Cleerly Plaque
Cleerly, Inc.Cleerly Plaque is a cloud-based software tool that helps doctors analyze coronary CT angiography (CCTA) scans by automatically identifying and measuring plaque buildup in the coronary arteries. By providing detailed and quantitative insights, it supports clinicians in assessing and managing coronary artery disease.
Intended Use
Cleerly Plaque is a software module used in conjunction with Cleerly LABS, designed to assist in the evaluation of coronary artery disease (CAD) by identifying, characterizing, and quantifying coronary plaque in patients undergoing coronary computed tomography angiography (CCTA).
Technology
Cleerly Plaque is a cloud-based, modular software add-on for the Cleerly LABS platform. It uses machine learning algorithms and rule-based image processing to automate the detection, labeling, and quantitative analysis of atherosclerotic plaque on CCTA images, supporting interactive visualization and manual adjustment of analysis outputs.
Performance
Cleerly Plaque underwent extensive software verification and validation including module-level and system-level testing, and a performance evaluation using 120 de-identified U.S. CCTA studies with expert-annotated references. Performance metrics such as overlap ratio and correlation of plaque/lumen/vessel volumes all met or exceeded predefined standards, demonstrating accurate and reliable results. No clinical studies were needed, as non-clinical testing was sufficient.
Predicate Devices
No predicate devices specified
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