cvi42 Auto Imaging Software Application

“cvi42 Auto is a software as a medical device (SaMD) that is intended for evaluating CT and MR images of the cardiovascular system.”

“cvi42 Auto uses machine learning techniques to aid in semi-automatic contouring of regions of interest of cardiac magnetic resonance (MR) or computed tomography (CT) images as follows: 1. Cardiac Function: semi-automatic contouring of the four heart chambers (including left ventricle, left atrium, right ventricle, right atrium) in MR images. 2. Calcium Assessment: using pixel intensity technique, identify calcified plaque in major coronary arteries in non-contrast enhanced CT images. 3. Coronary Analysis: semi-automatic placement of centerline in coronary vessels to visualize the coronary arteries and assess stenosis in non-contrast enhanced CT images.”

“The data used to train these machine learning algorithms were sourced from multiple clinical sites from urban centers and from different countries. When selecting data for training, the importance of model generalization was considered and data was selected such that a good distribution of patient demographics, scanner, and image parameters were represented. The separation into training versus validation datasets is made on the study level to ensure no overlap between the two sets. As such, different scans from the same study were not split between the training and validation datasets. None of the cases used for model validation were used for training the machine learning models.”

“Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance documents “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices”.”