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The GPS™, G Surgical Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery at levels C2-C7. The system is indicated for temporary stabilization of the anterior spine during the development of cervical fusions in skeletally mature patients with the following indications:

• Degenerative Disc Disease (as defined by neck pain of the discogenic origin with . degeneration of disc confirmed by patient history and radiographic studies)
• Trauma (including fractures) .
• Tumors .
• Deformities or curvatures (including kyphosis, lordosis, or scoliosis) .
• Pseudarthrosis .
• . Failed previous fusion
• . Spondylolisthesis
• . Spinal Stenosis

The GPS™ G Surgical Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, bone screws, locking screws, and associated instruments. Fixation is provided by bone screws, of various lengths, inserted into the vertebral body of the cervical spine using an anterior approach. The GPS™ G Surgical Anterior Cervical Plate System implant components are made from titanium alloy described by ASTM F136 and supplied non sterile. 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 describes the GPS™ G Surgical Anterior Cervical Plate System, an anterior cervical plate system intended for use in spinal fusion surgery. This submission is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than proving de novo safety and effectiveness through clinical trials.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of number of devices tested. The document refers to "Performance testing... included static compression, dynamic compression and static torsion in accordance with ASTM F1717." ASTM F1717 specifies testing methodologies, including sample sizes (e.g., typically a minimum of 6 specimens per test condition for mechanical tests), but the exact number of units tested for this specific device is not disclosed in the summary.
• Data Provenance: The testing was "non clinical testing." The document does not specify the country of origin of the test data or the location where the testing was performed. It is retrospective in the sense that the testing was conducted on manufactured devices to assess their mechanical properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This device approval is based on non-clinical mechanical performance testing, not human interpretation of data where "ground truth" would be established by medical experts (e.g., radiologists). Therefore, this question is not applicable in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable. The "test set" here refers to the mechanical performance testing of the device itself, not to a set of medical images or patient cases requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No MRMC comparative effectiveness study was done. This 510(k) submission did not involve clinical testing or AI assistance. It focused on demonstrating substantial equivalence based on mechanical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No standalone algorithm performance study was done. This device is a surgical implant, not an AI or diagnostic algorithm.

7. The Type of Ground Truth Used

• For the mechanical performance testing, the "ground truth" is defined by the objective measurements obtained from standardized mechanical tests (static compression, dynamic compression, static torsion) as specified by ASTM F1717. The "truth" is whether the device's mechanical properties meet predefined acceptance criteria (implicitly, by being comparable to predicate devices and demonstrating safety and effectiveness for intended use) under these controlled testing conditions.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical implant and does not involve machine learning or a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This device is a mechanical implant and does not involve machine learning or a training set.

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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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