DenSeeMammo is a software tool designed to assist radiologists by automatically estimating breast density from digital mammography images. It analyzes 2D mammograms and categorizes breast density according to the BI-RADS 5th Edition, providing additional information to aid breast cancer risk assessment. The final breast density assessment remains the responsibility of the qualified physician. This helps clinicians make consistent and informed evaluations of breast density, potentially improving screening and diagnosis.
Intended Use
DenSeeMammo is a software application intended for use with Full Field Digital Mammography systems. It estimates BI-RADS breast density category by analyzing processed digital 2D mammograms using a fully automated comparison procedure. DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density. It produces adjunctive information but is not a diagnostic aid as the final assessment is made by a qualified physician.
Technology
The software uses proprietary algorithms to compare processed digital 2D mammograms against qualified databases of images visually assessed by radiologists. It operates in a client-server mode requiring a local network connection and is developed as a web application with a graphical user interface displayed via a web browser. It supports images from GE Senographe Essentials and Hologic Selenia Dimension mammography systems.
Performance
Verification and validation testing included unit and system-level tests, reproducibility on datasets, and comparison of software results to visual assessments by MQSA-qualified radiologists using both one- and two-view mammography images. Clinical beta site testing was also conducted to assess integration and usability. All tests met acceptance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/20/2017
7 months - 2
FDA Approval
6/26/2018
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