AiORTA - Plan v2.0

AiORTA – Plan v2.0 is a cloud-based software tool that analyzes cardiovascular CT scans to generate 3D reconstructions and geometric measurements of the abdominal aorta and external iliac arteries. It provides adjunct information to healthcare practitioners for assessment of aortic aneurysms, pre-operative evaluation, surgical planning, and post-operative follow-up in patients 22 years and older, but is not intended for standalone diagnosis.

The subject device uses fully automated segmentation with an AI-powered masking algorithm, whereas the predicate required manual corrections by ViTAA analysts. Version 2.0 expands the anatomical scope to include external iliac arteries and descending aorta, provides clinicians with a full suite of manual editing tools, and adds C-ARM calculations and institution-based device suggestions from lookup tables. The AI/ML algorithms themselves are identical to the predicate.

Not stated in this summary.

AiORTA Plan v2.0 is substantially equivalent to the predicate AiORTA Plan v1.1 because both are medical image management and processing systems for the same anatomical region and clinical indications. While v2.0 adds automated analysis capabilities, expanded anatomical coverage, and enhanced user tools, these enhancements provide clinicians with additional information and control without raising new safety or effectiveness questions. The core measurement algorithms and intended use remain functionally equivalent.