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The SOLSTICE 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, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): Traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic 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 SOLSTICE 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 SOLSTICE Spinal System may be connected to the titanium Life Spine NAUTILUS Spine System using the 3.5mm titanium parallel connectors.

The hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods, and locking caps.

The provided text is a 510(k) Pre-market Notification from the FDA regarding the "Solstice OCT System," a spinal implant device. This document details the device's indications for use, its description, and a summary of performance data to demonstrate substantial equivalence to predicate devices.

However, the information provided does not contain any details about AI/ML algorithm performance, acceptance criteria for such an algorithm, or studies proving an algorithm meets those criteria. The performance data mentioned refers to static and dynamic mechanical testing of the physical spinal implant parts (per ASTM F1717), not the performance of a digital diagnostic or AI-powered system.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving a device meets those criteria, as the input document describes a physical medical device (spinal implant) and its mechanical testing, not a device involving AI or software performance.

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