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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)

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.

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.

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