iCAC Device
Bunkerhill, IncThe iCAC Device is a software tool that analyzes routine chest CT scans to automatically detect and quantify coronary artery calcium, which helps physicians assess cardiovascular risk. It provides outputs such as calcium segmentation visualizations and quantitative calcium scores during standard clinical workflows, assisting physicians without replacing original reports or scans.
Intended Use
Software device intended for use in estimating presence and quantity of coronary artery calcium in patients aged 30 years and above during routine care by automatically analyzing non-gated, non-contrast chest CT images and providing calcium segmentation and quantitative estimates (in Agatston units) for physician use as an aid.
Technology
Standalone Software as a Medical Device (SaMD) that uses a deep-learning based computer vision algorithm to analyze DICOM format non-gated, non-contrast chest CT scans and automatically identify and quantify coronary artery calcium burden, providing calcium category and exact Agatston score outputs integrated into physician workflow outputs.
Performance
Performance was validated in a retrospective study of 762 pairs of chest CT and gated coronary CT from nine sites, with overall agreement of 79.7% versus ground truth and positive predictive value between 68.1% and 90.1% for calcium score groups, surpassing acceptance criteria of 73% alignment and 65% PPV.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/26/2023
2 months - 2
FDA Approval
4/25/2023
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