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The YUKON OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (CI 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 YUKON OCT Spinal 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 YUKON OCT Spinal System may be connected to EVEREST Spinal System components via the rod to rod connectors or transition rods.

The YUKON OCT Spinal System is a top-loading, multiple component, posterior (occipitalcervical-thoracic) spinal fixation system consisting of screws, hooks, rods, rod connectors, and occipital components.

This document describes a 510(k) premarket notification for the YUKON OCT Spinal System. It is a medical device for spinal fixation, not an AI/ML powered device. Therefore, the information requested in the prompt regarding acceptance criteria and a study proving device performance (including details about test sets, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training sets) is not applicable to this type of device.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through:

1. Technological Comparison: Highlighting similarities in design features, materials, and sizes to existing predicate spinal fixation systems.
2. Non-clinical Performance Evaluation: Citing performance evaluation based on published literature and mechanical testing according to ASTM standards (F1717 and F2706) to demonstrate equivalent mechanical properties (static torsion, static compression, dynamic torsion, dynamic compression).

Since the device is a physical spinal fixation system and not a software or AI/ML diagnostic tool, the concept of a "test set" for performance evaluation in the context of diagnostic accuracy, human reader improvement, or algorithm-only performance does not apply. Similarly, "ground truth" for a physical implant is established through design specifications, material properties, and mechanical validation, not expert consensus on images or outcome data in the same way it would be for a diagnostic algorithm.

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