IntraOp Alignment System; CONTOUR3D Bending System
Alphatec Spine, Inc.The IntraOp Alignment System is a software-based system that interfaces with a mobile C-arm fluoroscope to acquire and stitch bi-planar radiographic images during spinal surgery. It allows healthcare professionals to measure spinal alignment and create patient-specific rod plans intraoperatively. The CONTOUR3D Bending System uses these rod plans to automatically bend spinal rods according to surgeon specifications in the operating room. Together, they assist clinicians in spinal surgery through imaging analysis and precise rod shaping.
Intended Use
The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery. It assists healthcare professionals in viewing, storing, and measuring spinal alignment images during surgery, planning surgical procedures including user-defined rod planning. The CONTOUR3D Bending System is intended to intraoperatively bend compatible spinal rods based on user-defined plans and data from the IntraOp system.
Technology
The IntraOp Alignment System is a software-based system interfacing with mobile C-arm fluoroscopy to acquire, stitch, and display bi-planar images for spinal alignment assessment and rod planning. It tracks C-arm position using an optical sensor and reflective markers to ensure accurate spatial imaging. The CONTOUR3D Bending System is an automated electromechanical device that intraoperatively bends spinal rods according to the rod plan exported from the IntraOp system. Both systems are intended for use in operating rooms by trained professionals.
Performance
Performance testing included system-level accuracy tests verifying rod planning and bending tolerances (max local deviation ≤ 3.5 mm, RMSE ≤ 5.0 mm), and spinal alignment measurement accuracy (angles < 4 degrees, distances < 5 mm (3 mm pediatric)). Additional verifications for image stitching, C-arm tracking, and usability were performed. Cybersecurity, sterilization, biocompatibility, EMC and electrical safety testing were also conducted successfully.
Predicate Devices
No predicate devices specified
Ready to Sharpen Your Edge?
Subscribe to join 11k+ 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.