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The Cranial Fusion 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 (C1to 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 Cranial Fusion 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 Cranial Fusion System may be connected to the Spine NAUTILUS Spine System using the 3.5mm/5.5mm titanium parallel connectors.

The Cranial Fusion 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 information describes a medical device, "The Cranial Fusion System," cleared by the FDA. However, the document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of the device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document because it is not typically included in this type of submission.

The document does mention:

1. Performance Data: Static compression, dynamic compression, dynamic, and static torsion testing according to ASTM F2706 was presented to demonstrate substantial equivalency. This indicates that mechanical testing was performed, but the specific acceptance criteria and detailed results are not provided in this summary.
2. Ground Truth and Training Set Information: This information is not applicable as this is a medical implant, not an AI/algorithm-based diagnostic device where such terms are typically used for validation.

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