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The NorthStar™ OCT 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, cervical spine (C1-C7) and upper thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• · Failed previous fusion (e.g. pseudoarthrosis);
• · Tumors involving the cervical/thoracic spine;
  • Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
  · Degenerative disease of the facets with instability.

The NorthStar OCT 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.

The NorthStar OCT System can also be linked to other SeaSpine Screw Systems including Mariner, NewPort, Sierra, Atoll, Daytona, Malibu, Mariner Outrigger, and Mariner Midline Systems with the use of transitional rods and/or transitional rod connectors.

The NorthStar™ OCT System is a spinal fixation system intended to improve the stability of the occipital, cervical, and thoracolumbar areas of the spine. The NorthStar™ OCT System consists of screws, hooks, rods, offset connectors, set screws, cross connectors, transition implants, occipital plates and associated instruments. Implant components are available in a variety of sizes and can be constructed into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission includes indication for the use of bone screws in the occipital, cervical spine (C1-C7), and upper thoracic spine (T1-T3). The implants are manufactured from medical grade titanium alloy and cobalt chrome.

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the NorthStar™ OCT Spinal System. It details the device, its indications for use, and its substantial equivalence to previously marketed predicate devices.

However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. The device described is a spinal implant system with mechanical components (screws, rods, etc.). The non-clinical testing mentioned refers to mechanical performance tests against ASTM standards (e.g., static and dynamic axial compression, torsion testing), not the performance of an AI algorithm on a test set.

Therefore, I cannot provide the requested information from the given text because it is a submission for a hardware medical device, not a software/AI medical device. The concepts of "test set," "ground truth," "expert consensus," "MRMC study," and "standalone algorithm performance" are specific to the evaluation of AI/ML-based medical devices, which are not relevant to this 510(k) submission for a spinal implant.

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