HipCheck
Stryker Corp.HipCheck is a software tool used during hip arthroscopy surgeries that helps surgeons measure the alpha angle related to femoroacetabular impingement (FAI). It processes X-ray images taken during surgery and overlays virtual measurement tools on these images to support clinical decision-making. It also includes a patient-specific report feature for preoperative planning using three-dimensional analyses and visualizations of the hip.
Intended Use
HipCheck assists the surgeon to determine quantitative measurements for femoroacetabular impingement (FAI) procedures by providing static localization information from intra-operative fluoroscopic images through virtual measurement tools.
Technology
The device processes intra-operative X-ray images, overlays virtual measurement tools on a tablet interface, and includes software compatibility updates such as running on Windows 10. It features an AI/ML model for detecting the femoral head and neck with high accuracy using image processing techniques including Gabor filtering, edge detection, and Hough transformation.
Performance
Performance testing included software verification, bench testing, simulated-use design validation by surgeons, and standalone evaluation of the AI/ML model on 745 fluoroscopic images demonstrating high accuracy in detecting and localizing the femoral head and neck. No clinical or animal testing was performed. Device met electrical and mechanical safety standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/6/2023
8 months - 2
FDA Approval
9/29/2023
Other devices from Stryker Corp.
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