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The NuVasive Reline Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Reline Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Reline Cervical System may be connected to the Nu Vasive® SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline® 4.5-5.0 System via the rod to rod connectors or transition rods.

The NuVasive Reline Cervical System is an occipito-cervico-thoracic posterior system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The Reline Cervical System consists of a variety of components including screws, rods, offset connectors, rod to rod connectors, set screws, cross connectors, hooks, eyelets, and occipital plates which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

The NuVasive® Reline® Cervical System is a medical device designed to provide immobilization of spinal segments as an adjunct to fusion for various spinal instabilities. The device's acceptance criteria and the study proving it meets these criteria are detailed below based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing conducted to demonstrate substantial equivalence to a predicate device. While explicit numerical acceptance criteria values are not given, the overall criterion is that the subject device performs equivalently to the predicate device in specific mechanical tests.

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

The document does not specify the exact sample sizes used for each of the mechanical tests (Static and dynamic compression bending, static torsion, dynamic torsion, static tulip pull-off). The data provenance is non-clinical testing, implying in-vitro mechanical testing rather than patient data. Thus, there is no country of origin or retrospective/prospective classification applicable in this context.

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

This section is not applicable as the device is a mechanical implant and the testing described is non-clinical mechanical performance testing. Ground truth for such tests is typically established through adherence to industry standards (like ASTM F2706 mentioned) and engineering specifications, not expert medical consensus.

4. Adjudication Method for the Test Set

This is not applicable to the non-clinical mechanical testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned in the document. The studies conducted were non-clinical mechanical performance tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a physical spinal implant, not an algorithm or AI-driven system.

7. Type of Ground Truth Used

The ground truth for the performance testing was based on mechanical performance standards and specifications, specifically ASTM F2706 and potentially other internal engineering acceptance criteria to demonstrate substantial equivalence to the predicate device.

8. Sample Size for the Training Set

This is not applicable. The device is a mechanical implant, not an AI or machine learning system that requires a training set. The testing performed was non-clinical mechanical performance testing.

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

This is not applicable for the reasons stated in point 8.

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