Mammography Prior Enhancement (MPE) is a software application intended to enhance the appearance of prior non-Hologic digital mammography x-ray images so that they more closely resemble Hologic digital mammography images. MPE processed images are intended for comparison purposes only and cannot be used for primary diagnosis.

MPE runs on a Windows-based computer. Results can be displayed on a workstation capable of displaying mammography x-ray images, such as Hologic's SecurView® DX workstation, Product Code LLZ, CFR 892.2050 (K103385)

Device Description

MPE is a software application that runs on a Windows server or softcopy display workstation, such as SecurView DX (K103385). MPE processes (manipulates) prior GE digital mammography images so that they will appear similar to Hologic digital mammography images. The image processing consists of various steps to improve visualization of structures in the breast including, logarithmic conversion, skin line correction and contrast enhancement. These are standard methods used to allow optimal display and review of mammography images with minimal window/leveling operation.

AI/ML Overview

The provided text describes a 510(k) submission for the Mammography Prior Enhancement (MPE) device and its substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or a specific study that proves the device meets those criteria in a quantitative manner.

Here's a breakdown of the information available and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided text in a quantitative or measurable format. The document focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and safety/effectiveness concerns addressed by adherence to standards and risk management.
Reported Device Performance: The text states, "The MPE software further processes and displays prior digital mammography images for physicians or trained medical personnel to use as a historical image reference when reviewing current Hologic digital mammography images. The MPE processed images will appear similar to Hologic digital images." This is a qualitative description of its function but lacks specific performance metrics (e.g., image quality scores, similarity metrics).

2. Sample Size Used for the Test Set and Data Provenance:

Not provided. The document does not mention any specific test set size, data provenance (country of origin), or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not provided. There is no mention of experts, ground truth establishment, or their qualifications.

4. Adjudication Method for the Test Set:

Not applicable/Not provided. Since no specific test set or ground truth establishment method is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

Not performed or reported. The 510(k) summary does not describe any MRMC study comparing human reader performance with and without AI assistance. The focus is on image processing for comparison, not diagnostic performance improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not performed or reported as a performance study. The device's function is standalone in the sense that it processes images automatically. However, there's no standalone performance study reported with specific metrics. Its output is explicitly stated as "for comparison purposes only and cannot be used for primary diagnosis," which inherently avoids standalone diagnostic performance claims.

7. The Type of Ground Truth Used:

Not applicable/Not provided. As no performance study with a defined ground truth is described, this information is not present.

8. The Sample Size for the Training Set:

Not provided. There is no mention of a training set or its size.

9. How the Ground Truth for the Training Set was Established:

Not applicable/Not provided. Since no training set or ground truth establishment is described, this information is not present.

Summary of available information related to "acceptance criteria" and "study":

The "study" or justification for the device's acceptance presented in this 510(k) is primarily based on:

Demonstration of Substantial Equivalence: The MPE software shares the same intended use, technological characteristics, and performance standards as its predicate device (DigitalNow HD, K091368).
Adherence to Standards: The device is designed and manufactured according to ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820.
Risk Management: Potential hazards are controlled via risk management processes and verification and validation testing, ensuring "no risk of data loss" and that "MPE processed images are not intended for diagnosis."
Intended Use Limitations: The key acceptance criterion implicitly stated is that the processed images are "for comparison purposes only and cannot be used for primary diagnosis."

The document focuses on regulatory compliance and safe operation within its limited intended use, rather than a quantitative clinical performance study with specific acceptance metrics. For a device intended "for comparison purposes only" and not for primary diagnosis, a full clinical performance study as might be expected for an AI diagnostic aid is often not required for 510(k) clearance, as the primary risk is misuse (i.e., using it for diagnosis), which is mitigated by labeling and intended use restrictions.

Summary

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Hologic, Inc.

510(k) MPE

510(k) Summary

Product Name:	Mammography Prior Enhancement (MPE) DEC 20 2012
Product Classification Name:	Picture archiving and communication system
Product Classification Code:	LLZ CFR Section: 892.2050
Classification Panel:	Radiology Class II
Manufacturer:	Hologic, Inc.35 Crosby DriveBedford, MA 01730 USA
Contact Person:	Gail Yaeker-DaunisTelephone Number: (203) 731-8337Fax Number: (203) 731-8440
Date Prepared:	November 13, 2012
Predicate Device:	Digital Now HD K091368

Predicate Device Description:

The Digital Now HD, K091368, is a software application intended to process digitized screen film mammography images for comparison purposes only. The software processes digitized prior film images to produce lossy-compressed DICOM images that more closely resemble digital mammography images. The R2 DigitalNow HD images are intended for comparison purposes only and cannot be used for primary diagnosis. The DigitalNow HD is a software application which runs on the Hologic Cenova server. (Class I exempt per 21 CFR § 892.2010 and CFR § 892.2020).

Device Description:

Intended Use:

Mammography Prior Enhancement (MPE) is a software application intended to enhance the appearance of prior non-Hologic digital mammography x-ray images so that they more

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closely resemble Hologic digital mammography images. MPE processed images are intended for comparison purposes only and cannot be used for primary diagnosis.

Comparison with Predicate Device:

The MPE software application is similar to DigitalNow HD cleared as K091368. Both devices are software sharing the same technological characteristics. MPE and Digital-Now HD are both used to further process mammography images for use as reference during prior to current mammography image comparisons.

Technological Characteristics:

The device is software application and does not contact the patient, a diagnosis is not made from the MPE processed image, nor does it control any life-sustaining devices.

Safety and Effectiveness Concerns:

MPE is designed and manufactured in accordance with the following standards:

. ISO 13845 Medical Devices - Quality management Systems
. ISO 14971 Medical Devices - Application of Risk Management -
. IEC 62304 Medical Device Software Life Cycle Process
21 CFR Part 820 Quality System Regulations .

The performance of the software is tested in accordance with Hologic's design control procedures to demonstrate intended performance. Potential hazards are controlled via risk management processes and verification and validation testing. Instructions for use are provided to facilitate intended operation.

Conclusion:

The MPE software further processes and displays prior digital mammography images for physicians or trained medical personnel to use as a historical image reference when reviewing current Hologic digital mammography images. The MPE processed images will appear similar to Hologic digital images.

The MPE software application and the predicate device share the same intended use, technical characteristic and performance standards. Potential hazards have been studied and controlled by a Risk Management Plan. Device failures which might result in partial or failed images do not affect the original saved image so there is no risk of data loss. MPE processed images are not intended for diagnosis. Based on the information supplied in this 510(k), the MPE software application is safe, effective and is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 20, 2012

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

Re: K123530

Trade/Device Name: Mammography Prior Enhancement Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 15, 2012 Received: November 26, 2012

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 to 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Yaeker-Daunis

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you aconto oper fida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris -S

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123530

Device Name: Mammography Prior Enhancement

Indications for Use:

Mammography Prior Enhancement (MPE) is a software application intended to enhance the appearance of prior non-Hologic digital mammography x-ray images so that they more closely resemble Hologic digital mammography images. MPE-processed images are intended for comparison purposes only and cannot be used for primary diagnosis.

MPE runs on a Windows-based computer. Results can be displayed on a workstation capable of displaying mammography x-ray images, such as Hologic's SecurView® DX workstation.

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

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Janine MN Morris -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K123530

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Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).