ElucidVivo A.3

ElucidVivo A.3 is an image analysis software package that processes CT images of arterial vessels to provide clinicians with quantitative measurements of vessel structure and plaque composition, aiding in the stratification of patients with atherosclerosis. The system incorporates improved technological characteristics, including kVp calibration and the use of MOVAT stain for ground truth comparison, to enhance the accuracy of identifying plaque components like Lipid Rich Necrotic Core, matrix, and calcifications.

ElucidVivo A.3 is an image analysis software package designed for evaluating CT images of arterial vessels. Its primary purpose is to assist trained physicians in the stratification of patients with atherosclerosis by enabling the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT scanners. The software provides multi-dimensional visualization and tools for measuring and analyzing anatomy and pathology, including semi-automatic determination of contrasted lumen boundaries, stenosis measurements, lumen diameters, Hounsfield unit statistics, and vessel length. Clinicians can view highlighted vessels in 3D, rotatable curved MPR views, and cross-sections, with the ability to edit lumen boundaries. ElucidVivo A.3 is intended as a complementary tool to the standard of care and not for direct diagnosis or clinical recommendations. The ElucidVivo A.3 system represents an improvement over its predicate by enhancing measurement performance for Lipid Rich Necrotic Core (LRNC), matrix (MATX), and calcifications (CALC). This was achieved by incorporating considerations for different energy levels through kVp calibration for plaque component measurement and by adopting MOVAT stain, which offers superior fidelity for LRNC delineation compared to the H&E stain used previously. Performance data was established through software verification and validation, including testing with phantom and clinical images. The evaluation focused on calculations of anatomic structure (compared to manual measurements and assessing inter/intra-reader variability) and tissue characteristics (compared to histopathologic specimens as ground truth). Analytic performance metrics such as bias, slope, intercept, RMSE, and wSD were reported for various structural and compositional measurements, alongside a note on potential overestimation of stenosis by diameter in very small lumens.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the kVp calibration algorithm in ElucidVivo A.3 account for variability in CT scanner manufacturers and protocols to ensure consistent plaque component measurements?; What is the quantitative improvement in LRNC, matrix, and calcification delineation when using MOVAT stain as ground truth compared to the previous H&E stain methodology, and how does this impact inter-observer variability in histopathological assessment?; Given the acknowledged limitation for stenosis by diameter in small lumens, what specific quantitative threshold or guidance does ElucidVivo A.3 provide for clinicians to switch to qualitative assessment or alternative metrics like %stenosis by area?; How were the phantom and clinical images selected for validation testing, and do these datasets represent a diverse range of atherosclerotic plaque morphologies and patient demographics?; What are the implications of the reported bias and RMSE values for measurements like lumen area and LRNC area on the potential for misclassification of atherosclerosis severity, and how are these uncertainties communicated to the clinician?