Bunkerhill AVC
BunkerHill HealthBunkerhill AVC is a medical software designed to automatically detect and quantify calcium deposits on the aortic valve using non-contrast chest CT scans. It helps physicians by providing a region of interest and an estimated calcium score to assist during case review, improving the identification and assessment of aortic valve calcification in adult patients.
Intended Use
Bunkerhill AVC is a software device intended for use in detecting presence and estimating quantity of aortic valve calcification for adult patients aged 40 years and above, analyzing non-gated, non-contrast chest CT images and outputting region of interest and calcium quantification to assist physicians.
Technology
The device is software as a medical device (SaMD) that interfaces with commercially available CT systems to automatically detect, localize, and quantify aortic valve calcification in non-gated, non-contrast chest CT scans. It uses deep-learning algorithms to estimate an Agatston-equivalent score and provides visual circular ROI outputs for detected calcifications.
Performance
Performance was validated in a retrospective study comparing the device output against ground truth across 33 sites in the US, showing agreement within predefined acceptance criteria based on Bland-Altman analysis. The device achieved precision of 0.826 and recall of 0.855 for region of interest detection, demonstrating performance comparable to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/8/2024
3 months - 2
FDA Approval
1/27/2025
Other devices from BunkerHill Health
- Bunkerhill Abdominal Aortic Quantification (AAQ)2025 • 510K
- CAC (gated) Algorithm2024 • 510K
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