Intended Use

CT VScore+ is a software application intended for non-invasive evaluation of calcified lesions of the coronary arteries based on ECG-gated, non-contrast cardiac CT images for patients aged 30 years or older. The device automatically generates calcium scores for the coronary arteries (combined LM+LAD, RCA, LCX) and highlights the segmented calcium on the original CT image. The device also offers the option for the user to display the calcium scores in the context of reference data from the MESA and Hoff-Kondos databases. The segmentation map of calcifications is intended for informational use only and is not intended for detection or diagnostic purposes.

Technology

CT VScore+ incorporates a deep learning algorithm using a proprietary Attention UNet architecture to segment coronary calcifications on ECG-gated, non-contrast cardiac CT DICOM images, automatically generating Agatston and volume calcium scores for combined LM+LAD, RCA, and LCX arteries. It runs on the Vitrea platform and allows user manual edits. The device outputs calcium scores and 3D rendered calcium views for supplementary visualization.

Performance

Performance testing included validation on 236 independent patient cases with deep learning model development on 210 cases. The device demonstrated high agreement with ground truth manual scoring by board-certified physicians, achieving ICC >0.99 for total scores, high kappa scores for risk classification, and robust segmentation accuracy (Dice score ≥0.87 per vessel). Performance was consistent across scanner types (Canon, GE, Siemens, Philips), slice thickness, noise levels, patient demographics, and disease severity. No new safety or effectiveness concerns were identified.

Predicate Devices

No predicate devices specified

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