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MammoScreen® 3 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 3.

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

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

MammoScreen can also aid in the reporting process by populating an initial report with chosen findings, including lesion type and position (quadrant, depth and distance to nipple).

The results indicating potential breast cancer, identified by MammoScreen, 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. Additionally, certain outputs like the case score can be reported into the patient management worklist.

Note that the MammoScreen 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.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table within the document. However, the clinical and standalone performance studies establish benchmarks and demonstrate achievement of certain levels of accuracy, sensitivity, and specificity. The criteria are implied through the statement "MammoScreen 3 achieved superior performance compared to the predicate device" and the detailed statistical results provided.

Table of Performance Results

Given that specific "acceptance criteria" (e.g., "AUROC must be > X") are not explicitly stated, I will present the reported performance of MammoScreen 3 in both co-reading and standalone modes, along with improvements (effect sizes) in the co-reading scenario.

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