Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
Brainlab SEThe Brainlab Spine Planning (3.0), Spine & Trauma Navigation, and Alignment System Spine help clinicians plan and navigate spine surgeries using advanced image-guided systems. The software uses AI algorithms to automatically label vertebrae and assist in planning implant placement based on CT, MR, and X-ray images, making complex procedures more precise and efficient.
Intended Use
Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures, displaying patient images (CT, Cone Beam CT, MR, X-ray) for implant measurement and planning. Spine & Trauma Navigation supports intraoperative image-guided localization and navigation during spine and trauma surgeries. Alignment System Spine assists with spinal screw placement.
Technology
The software displays 2D X-ray, and 3D CT or MR images, and incorporates AI/ML algorithms for vertebrae detection, labelling, and measurement. It offers planning for screws and rods, and works with navigation platforms using optical tracking technology. Spine Planning integrates an automated sagittal alignment correction workflow that updates rod planning based on the patient's spine curvature.
Performance
Software verification (unit and integration tests) confirmed requirements for the new and modified software components. Usability was validated in simulated clinical use by 15 surgeons, showing effective use of the new sagittal alignment correction and rod bending guidance features. The performance of the AI algorithms for vertebrae labelling and spinal parameter measurement was tested on ~3000 X-ray images, demonstrating close agreement with expert annotations. Additional tests validated the congruence of rod planning with post-op X-rays, and calibration factors for distance measurements. Navigation accuracy, confirmed by prior and new testing, fulfills mean error criteria (≤2 mm position, ≤2° angle), and template-based rod bending was proven more accurate than standard methods.
Predicate Devices
No predicate devices specified
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