CogNet QmTRIAGE
MedCognetics, Inc.CogNet QmTRIAGE is an AI-powered software tool designed to analyze 2D digital mammograms to prioritize patients with suspicious breast findings. It flags exams suggestive of cancer to help mammography interpreting physicians prioritize their workflow, aiding early detection without replacing full diagnostic evaluation.
Intended Use
A passive notification, prioritization-only, parallel-workflow software tool used by MQSA qualified interpreting physicians to prioritize patients with suspicious findings on 2D FFDM screening mammograms.
Technology
Software as a medical device (SaMD) that uses AI algorithms to analyze 2D FFDM mammograms, providing an exam-level output flagging suspicious studies to a PACS/workstation for worklist prioritization. Operates in parallel with standard care without removing images from physician worklists. Cloud-based deployment.
Performance
Validated on 800 anonymized 2D FFDM mammograms including 399 biopsy-positive cancer cases and 401 negative cases, achieving AUROC of 0.9569, sensitivity of 87%, and specificity of 89%. Dataset included data from multiple continents and multiple mammography vendor systems.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/10/2022
8 months - 2
FDA Approval
9/29/2022
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