CAC (gated) Algorithm
BunkerHill HealthThe CAC (gated) Algorithm is a software medical device designed to automatically detect and quantify coronary artery calcium from non-contrast ECG-gated cardiac CT scans. It aids physicians by providing calcium segmentation and quantification information integrated into their workflow, helping assess coronary artery health.
Intended Use
CAC (gated) is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above. The device automatically analyzes non-contrast electrocardiogram (ECG) gated cardiac computed tomography (CT) images collected and outputs the segmentation (intended for informational purposes only) and quantification of detected calcium.
Technology
CAC (gated) is a software medical device (SaMD) that interfaces with compatible and commercially available CT systems to localize and quantify coronary artery calcium by automatically analyzing ECG-gated cardiac CT images. The output includes calcium segmentation and quantification displayed to physicians on-demand within their standard workflow.
Performance
Performance testing included clinical and software validation demonstrating the device's ability to automatically detect and quantify coronary artery calcium with results intended to assist physicians during review. The output is not intended for stand-alone diagnosis, supporting safety and effectiveness as an aid.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/7/2024
7 months - 2
FDA Approval
9/27/2024
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