Formus Hip
Formus Labs, LtdFormus Hip is a preoperative planning software designed to assist orthopedic surgeons by automatically generating 3D models of the hip from CT scans and overlaying digital representations of hip implants. It uses AI algorithms for image segmentation and statistical shape modeling, helping clinicians plan hip replacement surgeries more effectively by customizing implant fitting interactively and producing printable surgical plans.
Intended Use
Formus Hip is a preoperative surgical planning software intended to assist qualified medical professionals in preoperative planning of orthopedic surgical procedures.
Technology
Formus Hip uses AI-based automatic image segmentation algorithms trained on CT scans to create 3D models of the femur and pelvis. It employs statistical shape models for implant fitting and allows user interaction for plan customization. The software imports pre-dimensioned CT images and overlays a database of hip implant geometries to assist in surgical planning.
Performance
Non-clinical testing showed the device met accuracy criteria for 3D image segmentation comparing AI-generated models to manual segmentations by radiologists, with Dice scores ≥0.9 and mean distances ≤2 mm. Implant sizing validation demonstrated >90% agreement within ±2 sizes compared to surgeon-determined sizes, supporting reliability and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2021
1 year, 6 months - 2
FDA Approval
3/31/2023
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