AiORTA - Plan v2.0
ViTAA Medical Solutions, Inc.AiORTA - Plan v2.0 is a cloud-based software that uses AI to analyze cardiovascular CT angiography scans to assist clinicians in assessing aortic aneurysms. It provides 3D visualization, automatic segmentation, measurement of vessel geometry, and pre-operative planning tools to support interventions and post-operative evaluation. Clinicians can manually adjust segmentations and review volumetric changes over time, improving decision-making for patients aged 22 and older.
Intended Use
Image analysis software for volumetric, geometric assessment, and pre-operative sizing and planning based on 3D reconstruction from cardiovascular CTA scans. Intended as adjunct measurement tool in assessment of aortic aneurysm and pre/post-operative cardiovascular intervention evaluation in patients 22 years or older.
Technology
Cloud-based software consisting of an analysis pipeline and web application. The pipeline processes DICOM cardiovascular CTA images, performing automated segmentation using AI auto-masking for aortic lumen, wall, and landmarks. Segmentation masks are converted to 3D meshes to compute geometric parameters such as centerlines, diameters, lengths, and volumes. Users can review and manually edit segmentations, and request re-analysis. Web application provides visualization, measurement tools, longitudinal study comparison, and report generation.
Performance
No additional AI/ML performance testing was performed as the AI algorithms are identical to the predicate device. Software verification and validation testing was conducted for new features and changes in version 2.0, summarized in the Change Traceability Summary and software documentation.
Predicate Devices
No predicate devices specified
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