Paradigm System

The Paradigm System is a stereotaxic image guidance system for spine surgery that combines real-time camera imaging of the surgical site with preoperative CT data and navigation software to guide precise placement of pedicle screws in the thoracic to sacrum vertebrae. It is used during open posterior approach spine surgery with appropriate bone preparation.

The subject device uses the same stereotaxic image-guided surgical navigation approach as the predicate, with identical components (cart, arm, sensor array, external monitor, surgical instruments, software), energy source (120V), and sterilization methods (steam for instruments, ethylene oxide for the optional drape accessory). The only difference is the addition of an optional Paradigm Drape accessory that was not present in the predicate device.

IEC 60601-1, IEC 60601-1-2, IEC TS 60601-4-2, IEC 60601-1-6, IEC 60825-1, IEC 62366-1, ISO 10993-1, ISO 14971, ISO 17665-1, ANSI/AAMI ST79, ASTM F2554-22, ANSI/AAMI ST98, ISO 11135, ISO 11607-1, IEC 62304, AAMI TIR 28.

The subject device is substantially equivalent because it maintains identical indications for use, intended use, principle of operation, components, technical specifications, and regulatory classification as the predicate. The only material change is an optional drape accessory that does not affect the core device functionality. Verification and validation testing including non-clinical hardware/software verification, cadaveric design validation, and compliance conformity assessments demonstrate that this optional accessory does not raise new safety or effectiveness risks.