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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the KOBRA™GPS Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the KOBRA™GPS Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The Medtronic Vertelink KOBRA™ GPS Fixation System consists of a variety of cannulated rods and cannulated multi-axial screws used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The KOBRA™ GPS Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The KOBRA™ GPS implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

This document describes a 510(k) premarket notification for the Medtronic Vertelink KOBRA™ GPS Fixation System, a spinal intervertebral fixation device. It asserts substantial equivalence to previously cleared devices rather than presenting a study for acceptance criteria of device performance as one might expect for a novel AI/software medical device.

Therefore, the requested information cannot be fully provided because the provided text does not describe traditional clinical acceptance criteria or a study that proves the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to already approved predicate devices, which is the basis for 510(k) clearance.

Here's an explanation based on the provided text, highlighting what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or a performance study comparing the device against such criteria. The "performance" assessment is based entirely on demonstrating substantial equivalence to predicate devices through documentation, including "test reports." However, the nature of these test reports and their specific criteria, device performance, and results are not detailed in the provided summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The "test reports" mentioned are not described in detail. For mechanical devices like spinal fixation systems, "test sets" typically refer to samples of the device undergoing mechanical or material testing, not human patient data in the way an AI/software device would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI-driven devices. For a mechanical implant, the "ground truth" would be established by engineering specifications, material science, and biomechanical principles, not clinical expert consensus on diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable and not provided. Adjudication methods are typically used for clinical endpoints or diagnostic assessments, not for demonstrating substantial equivalence of a mechanical device.

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

Not applicable and not provided. MRMC studies are relevant for evaluating the impact of AI on human readers (e.g., radiologists, pathologists). This device is a mechanical implant, not an AI or diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable and not provided. This device is a mechanical implant, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As noted in point 3, the concept of "ground truth" as typically applied to diagnostic or AI devices is not directly applicable here. For a mechanical device, "ground truth" regarding its safety and effectiveness would be established through:

• Engineering specifications and material properties: Conformance to established standards for materials, dimensions, and manufacturing.
• Biomechanics and mechanical testing: Data from cadaveric studies, in-vitro fatigue testing, pull-out strength, and other mechanical tests to demonstrate performance under simulated physiological loads.
• Clinical experience with predicate devices: The safety and effectiveness of the existing predicate devices (Vertelink KOBRA™ Fixation System and CD HORIZON® Spinal System) serve as the precedent for the new device based on substantial equivalence.

8. The sample size for the training set

Not applicable and not provided. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable and not provided.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device (spinal fixation system) to previously cleared predicate devices. It does not contain information about clinical performance studies, reader studies, AI algorithms, or specific acceptance criteria in the way one would describe for an AI/software medical device. The "documentation, including test reports" mentioned is the basis for the substantial equivalence claim, but the details of these tests are not included here.

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