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MammoScreen® 4 is a concurrent reading and reporting aid for physicians interpreting screening mammograms. It is intended for use with compatible full-field digital mammography and digital breast tomosynthesis systems. The device can also use compatible prior examinations in the analysis.

Output of the device includes graphical marks of findings as soft-tissue lesions or calcifications on mammograms along with their level of suspicion scores. The lesion type is characterized as mass/asymmetry, distortion, or calcifications for each detected finding. The level of suspicion score is expressed at the finding level, for each breast, and overall for the mammogram.

The location of findings, including quadrant, depth, and distance from the nipple, is also provided. This adjunctive information is intended to assist interpreting physicians during reporting.

Patient management decisions should not be made solely based on the analysis by MammoScreen 4.

MammoScreen 4 is a concurrent reading medical software device using artificial intelligence to assist radiologists in the interpretation of mammograms.

MammoScreen 4 processes the mammogram(s) and detects findings suspicious for breast cancer. Each detected finding gets a score called the MammoScreen Score™. The score was designed such that findings with a low score have a very low level of suspicion. As the score increases, so does the level of suspicion. For each mammogram, MammoScreen 4 outputs the detected findings with their associated score, a score per breast, driven by the highest finding score for each breast, and a score per case, driven by the highest finding score overall. The MammoScreen Score goes from one to ten.

MammoScreen 4 is available for 2D (FFDM images) and 3D processing (FFDM & DBT or 2DSM & DBT). Optionally, MammoScreen 4 can use prior examinations in the analysis.

The results indicating potential breast cancer, identified by MammoScreen 4, are accessible via a dedicated user interface and can seamlessly integrate into DICOM viewers (using DICOM-SC and DICOM-SR). Reporting aid outputs can be incorporated into the practice's reporting system to generate a preliminary report.

Note that the MammoScreen 4 outputs should be used as complementary information by radiologists while interpreting mammograms. For all cases, the medical professional interpreting the mammogram remains the sole decision-maker.

The provided text describes the acceptance criteria and a study to prove that MammoScreen® 4 meets these criteria. Here is a breakdown of the requested information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Rationale for using "MammoScreen 2" data for comparison: The document states that the standalone testing for MammoScreen 4 compared its performance against "MammoScreen 2 on Dimension". While MammoScreen 3 is the predicate device, the provided performance data in the standalone test section specifically refers to MammoScreen 2. The PCCP section later references performance targets for MammoScreen versions 1, 2, and 3, but the actual "Primary endpoint" results for the current device validation are given in comparison to MammoScreen 2. Therefore, the table below uses the reported performance against MammoScreen 2 as per the "Primary endpoint" section.

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