BriefCase-Quantification of Coronary Artery Calcification (CAC)

The Coronary Artery Calcification Quantification solution is a standalone software as a medical device intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart to assist hospital networks and appropriately trained medical specialists. The BriefCase-Quantification receives filtered routine, non-contrast, non-gated computed tomography (CT) scans, and processes them chronologically by running the algorithm on relevant series to evaluate calcified plaques in the coronary arteries. Following the AI processing, the output of the algorithm analysis is transferred to an image review software (the PACS or a desktop application). The device generates a four-category output corresponding with the estimated quantity of calcium detected: very low, low, medium, and high. The categories composing the output of the device correspond with a validated visual assessment categorization of none, mild, moderate, and severe [1] in agreement with categorized Agatston scores indicated in the literature (very low: 0; low: 1-100; medium: 101-400; high: ≥400). In addition, the categories accord with the 2016 SCCT/STR guidelines for coronary artery calcium scoring of non-contrast non-cardiac chest CT scans and are used as standard of care in clinical practice during CAC assessment in NCCT scans. The Coronary Artery Calcification Quantification software generates a preliminary summary report that is provided in the desktop application that includes applicable user warnings, the CAC detection category and number of slices that include CAC. The report presents preliminary results only and instructs the user to review the full image and any other clinical information before making a clinical decision. For all analyzed scans, the user will be presented in the PACS with all the slices containing the measured coronary calcifications. On these images, the calcified areas will be represented to provide the user visibility on the areas which supported the category output. These slices will be presented along with the original slices. Preview images of the represented calcium are non-diagnostic and are available in the PACS for informational purposes only.