HealthJOINT
Zebra Medical Vision Ltd.HealthJOINT is a software product that assists clinicians by using artificial intelligence to create 3D models of knee bones from standard 2D X-ray images. This helps surgeons with preoperative planning for knee surgeries by providing detailed anatomical landmarks and accurate bone reconstructions, improving clinical assessment and surgical preparation.
Intended Use
A software tool for 3D reconstruction of bones from a set of 2D radiographs, intended to assist clinicians in preoperative planning of knee orthopedic surgical procedures.
Technology
HealthJOINT uses an artificial intelligence algorithm to analyze AP and lateral knee X-rays to automatically generate 3D bone models and identify anatomical landmarks. It interfaces via API with third-party software for further analysis and display.
Performance
Performance was validated in a retrospective study comparing HealthJOINT 3D reconstructions to CT scans in 67 patients. The software showed low root mean square error values for femur, tibia, and fibula reconstructions and accurate landmark positioning within predefined success criteria, demonstrating safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/31/2020
3 months - 2
FDA Approval
12/4/2020
Other devices from Zebra Medical Vision Ltd.
- HealthPPT2021 • 510K
- HealthCCSng2021 • 510K
- HealthMammo2020 • 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.