Visage Breast Density
Visage Imaging GmbHVisage Breast Density is a software application designed to analyze mammography images and classify breast density into categories according to the ACR BI-RADS Atlas 5th Edition. It uses a convolutional neural network to assist radiologists by providing adjunctive information about breast tissue composition, making breast density assessment more efficient.
Intended Use
Visage Breast Density is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. It assesses breast density from a mammography study and provides an ACR BI-RADS Atlas 5th Edition breast density category to aid radiologists in the assessment of breast tissue composition. It produces adjunctive information and is not a diagnostic aid.
Technology
Visage Breast Density employs a convolutional neural network (CNN) trained on a large database of mammography exams for automatic classification of breast density into four categories. It is designed as an add-on to the Visage 7 product for distributing, viewing, processing, and archiving medical images. It uses mammography studies stored on the Visage 7 server and displays the breast density classification in the Visage 7 client.
Performance
Performance testing was conducted using two independent datasets of 500 and 700 mammography studies from different sites, with breast density classification performed by three board-certified radiologists to form a consensus ground truth. The AI's predicted breast density categories were compared to this ground truth and clinical reports.The results showed Visage Breast Density achieved similar accuracy per category and overall compared to the predicate device, confirming sufficient accordance and consistent performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/28/2020
8 months - 2
FDA Approval
1/29/2021
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