cmTriage
CureMetrix, InccmTriage is a software tool that uses artificial intelligence to analyze 2D digital mammograms and flags suspicious cases to help radiologists prioritize which exams to review first. It integrates with the Picture Archiving and Communication System (PACS) worklist but does not alter images or provide diagnostic results. cmTriage aims to improve the efficiency of breast cancer screening workflows by identifying potentially abnormal cases for quicker attention.
Intended Use
cmTriage is a passive notification for prioritization-only, parallel-workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D FFDM screening mammograms. cmTriage uses an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level.
Technology
cmTriage is a software-only device consisting of Image Forwarding and Result File Receiving Software, Image Processing and Analysis Software hosted in the cloud, which analyzes de-identified encrypted DICOM 2D FFDM images using an AI algorithm to identify suspicious findings and generates a DICOM Structured Report (SR) code flagged as “Suspicious” or blank that updates the PACS worklist accordingly.
Performance
A retrospective, blinded, multi-center study was conducted using 1255 mammographic studies (400 biopsy-proven cancers and 855 normal cases). cmTriage achieved a sensitivity of 86.9% and specificity of 88.5%, exceeding targets based on Breast Cancer Surveillance Consortium (BCSC) benchmarks. The area under the curve (AUC) was 0.951 across densities and lesion types. Average processing time was 3.35 minutes per case, within clinical operational expectations for screening.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/26/2018
3 months - 2
FDA Approval
3/8/2019
Other devices from CureMetrix, Inc
- cmAngio� V1.02023 • 510K
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