The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVueâ„¢ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This includes obtaining information that can be used to properly plan, design, and power future ROC reader studies. This reader study will include a minimum of 6 radiologist readers and an enriched sample of at least 100 breast screening or diagnostic cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839). The reader study image case set will be enriched with cancer cases.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
MRMC Analysis: ROC AUC
Timeframe: 8 Weeks