Salix Coronary Plaque (V1.0.0)

Salix Coronary Plaque is a web-based software application for viewing, post-processing, and analyzing cardiac CT images. It provides cardiologists and radiologists with interactive tools to quantify and characterize coronary plaques, assess stenosis, and perform calcium scoring on non-contrast cardiac CT scans. The software is intended as an adjunctive diagnostic tool to complement—not replace—physician decision-making.

Salix Coronary Plaque operates as a client-server Google Chrome application hosted on Amazon Web Services, DICOM 3.0 or higher compliant. It includes semi-automated vessel and plaque segmentation (manual and user-editable), multiple measurement capabilities (distance, area, vessel/lumen profiles), 2D/3D imaging with MPR and MIP, and calcium scoring. Compared to CaRi-Plaque, it adds calcium scoring and expanded quantitative outputs (burden metrics, plaque composition categories); compared to Salix Central, it provides additional burden calculations and plaque composition classification.

FDA 21 CFR Part 820.30 (Design Controls), IMDRF/SaMD WG/N12FINAL:2014, ISO 13485:2016 (Quality Management), IEC 62304:2015 (Software Lifecycle), ISO 14971:2019 (Risk Management), and NEMA 3.1-3.20 (2016) DICOM standards. FDA Guidance documents on Software Premarket Submissions and Cybersecurity in Medical Devices were also followed.

The device shares identical intended use and clinical application with both predicates (CaRi-Plaque and Salix Central)—analyzing cardiac CT for coronary plaque and stenosis assessment. Technological differences are minor: the added calcium scoring capability and expanded quantitative measurements are supported by comprehensive clinical validation demonstrating that eight routine CCTA-trained readers achieved expert-level performance (95.8% stenosis categorization within one CAD-RADS grade, ICC values 0.61–0.96 for plaque volumes) against board-certified reference standards across multiple scanner vendors. Performance testing across diverse datasets exceeded all pre-defined acceptance criteria, establishing that these functional enhancements do not introduce unique safety or effectiveness questions.