OTS Hip is a surgical system designed to assist orthopedic surgeons in planning and performing total hip arthroplasty (hip joint replacement) surgeries. It uses CT images of the patient's hip anatomy to create a detailed 3D model, enabling precise preoperative planning and real-time intraoperative navigation. This image-guided system improves surgical accuracy and helps position compatible hip prostheses according to the pre-planned locations, enhancing patient outcomes.
Intended Use
OTS Hip is indicated to enable planning of orthopedic surgical procedures based on CT medical imaging data. It is an intraoperative image-guided localization system that enables navigated surgery by linking a freehand probe to virtual computer image space on preoperative image data. The system assists in accurately navigating a compatible prosthesis to the preoperatively planned position, particularly for total hip arthroplasty using a posterior approach.
Technology
OTS Hip consists of software (OTS Hip Plan for 3D preoperative planning and OTS Hip Guide for intraoperative navigation) and hardware (camera, computer stand, passive marker sensors called Tracers, adapters, and surgical instruments). The system uses medical imaging data in DICOM format from CT scans, performs automated landmark detection and segmentation using fixed machine learning algorithms, and provides real-time navigation during surgery via infrared tracking of passive markers.
Performance
The device underwent quantitative system-level validation under clinical conditions demonstrating accuracy within acceptable limits for inclinations, anteversions, and leg length measurements. Electrical safety and EMC testing confirmed compliance with IEC 60601 standards. Machine learning algorithms for segmentation and landmark detection were validated against expert manual annotations using a test dataset of 90 cases from multiple countries, showing acceptable performance overall. Design verification and non-clinical simulated surgical environment testing confirmed all functional and safety requirements were met.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/18/2023
7 months - 2
FDA Approval
3/11/2024
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