MammoScreen
TherapixelMammoScreen is an AI-based software that assists physicians in interpreting full-field digital mammograms (FFDM) by identifying suspicious breast lesions such as soft tissue lesions and calcifications. It provides marks on the mammogram images alongside a suspicion score to help detect potential breast cancer, supporting radiologists during their reading process to improve cancer detection without replacing clinical judgment.
Intended Use
MammoScreen is intended for use as a concurrent reading aid for interpreting physicians, to help identify findings on screening FFDM acquired with compatible mammography systems and assess their level of suspicion.
Technology
MammoScreen comprises a software-only system with machine learning algorithms, including deep learning modules trained on large biopsy-proven datasets to detect suspicious calcifications and soft tissue lesions. It operates as a DICOM Web compliant node, processing FFDM images from mammography systems, and provides output as marks and a suspicion score on a 1-10 scale via a user interface.
Performance
Clinical and non-clinical testing show MammoScreen is safe and effective. A clinical multi-reader multi-case study with 14 radiologists and 240 mammograms demonstrated improved radiologist performance with MammoScreen (AUC increased from 0.77 to 0.80, p=0.035), with significant improvement at breast and lesion levels. Standalone performance was comparable to radiologists. Non-clinical testing included software verification, beta validation, and hazard analysis.
Predicate Devices
No predicate devices specified
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