Autoplaque
Cedars-Sinai Medical Center: AIMAutoplaque 3.0 is a post-processing software designed for use with coronary CT angiography images. It helps cardiologists and radiologists analyze coronary arteries to detect and measure plaques and stenosis. The AI-driven software automates vessel, plaque, and lumen segmentation with an option for clinician review, enabling faster and more standardized cardiac image analysis.
Intended Use
Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. It is a workstation-based post processing application intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses.
Technology
Autoplaque 3.0 is a stand-alone software performing post-processing of coronary CTA images using computerized algorithms. It includes deep learning-based vessel, plaque, and lumen segmentation which is reviewed by clinicians, allows 2D and 3D image review with quantitative tools to measure various plaque and vessel parameters, and runs on Windows or Mac OS.
Performance
Performance was validated through software verification, multicenter clinical studies comparing expert reader measurements with the device on over 201 US and 175 non-US patient datasets, demonstrating excellent agreement in measurements of total plaque volume, calcified and non-calcified plaque volumes, and diameter stenosis. The device runs faster than the predicate with similar accuracy. Correlation with predicate and expert readers confirms equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/31/2021
1 year, 8 months - 2
FDA Approval
5/19/2023
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