BriefCase-Quantification
Aidoc Medical, Ltd.BriefCase-Quantification by Aidoc Medical is an AI-driven software designed to analyze non-cardiac-gated, non-contrast CT scans including the heart to detect and categorize coronary artery calcification (CAC). It provides physicians with a four-category risk assessment for coronary artery disease along with preview images of detected calcium, assisting clinical evaluation but not replacing full image review or clinical judgement.
Intended Use
Software intended for analysis of non-cardiac-gated non-contrast CT images including the heart in adults aged 30+. Assists physicians by providing four-category Coronary Artery Calcification (CAC) plaque risk assessment with preview axial images for informational purposes only. Results not for standalone clinical decision-making; clinicians responsible for full image review.
Technology
BriefCase-Quantification is a standalone software as a medical device running on a Linux-based cloud server. It processes filtered routine, non-contrast, non-gated CT scans to evaluate calcified plaques in coronary arteries using AI, producing a four-category calcium score output consistent with validated visual assessment and clinical guidelines. Results are integrated into PACS or desktop review software for physician assessment.
Performance
A retrospective, blinded multicenter study on 433 distinct cases showed BriefCase-Quantification achieved 87.1% overall agreement with ground truth in classifying coronary artery calcification categories, meeting prespecified performance goals. Category-level agreement ranged from 81.3% to 95.1%. Performance is equivalent to predicate and reference devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/5/2023
5 months - 2
FDA Approval
11/28/2023
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
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- BriefCase-Triage2024 • 510K
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