cvi42 Coronary Plaque Software Application
Circle Cardiovascular Imaging, Inc.The cvi42 Coronary Plaque Software Application is a medical software tool that assists physicians in analyzing coronary CT angiography images. It uses AI and machine learning algorithms to help detect and quantify the presence and extent of coronary plaques and stenoses in patients, providing measurements and visualization to aid diagnostic decision-making for coronary artery disease evaluation.
Intended Use
The device is intended for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular CT images to assess the presence and extent of coronary plaques and stenoses in coronary CT angiography (CCTA) images in an adult population.
Technology
The device is a Software as a Medical Device (SaMD) that uses AI/ML algorithms for semi-automated segmentation and detection of lumen and vessel wall structures from CT Angiography images. It provides multiplanar reconstruction, curved planar reformation, 3D rendering, and quantitative plaque volume and burden measurements. All surfaces generated are editable with manual correction possible. It integrates with other cardiac image visualization software.
Performance
Performance testing including software verification and validation according to FDA guidance, ISO and IEC standards was conducted with no clinical trials needed. Machine learning models were trained and validated on multi-vendor CT data from U.S. sources. Evaluation metrics like Dice Similarity Coefficient, Hausdorff Distance, and Pearson Correlation Coefficient confirmed acceptable accuracy of segmentation and plaque volume measurement. Performance met pre-defined acceptance criteria and was consistent across diverse subgroups. Cybersecurity measures and penetration testing were implemented.
Predicate Devices
No predicate devices specified
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