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The GPS ™, G Surgical Pedicle System is a pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the GPS ™, G Surgical Pedicle System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the GPS ™, G Surgical Pedicle System is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

The GPS ™, G Surgical Pedicle System is a top-loading anterior / posterior spinal fixation system which consists of Mono and Polyaxial pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The GPS ™ implant components are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.

The GPS ™, G Surgical Pedicle System can be used in both the anterior and posterior planes providing unilateral and bilateral modes of fixation.

The GPS ™, G Surgical Pedicle System design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a preassembled washer in the housing component between screw and the rod which tightens against the head of the pedicle screw upon connection of the set screw with the rod.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the GPS ™, G Surgical Pedicle System implants.

The provided text is a 510(k) premarket notification for a medical device called the GPS™, G Surgical Pedicle System. This document focuses on establishing substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in the way that an AI/ML device submission would.

Therefore, I cannot provide the requested information. The document does not describe:

• Acceptance criteria in a quantitative sense (e.g., target specificity, sensitivity, or accuracy).
• A study demonstrating device performance against such criteria.
• Sample sizes for test or training sets, data provenance, expert ground truth establishment, or multi-reader studies.
• Standalone performance or the type of ground truth used as these concepts are not applicable to this type of device submission.

The document primarily outlines the device's intended use, description, and confirms that it has been deemed substantially equivalent to predicate devices, thus allowing it to be marketed.

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