CFR 807 Subpart E of the 21 CFR 807 Subpart E of the 21 CFR 807.81?	21 CFR 807.87
What is the scope of this document limited to?	FFDM systems
What is a full-field digital mammography system intended to produce?	planar digital x-ray images of the entire breast
What is the FDA guidance document entitled?	Class II Special Controls Guidance Document: Full-Field Digital Mammography System
What is the acquisition work station used for?	acquisition work station
What is the detector readout device?	removable solid state detector
What is the class of devices that display accessories to an FFDM System?	class II
What should you identify your device by in a 510(k) premarket notification?	regulation and product code
What is the (device name) intended to be used in the same clinical applica?	The (device name)
What may require longer periods of time to evaluate?	clinically meaningful outcomes
What is the screening use of an FFDM system?	An FFDM system can be indicated for screening use only or for both screening and diagnostic uses
What is the amorphous silicon with deposit of cesium iodide?	cesium iodide
What is the size of active area?	pixel dimensions and fill factor
What is the flat-field correction procedure called?	the flat-field correction procedure
What is the ADC?	bit depth, matrix size, and pixel width
What is SID?	source to patient support device distance
What should you describe for the x-ray tube if manufactured by a third party?	trade name and model
What is the AEC detector used for?	low level pre-exposure
What is acceptable if an alternative method is chosen?	it should be described completely
What should describe the paddle types, sizes, geometries, and materials?	breast compression system
What should be well established evidence and agreement in the clinical community that the chosen biomarker test reflects a characteristic that is important to 6 the underlying disease process and that it is associated with a?	the chosen biomarker test
What is the level of concern?	the risks associated with software failure
What is the replacement for film cassettes for detectors intended to be used with conventional mammographic x-ray systems?	computed radiography (CR) plate/reader/display systems
What is the radiation dose a function of?	breast thickness and composition
What measures are described in this guidance document?	measures recommended to mitigate these identified risks
What is the name of the standard that should be used to evaluate the electrical safety of your device?	Clinical Image Evaluation 8. Physical Laboratory Testing Inadequate breast coverage 9. Clinical Image Evaluation Excessive x-ray exposure 8. Physical Laboratory Testing Inappropriate breast compression 8. Physical Laboratory Testing 7. Biocompatibility Testing Infection, skin irritation 10. Labeling 6. Electrical Safety You should evaluate the electrical safety of your device according to the following standards or use equivalent me Answer:
What is the Collateral standard?	Safety requirements for medical electrical systems
What should you assess in your physical laboratory?	imaging characteristics of your system
What should you describe as general guidance for these tests?	all phantoms
What is a phantom?	Mammography Accreditation Program (MAP) phantom
What should be performed under conditions that match the intended clinical use of the system?	testing
What is the system code NFJ?	System, Image Management, Ophthalmic
What is the MDDT program?	The FDA’s Medical Device Development Tools
What should you report if you were to assess imaging performance?	the trade name, characteristics
What should you provide quantitative data on?	sensitometric response
What is the NPS?	noise power spectrum
What is the measure of the efficiency of signal-to-noise ratio?	SNR
What is the exposure level chosen from those used in clinical practice called?	the “reference” level
What should you provide a quantitative measure of?	dynamic range
What is a function of the number of erasures and exposures?	tests of image retention
What should you provide results of with 100 or more repeated exposures and erasures showing that there are no residual or ghost images?	null
What should you provide results of with 100 or more repeated exposures and erasures showing that there are no residual or ghost images?	Repeated Exposure Test
What should you provide to evaluate AEC performance?	data sets for a range of thicknesses from 2 to 6 cm of a homogeneous material at standard mode and magnification mode if available
What should be provided for imaging of the ACR MAP phantom and for the wax target plate of the phantom?	null
What should clinical outcome assessments consist of?	direct quantitative measurement of the effect of a treatment upon disease progression and its impact upon the patient
What should be included in the results of the AEC system if it has more than one mode of operation?	Exposure conditions and dose
What is a C-D diagram?	a plot of the minimum detectable target thickness or contrast as a function of target size
What is the k factor not greater than?	80 m2
What is the minimum exposure level for FFDM devices?	21 CFR 892.1950
What should your testing simulate?	2, 4.2, and 6 cm thick compressed breasts
What is the resulting patient radiation dose?	exposure level at the entrance surface of the phantom along with the resulting patient radiation dose
What is the minimum and maximum powered compression?	Breast Compression System
What is the purpose of this evaluation?	to determine if the FFDM images, when reviewed by expert radiologists, are judged to be of sufficiently acceptable quality for mammographic usage that they are substantially equivalent in safety and effecti
What is the new device substantially equivalent in safety and effectiveness to?	laboratory performance of the predicate device
What are the names of the craniocaudal and mediolateral oblique views?	craniocaudal (CC) and mediolateral oblique (MLO) views
What should be considered when developing clinical effectiveness endpoints?	The patient population, the nature of the underlying condition, and how they will be studied over time
How many expert mammographic radiologists should review clinical images submitted for MQSA accreditation?	two
What is the verall assessment of whether these image sets collectively are of sufficiently acceptable quality for use in clinical mammography and to allow determination of substantial equivalence to a predicate device?	breast positioning
What should the associated information include for each image?	compressed breast thickness, x-ray exposure conditions (anode, filter, kVp, mAs, exposure, half-value layer), and estimated dose
What should be fully explained by the expert mammographic radiologists?	mammography quality control manual
What must labeling satisfy?	21 CFR 807.87(e)
What should be discussed with the precautions regarding the potential for adverse events associated with the use of the device and mitigation measures?	The adverse events should include: • excessive breast compression; • excessive x-ray exposure; • electric shock; • infection; and • skin irritation, abrasions or puncture wounds
What should you list for detector-only systems?	the x-ray system specifications and performance requirements
What is the purpose of the ation dose?	to be used to verify proper AEC performance
What should you include a summary of?	sensitometric response
What is the patient population used for?	age, ethnic origin
What should labeling of the device be consistent with?	manner in which it was studied
What should be encouraged in the instructions?	local/institutional training programs
What is the AEC?	Automatic Exposure Control
How long have you been practicing radiology since residency?	at least five years
What is the name of the department that evaluates Cardiovascular Devices?	Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Cardiovascular Devices Cardiac Electrophysiology and Monitoring Branch 1 Preface Public Comment: What is the name of the department that evaluates Cardiovascular Devices
Where can you submit electronic comments for Agency consideration?	Division of Dockets Management, Food and Drug Administration
Where can you get ional copies of the guidance?	the Internet
What does not apply to electrodes or dispersive pads used for defibrillation, pacing, or cardioversion?	This guidance
What does this guidance document describe?	a means by which ECG electrodes may comply with the requirement of class II special controls (513(a)(1)(B) of the act
What must a manufacturer submit to provide equivalent assurances of safety and effectiveness?	a 510(k)
What must a class II device comply with as a class II device?	general and special controls
What is a disease-altering benefit?	treatment of the underlying disease or condition
What does FDA recommend that manufacturers document how they address the recommendations in their design history file?	how they address the recommendations in this special controls guidance
Who does not need to submit a 510(k) to FDA and receive agency clearance prior to marketing a device of this type?	persons who intend to market a device of this type
What is the scope of this document limited to?	ECG electrodes
What are generally used to deliver a small amount of alternating current with a high frequency?	Bioimpedance electrodes
What is the scope of electrodes used for?	external pacing or other treatment effect
What is the FDA recommend to mitigate the risks identified in this guidance document?	5 Recommended mitigation measures Identified risk Adverse tissue reactions to the skin-contacting Section 5. Performance Characteristics electrode materials Section 6. Labeling Section 5. Performance Characteristics Misdiagnosis Section 6. Labeling Section 5. Performance Characteristics Electrical shock 21 CFR 898 P Answer: FDA has identified the following risks to health associated with the use of the ECG electrode.
What must you maintain for each type of device?	device specifications, including appropriate drawings
What should be included in the cription?	a listing of all features and specifications of the device (a tabular format is desirable)
What is the 21 CFR 820.20?	Quality Systems Requirements
What is the type of electrodes?	bare
What is the FDA's recommendation for early engagement with CDRH?	to obtain more detailed feedback
What should not cause an irritating, sensitizing or cytotoxic effect upon the skin?	null
What should not allow irritating sensitizing, or cytotoxic materials to enter the skin by iontophoresis?	electrodes
What is the electrolytic composition of some electroconductive gels that contain high levels of saline?	saline
What should the design of the electrode ensure?	it will adhere to the patient’s skin for the duration of use compatible with the intended use of the device
What do you test if the electrode is intended to be used on a diaphoretic patient or during strenuous exercise?	adhesive performance
What should monitor the critical parameters of your final finished disposable ECG electrode to assure adequate device performance during its entire shelf-life?	Stability studies
What should be supported and validated by real-time shelf life testing?	accelerated shelf life testing

What does the classification regulation designate this guidance document as?

the special control

What does the firm need to show that its device addresses the issues of safety and effectiveness identified in this guidance?

The firm will need to show that its device addresses the issues of safety and effectiveness

What are biomarker tests that rely on biological imaging assessments called?

MRI

What must a manufacturer do to ensure the safety and effectiveness of full-field digital mammography devices?

conform to the general controls of the FD&C Act, including the premarket notification requirements

What is the 21 CFR 807 Subpart E of the 21 CFR 807 Subpart E of the 21 CFR 807 Subpart E of the 21 CFR 807.81?

21 CFR 807.87

What is the scope of this document limited to?

FFDM systems

What is a full-field digital mammography system intended to produce?

planar digital x-ray images of the entire breast

What is the FDA guidance document entitled?

Class II Special Controls Guidance Document: Full-Field Digital Mammography System

What is the acquisition work station used for?

acquisition work station

What is the detector readout device?

removable solid state detector

What is the class of devices that display accessories to an FFDM System?

class II

What should you identify your device by in a 510(k) premarket notification?

regulation and product code

What is the (device name) intended to be used in the same clinical applica?

The (device name)

What may require longer periods of time to evaluate?

clinically meaningful outcomes

What is the screening use of an FFDM system?

An FFDM system can be indicated for screening use only or for both screening and diagnostic uses

What is the amorphous silicon with deposit of cesium iodide?

cesium iodide

What is the size of active area?

pixel dimensions and fill factor

What is the flat-field correction procedure called?

the flat-field correction procedure

What is the ADC?

bit depth, matrix size, and pixel width

What is SID?

source to patient support device distance

What should you describe for the x-ray tube if manufactured by a third party?

trade name and model

What is the AEC detector used for?

low level pre-exposure

What is acceptable if an alternative method is chosen?

it should be described completely

What should describe the paddle types, sizes, geometries, and materials?

breast compression system

What should be well established evidence and agreement in the clinical community that the chosen biomarker test reflects a characteristic that is important to 6 the underlying disease process and that it is associated with a?

the chosen biomarker test

What is the level of concern?

the risks associated with software failure

What is the replacement for film cassettes for detectors intended to be used with conventional mammographic x-ray systems?

computed radiography (CR) plate/reader/display systems

What is the radiation dose a function of?

breast thickness and composition

What measures are described in this guidance document?

measures recommended to mitigate these identified risks

What is the name of the standard that should be used to evaluate the electrical safety of your device?

Clinical Image Evaluation 8. Physical Laboratory Testing Inadequate breast coverage 9. Clinical Image Evaluation Excessive x-ray exposure 8. Physical Laboratory Testing Inappropriate breast compression 8. Physical Laboratory Testing 7. Biocompatibility Testing Infection, skin irritation 10. Labeling 6. Electrical Safety You should evaluate the electrical safety of your device according to the following standards or use equivalent me Answer:

What is the Collateral standard?

Safety requirements for medical electrical systems

What should you assess in your physical laboratory?

imaging characteristics of your system

What should you describe as general guidance for these tests?

all phantoms

What is a phantom?

Mammography Accreditation Program (MAP) phantom

What should be performed under conditions that match the intended clinical use of the system?

testing

What is the system code NFJ?

System, Image Management, Ophthalmic

What is the MDDT program?

The FDA’s Medical Device Development Tools

What should you report if you were to assess imaging performance?

the trade name, characteristics

What should you provide quantitative data on?

sensitometric response

What is the NPS?

noise power spectrum

What is the measure of the efficiency of signal-to-noise ratio?

SNR

What is the exposure level chosen from those used in clinical practice called?

the “reference” level

What should you provide a quantitative measure of?

dynamic range

What is a function of the number of erasures and exposures?

tests of image retention

What should you provide results of with 100 or more repeated exposures and erasures showing that there are no residual or ghost images?

null

What should you provide results of with 100 or more repeated exposures and erasures showing that there are no residual or ghost images?

Repeated Exposure Test

What should you provide to evaluate AEC performance?

data sets for a range of thicknesses from 2 to 6 cm of a homogeneous material at standard mode and magnification mode if available

What should be provided for imaging of the ACR MAP phantom and for the wax target plate of the phantom?

null

What should clinical outcome assessments consist of?

direct quantitative measurement of the effect of a treatment upon disease progression and its impact upon the patient

What should be included in the results of the AEC system if it has more than one mode of operation?

Exposure conditions and dose

What is a C-D diagram?

a plot of the minimum detectable target thickness or contrast as a function of target size

What is the k factor not greater than?

80 m2

What is the minimum exposure level for FFDM devices?

21 CFR 892.1950

What should your testing simulate?

2, 4.2, and 6 cm thick compressed breasts

What is the resulting patient radiation dose?

exposure level at the entrance surface of the phantom along with the resulting patient radiation dose

What is the minimum and maximum powered compression?

Breast Compression System

What is the purpose of this evaluation?

to determine if the FFDM images, when reviewed by expert radiologists, are judged to be of sufficiently acceptable quality for mammographic usage that they are substantially equivalent in safety and effecti

What is the new device substantially equivalent in safety and effectiveness to?

laboratory performance of the predicate device

What are the names of the craniocaudal and mediolateral oblique views?

craniocaudal (CC) and mediolateral oblique (MLO) views

What should be considered when developing clinical effectiveness endpoints?

The patient population, the nature of the underlying condition, and how they will be studied over time

How many expert mammographic radiologists should review clinical images submitted for MQSA accreditation?

two

What is the verall assessment of whether these image sets collectively are of sufficiently acceptable quality for use in clinical mammography and to allow determination of substantial equivalence to a predicate device?

breast positioning

What should the associated information include for each image?

compressed breast thickness, x-ray exposure conditions (anode, filter, kVp, mAs, exposure, half-value layer), and estimated dose

What should be fully explained by the expert mammographic radiologists?

mammography quality control manual

What must labeling satisfy?

21 CFR 807.87(e)

What should be discussed with the precautions regarding the potential for adverse events associated with the use of the device and mitigation measures?

The adverse events should include: • excessive breast compression; • excessive x-ray exposure; • electric shock; • infection; and • skin irritation, abrasions or puncture wounds

What should you list for detector-only systems?

the x-ray system specifications and performance requirements

What is the purpose of the ation dose?

to be used to verify proper AEC performance

What should you include a summary of?

sensitometric response

What is the patient population used for?

age, ethnic origin

What should labeling of the device be consistent with?

manner in which it was studied

What should be encouraged in the instructions?

local/institutional training programs

What is the AEC?

Automatic Exposure Control

How long have you been practicing radiology since residency?

at least five years

What is the name of the department that evaluates Cardiovascular Devices?

Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Cardiovascular Devices Cardiac Electrophysiology and Monitoring Branch 1 Preface Public Comment: What is the name of the department that evaluates Cardiovascular Devices

Where can you submit electronic comments for Agency consideration?

Division of Dockets Management, Food and Drug Administration

Where can you get ional copies of the guidance?

the Internet

What does not apply to electrodes or dispersive pads used for defibrillation, pacing, or cardioversion?

This guidance

What does this guidance document describe?

a means by which ECG electrodes may comply with the requirement of class II special controls (513(a)(1)(B) of the act

What must a manufacturer submit to provide equivalent assurances of safety and effectiveness?

a 510(k)

What must a class II device comply with as a class II device?

general and special controls

What is a disease-altering benefit?

treatment of the underlying disease or condition

What does FDA recommend that manufacturers document how they address the recommendations in their design history file?

how they address the recommendations in this special controls guidance

Who does not need to submit a 510(k) to FDA and receive agency clearance prior to marketing a device of this type?

persons who intend to market a device of this type

What is the scope of this document limited to?

ECG electrodes

What are generally used to deliver a small amount of alternating current with a high frequency?

Bioimpedance electrodes

What is the scope of electrodes used for?

external pacing or other treatment effect

What is the FDA recommend to mitigate the risks identified in this guidance document?

5 Recommended mitigation measures Identified risk Adverse tissue reactions to the skin-contacting Section 5. Performance Characteristics electrode materials Section 6. Labeling Section 5. Performance Characteristics Misdiagnosis Section 6. Labeling Section 5. Performance Characteristics Electrical shock 21 CFR 898 P Answer: FDA has identified the following risks to health associated with the use of the ECG electrode.

What must you maintain for each type of device?

device specifications, including appropriate drawings

What should be included in the cription?

a listing of all features and specifications of the device (a tabular format is desirable)

What is the 21 CFR 820.20?

Quality Systems Requirements

What is the type of electrodes?

bare

What is the FDA's recommendation for early engagement with CDRH?

to obtain more detailed feedback

What should not cause an irritating, sensitizing or cytotoxic effect upon the skin?

null

What should not allow irritating sensitizing, or cytotoxic materials to enter the skin by iontophoresis?

electrodes

What is the electrolytic composition of some electroconductive gels that contain high levels of saline?

saline

What should the design of the electrode ensure?

it will adhere to the patient’s skin for the duration of use compatible with the intended use of the device

What do you test if the electrode is intended to be used on a diaphoretic patient or during strenuous exercise?

adhesive performance

What should monitor the critical parameters of your final finished disposable ECG electrode to assure adequate device performance during its entire shelf-life?

Stability studies

What should be supported and validated by real-time shelf life testing?

accelerated shelf life testing