OTS Hip is an orthopedic surgical system designed to aid surgeons in preoperative planning and intraoperative navigation of hip replacement surgeries. It uses CT and X-ray medical imaging data and combines software and hardware components to create a 3D model of the patient's unique anatomy, guiding surgical instrument and prosthetic placement in real-time. This helps improve the accuracy and safety of total hip arthroplasty procedures.
Intended Use
OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT and X-Ray medical imaging data of the patient anatomy. It is an intraoperative image-guided localization system that enables navigated surgery by linking a tracked freehand probe to virtual computer image space on the patient's preoperative image data.
Technology
The system includes software for 3D preoperative planning (OTS Hip Plan) and intraoperative navigation (OTS Hip Guide), using a stereotaxic system with hardware components including a real-time optical tracking system, camera, and computer. It uses machine learning algorithms for segmentation and landmark identification from CT and X-ray data to generate 3D models, and tracks instruments and implants in real-time during surgery.
Performance
Performance validation included human cadaver studies to test system accuracy for inclination, anteversion, position error, and leg length inequality, demonstrating equivalence with the predicate device. The device passed electrical safety and EMC standards. Machine Learning algorithms were validated against annotated ground truth datasets, including 90 CT and 503 X-ray images representing diverse populations. Design verification tested localization accuracy per ASTM standards and risk management per ISO 14971.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/13/2025
4 months - 2
FDA Approval
5/16/2025
Other devices from Ortoma AB
- OTS Hip2024 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.