CaRi-Plaque

CaRi-Plaque is a web-based software application that analyzes cardiac CT images to quantify and characterize coronary artery plaque and stenosis. It provides healthcare professionals with quantitative measurements including plaque volume, calcification status, and stenosis severity to support clinical decision-making about coronary artery disease treatment.

CaRi-Plaque uses threshold-based segmentation algorithms versus the predicate's machine learning approach, and operates as a web-based application with remote operator capability versus the predicate's desktop workstation model. Both devices perform 2D/3D imaging analysis, provide equivalent core quantitative measurements (maximum stenosis, total plaque volume, calcified and noncalcified plaque volumes), and require trained operators to review and generate reports.

Not stated in this summary. The document references software verification and validation testing and clinical validation using Pearson Correlation Coefficients and Cohen's Kappa for statistical analysis, but does not cite specific ISO, IEC, or ASTM standards.

CaRi-Plaque has the same intended use as the predicate device (analyze CT images for coronary plaque and stenosis to aid treatment decisions). While the submission technology differs (web-based, threshold-based segmentation, remote operators), both devices perform identical core clinical functions and output equivalent measurements. The clinical validation study demonstrated excellent correlation (Pearson r = 0.930–0.999 for primary endpoints) between CaRi-Plaque and expert ground truth, matching the predicate's validation approach. The minor technological differences do not raise different safety or effectiveness questions because both accomplish the same clinical purpose with verified performance equivalence.