Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Brainlab AGSpine Planning 2.0 is a software tool that helps surgeons plan spinal surgeries using medical images like CT, MR, and X-rays. It uses AI to automatically label vertebrae and suggest spinal implants such as screws and rods, improving accuracy and efficiency during preoperative and intraoperative planning.
Intended Use
Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and planning of spinal implants like screws and rods.
Technology
The software displays 2D X-rays and 3D datasets and includes AI/ML algorithms using a convolutional neural network trained via supervised learning to detect vertebrae landmarks and label vertebrae on imaging. Planning features include automated proposals for screw and rod implants, spinal parameter measurement, and the ability to edit and approve the AI results.
Performance
Performance testing included software verification (unit and integration testing), AI landmark detection assessment, comparison of screw proposal algorithms with predicate device, and summative usability testing. Results showed the device met requirements, displayed similar or improved functionality to predicate, and was user-friendly with no critical use problems.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2022
8 months - 2
FDA Approval
8/2/2023
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