Lower Limb AI (LLAI)
AI Planning Logic, Inc.Lower Limb AI (LLAI) is a cloud-based software tool that uses artificial intelligence to segment bones and measure limb alignment from lower-limb CT scans. It helps orthopedic surgeons plan knee osteotomy procedures by providing 3D models and quantitative data to support surgical decision-making.
Intended Use
Software intended for use by orthopedic healthcare professionals in the preoperative planning of knee osteotomy procedures. Processes CT images of the lower limb to provide automated segmentation, 3D reconstruction, quantitative measurement of limb alignment, and anatomical visualization for surgical planning support.
Technology
Cloud-based, deep-learning model for bone segmentation; deterministic geometric algorithms for quantitative measurements; browser-accessed web interface; GPU-accelerated inference; cybersecurity controls; no patient-contacting components.
Performance
Performance testing included retrospective validation of segmentation, landmark localization, angle measurement, 3D STL representation, and workflow function, with both internal and independent external datasets. All prespecified acceptance criteria were met (e.g., Dice ≥ 0.95, HD95 ≤ 3.5 mm for segmentation; mean Dice 0.9916–0.9965, mean landmark error 3.6–4.2 mm). No unresolved safety concerns. Clinical outcome improvements were not assessed.
Predicate Devices
No predicate devices specified
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