Rapid Aortic Measurements

Rapid Aortic Measurements is a software tool that analyzes CT images of the chest, abdomen, and pelvis to segment and visualize the aorta and iliac arteries. It produces 2D and 3D images, measurements of vessel diameters, and centerline reconstructions to aid physician decision-making in evaluating aortic and iliac arteries.

Both Rapid Aortic Measurements and the predicate Rapid Neuro3D are SaMD modules using AI/ML with 3D segmentation and 2D/3D vessel visualization outputs (volume renderings, curved planar reformations, multiplanar reconstructions). Rapid AM processes CECT, CTA, CTPA, and NCCT datasets; Rapid Neuro3D processes only CTA. Both run on standard hardware in cloud-hybrid configurations and interface with PACS/viewers.

ISO 14971:2019 (risk management), IEC 62304:2015 (software lifecycle), IEC 62366-1:2015 (usability engineering), NEMA PS 3.1-3.20 (DICOM), and ISO 15223-1:2021 (symbols and labeling). Cybersecurity assessed via Vulnerability Assessments, SBOMs, and penetration testing.

Both devices perform automated vessel segmentation and provide 3D/2D visualizations with analogous technical implementations. Rapid AM's measurement outputs were validated against ground truth with mean absolute error of 0.22 cm, comparing favorably to the reference device Rapid RV/LV. Segmentation quality and accuracy studies with 108 cases across multiple scanner manufacturers showed 100% clinical accuracy agreement and Dice coefficients of 0.93, demonstrating that Rapid AM raises no new safety or effectiveness issues relative to the predicate.