HealthCCS
Zebra Medical Vision Ltd.HealthCCS is a software tool that uses cardiac CT images to automatically identify and measure calcified plaques in the coronary arteries. This helps physicians assess coronary artery disease risk by providing a calcium score and risk category report based on pre-existing CT scans, aiding further clinical decisions and patient management.
Intended Use
The HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. The software can be used to generate reports of the total risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment. The HealthCCS Device analyses pre-existing heart or chest ECG-Gated/Triggered CT scans. The Device is indicated for use only on patients whose age at the time, when the CT scan was taken, was above 20 years old. This device generates a 4-category Agatston-equivalent risk score, and the patient management, especially for the patient with the score from 0-10, will depend on the physician’s own judgment. It may require further testing to evaluate the appropriate clinical management.
Technology
HealthCCS is an automatic non-invasive post-processing tool that uses cardiac CT images to identify and quantify calcification in the coronary arteries, known to be a risk factor for coronary disease. The device identifies calcification based on voxel density above a threshold of 130 Hounsfield Units (HU), applies a CNN-based probability threshold to determine whether calcium is associated with coronary arteries, then calculates a coronary artery calcium score using the Agatston method. It generates patient risk category reports based on the calcium score. The technology and operation are substantially equivalent to predicate devices that use similar thresholds, scoring methods, and CT modalities, focusing on heart/chest ECG-gated CT scans without contrast.
Performance
The HealthCCS device was validated in a retrospective study on 249 CT scans comparing its four-level risk categorization with ground truth determined by three radiologists using a reference device. It demonstrated an overall agreement of 0.89 (95% CI: 0.85-0.92) and showed reproducibility with identical results on repeated readings. The results support acceptable accuracy, precision, and reproducibility. The study concluded HealthCCS performs similarly to predicate and reference devices sharing the same intended use and technology, with no new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2017
8 months - 2
FDA Approval
6/13/2018
Other devices from Zebra Medical Vision Ltd.
- HealthPPT2021 • 510K
- HealthCCSng2021 • 510K
- HealthJOINT2020 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.