Deepvessel

Listed Item

DEEPVESSEL Plaque (“DVPlaque”, the subject device) is a web-based image analysis application for the purpose of characterizing and quantifying plaque and stenosis in coronary arteries based on previously acquired CCTA DICOM data. DVPlaque applies deep learning neural networks to segment coronary arteries, lumen and vessel walls, which will be reviewed and edited by trained and qualified analysts, if needed. Plaque, stenosis, and vessel measurements are outputted based on the analyst-editable segmentation, utilizing simple rule-based mathematical calculation. DVPlaque provides a visualization of DVPlaque analysis in two reports – Cardisight Overview Report and Plaque Analysis Report. In Cardisight Overview Report, location and CAD-RADS stenosis category of the plaque are visually over-viewed in a simplified 2D model if stenosis and plaque exist. In Plaque Analysis Report, quantitative characteristics of the plaque, including total plaque volume, calcified plaque (CP) volume, non-calcified plaque (NCP) volume, low-density plaque (LDP) volume, and plaque burden (defined as percent plaque volume and calculated as total plaque volume/vessel volume) are outputted both on main vessel branch level and on patient level. Reports of DVPlaque are provided to clinicians to enable them to assess the presence and extent of coronary plaque, aiding in determining treatment paths. These reports are not intended to be the final report used in patient diagnosis and treatment, and should be reviewed with other clinical information.Clinicians may request a re-analysis of the CCTA DICOM data if they do not agree with the report analyses.