The Affirm breast biopsy guidance system is an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

Device Description

The Affirm Breast Biopsy Guidance System used with the Selenia Dimensions 2D Full Field Digital Mammography System (FFDM), is a stereotactic lesion localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.

Stereotactic images on the host mammography system are acquired at +/-15°. The stereo images are calculated with Cartesian coordinates to target lesions. Stereo images are displayed on the mammography system display for the targeting procedure. Images are then sent to PACS for archiving via DICOM protocol.

Safety Features include:

Automatic detection of mounting, latching, and connection of biopsy module
C-arm motion disabled if biopsy module is not locked in place
Automatic compression release disabled when biopsy module installed
Motorized movement of biopsy device only under user control
Audible alert if biopsy device motion could result in mechanical interference

AI/ML Overview

The provided document, a 510(k) summary for the Hologic Affirm Breast Biopsy Guidance System, does not contain the detailed information necessary to fully describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.

Specifically, it lacks:

A table of acceptance criteria and reported device performance.
Sample sizes for a test set, its provenance, or how ground truth was established for it.
Details on the number or qualifications of experts for ground truth establishment.
Adjudication methods.
Information on any multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
Information on a standalone performance study.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set or how ground truth for the training set was established.

Based on the provided text, the available information is as follows:

1. A table of acceptance criteria and the reported device performance:

The document states that "The Hologic Affirm Breast Biopsy Guidance System was successfully tested by UL to IEC 60601-1 Medical Electrical Equipment Standards" and "Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820."
It does not provide specific acceptance criteria or quantitative performance metrics in a table format for a clinical or performance study of the guidance system's accuracy in localizing lesions, which would typically be relevant for a device like this. The "performance" mentioned is with respect to safety and regulatory compliance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The document describes the device as a "stereotactic lesion localization system" and a "guidance system for interventional purposes." It does not mention any MRMC study comparing human reader performance with or without AI assistance, nor does it provide an effect size.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document does not explicitly describe a standalone performance study in the context of lesion localization accuracy. The "Summary of Testing" focuses on compliance with electrical safety standards and design control verification/validation, not clinical performance metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document.

8. The sample size for the training set:
This information is not provided in the document.

9. How the ground truth for the training set was established:
This information is not provided in the document.

Summary of available information regarding the study:

Study Purpose: To demonstrate substantial equivalence to the predicate device (Hologic Digital StereoLoc II) and perform safety and design control verification/validation.
Safety Testing: Successfully tested by UL to IEC 60601-1 Medical Electrical Equipment Standards for electrical and mechanical safety.
Regulatory Compliance: Conforms with ACR/NEMA Digital Imaging Communications in Medicine version 3.0 for image capture, saving, and transmission. Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820.
Conclusion: The device's design, operation, construction, and materials are similar to existing marketed devices with no additional risks or hazards, supporting its substantial equivalence determination.

The document primarily focuses on regulatory compliance, safety, and substantial equivalence to a predicate device, rather than detailed clinical performance studies with specific acceptance criteria and outcome metrics that would typically be associated with AI or advanced diagnostic devices.

Summary

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Hologic, Inc.

Affirm Breast Biopsy Guidance System Special 510(k) Premarket Notification

KI03212

510(k) Summarv

JAN 7 - 2011

This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87 (b)

Product Name: Affirm Breast Biopsy Guidance System

Product Classification Name: Mammographic X-Ray System

Product Classification Code: 90 IZH CFR Section: 892.1710

Classification Panel: Radiology

Class

Manufacturer:

Hologic, Inc. 36-37 Apple Ridge Road Danbury, CT 06810 USA

Contact Person:	Gail Yaeker-Daunis
Telephone Number:	(203) 731-8337
Fax Number:	(203) 731-8440

November 28, 2010 Date Prepared:

Predicate Device: K071542, Hologic Digital StereoLoc II

Device Description:

Safety Features include:

Automatic detection of mounting, latching, and connection of biopsy module

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C-arm motion disabled if biopsy module is not locked in place
Automatic compression release disabled when biopsy module installed
Motorized movement of biopsy device only under user control
Audible alert if biopsy device motion could result in mechanical interference

Indications for Use:

The Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

Comparison with Predicate Devices:

The Hologic Affirm Breast Biopsy Guidance System is substantially equivalent to K071542 Hologic Digital StereoLoc II, which is used with the Selenia Full Field Digital Mammography X-ray system to provide location of areas of concern and pre-surgical localization for performance of breast biopsies on an upright mammography system.

Summary of Testing

The Hologic Affirm Breast Biopsy Guidance System was successfully tested by UL to IEC 60601-1 Medical Electrical Equipment Standards. Stereotactic images captured, saved and/or transmitted by the Selenia Dimensions 2D FFDM conform with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.

Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820.

Conclusion

The Affirm Breast Biopsy Guidance System design, operation, construction and materials are similar to existing marketed device with no additional risks or hazards.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JAN 7 2011

Ms. Gail Yaeker-Daunis Senior Regulatory Specialist Hologic, Inc. 36-37 Apple Ridge Road DANBURY CT 06810

Re: K103512

Trade/Device Name: Affirm Breast Biopsy Guidance System Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: IZH Dated: November 29, 2010 Received: November 30, 2010

Dear Ms. Yaeker-Daunis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Hologic, Inc.

Affirm Breast Biopsy Guidance System Special 510(k) Premarket Notification

Indications for Use

Premarket Notification: Affirm Breast Biopsy Guidance System

KID3512 510(k) No.

Device Name: Affirm Breast Biopsy Guidance System

Indications For Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use : AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K103512

015

Pg 1 of

Regulation Number and Section

§ 892.1710 Mammographic x-ray system.

(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.