“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set

The POINT Kinguide Agile Hybrid Navigation System is an image-guided surgical system that uses infrared optical tracking to help surgeons locate anatomical structures during neurosurgical and orthopedic procedures. It tracks the position of surgical instruments in relation to patient anatomy by monitoring Dynamic Reference Frames and matches coordinates to intraoperative 3D imaging. The DRF Accessories Set enables navigation of compatible surgical instruments during spinal implant procedures, specifically pedicle screw placement in the T12-S1 vertebrae (or T1-S1 with the RobotArm).

The subject device shares the same technological characteristics as its predicates: X-ray based imaging modalities, fiducial frame-based rigid anatomical positioning, skin marker registration features, optical infrared localization (Northern Digital Vega), C++ programming language, Intel-based PC platform, and identical system accuracy performance of ≤2.0 mm positional error and ≤2.0° trajectory error. Medical device interfaces, planning features, view/display features, and GUI design are equivalent across all compared devices.

Testing complies with ISO 14971:2019 (risk management), IEC 62366-1:2015 (usability engineering), IEC 60601-1/1-2/1-8 (electrical safety), ASTM F2554-22 and F3107-14 (positional accuracy), ISO 10993-1:2018 (biocompatibility), IEC 62304:2006+A1:2015 (software validation), AAMI TIR12:2020 and ANSI/AAMI ST98:2022 (reprocessing), ISO 17665:2024 (sterilization), and ASTM F2825-18, D4169-22, and F1980-21 (stability and reliability).