AiORTA - Plan
K250337ViTAA Medical Solutions, Inc. · cleared 2025-10-30 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The AiORTA - Plan tool is an image analysis software tool for volumetric assessment.”
source quote (p.6)
“Segmentation: an Al-powered auto-masking algorithm performs segmentation of the aortic lumen, wall, and key anatomical landmarks, including the superior mesenteric, celiac, and renal arteries.”
source quote (p.9)
“Cybersecurity risks for the web-based configuration of the subject device have been extensively analyzed and mitigated.”
Validation studies (2)
Reader study (MRMC)
n=40 scans
endpoints: ≥ 80% Dice coefficient achieved for the aortic wall and aortic lumen masks; Key anatomical landmarks were identified within 5mm of ground truth; Overall Mean Dice coefficient of 89% achieved for the aortic wall; Overall Mean Dice coefficient of 89% achieved for the aortic lumen masks; Celiac artery proximal position: Mean distance 2.47mm; Renal arteries distal position: Mean distance 3.51mm; Mean absolute error ≤ 6.0mm for length; Mean absolute error ≤ 2.3mm for diameters; Renal artery to aortic bifurcation: mean absolute error 5.3 mm; Renal artery to left iliac bifurcation: mean absolute error 7.0mm; Renal artery to right iliac bifurcation: mean absolute error 6.6mm; Aortic wall max: mean absolute error 2.0 mm; Aortic wall at renal artery: mean absolute error 2.1 mm; Aortic wall at left iliac bifurcation: mean absolute error 1.9mm; Aortic wall at right iliac bifurcation: mean absolute error 2.5 mm; Length: renal to left iliac bifurcation (Expert-expert MPAD) 7.1mm; Length: renal to left iliac bifurcation (Device-expert MPAD) 6.9mm; Length: renal to right iliac bifurcation (Expert-expert MPAD) 10.4mm; Length: renal to right iliac bifurcation (Device-expert MPAD) 9.6mm; Diameter: wall right iliac (Expert-expert MPAD) 2.7mm; Diameter: wall right iliac (Device-expert MPAD) 2.5mm
standards: IEC 62304:2006+A1:2015 Medical device software - Software life cycle processes, ISO 14971: 2019 Application of risk management to medical devices, IEC 62366 Medical devices - Part 1: Application of usability engineering to medical devices
Bench
n=40 scans
endpoints: Mean absolute error ≤ 1.8 mL; Volume of the Wall: Mean absolute error 0.00242 mL, standard deviation of errors: 0.00280 mL; Volume of the Lumen: Mean absolute error 0.00257mL, standard deviation of errors: 0.00300mL
standards: IEC 62304:2006+A1:2015 Medical device software - Software life cycle processes, ISO 14971: 2019 Application of risk management to medical devices, IEC 62366 Medical devices - Part 1: Application of usability engineering to medical devices
Reported performance (2 observations)
source quote (p.10)
“Overall Mean Dice coefficient of 89% achieved for the aortic wall”
source quote (p.10)
“Overall Mean Dice coefficient of 89% achieved for the aortic lumen masks”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K254207 (decision 2026-03-30) from ViTAA Medical Solutions, Inc. for a matching device line ("AiORTA - Plan v2.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K254207
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).