Saige-Density
DeepHealth, Inc.Saige-Density is a medical software that uses AI deep learning techniques to analyze digital mammograms, producing breast density categories based on ACR BI-RADS guidelines. It helps radiologists assess breast tissue composition by providing adjunctive information, improving breast cancer risk assessment and screening interpretation.
Intended Use
Saige-Density is a software application intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. Saige-Density provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Saige-Density produces adjunctive information. It is not a diagnostic aid.
Technology
Saige-Density is a Software as a Medical Device that processes screening and diagnostic digital mammograms using deep learning techniques. It inputs 2D DICOM images (FFDM and/or 2D synthetics), producing a study-level breast density category. Outputs are DICOM structured report and secondary capture objects containing the breast density category following BI-RADS guidelines.
Performance
Validation was performed via a multi-site retrospective study on 796 mammogram cases (6,170 images) from five U.S. breast imaging centers distinct from training sites. Accuracy in four-class breast density categorization was 81.28%, with robust statistical analysis by an independent biostatistician.
Predicate Devices
No predicate devices specified
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