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The Proficient™ Posterior Cervical Spine System is intended to immobilize and stabilize the spine as an adjunct to fusion for cervical (C2-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, 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 Proficient™ Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient™ Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient™ transition rods.

The Proficient™ Posterior Cervical Spine System consists of a selection of non-sterile, single use polyaxial screws, set screws, rods, and cross-connector components manufactured from titanium (ASTM F136 and ASTM F67) and cobalt chrome alloys (ASTM F1537 and ASTM F1058). The surgeon attaches the rod, screw, and cross connectors to the cervicothoracic region of the spine in order to stabilize the spine during fusion of vertebral bodies.

This document is a 510(k) premarket notification for the Proficient™ Posterior Cervical Spine System. It describes a medical device, not an AI/ML-driven device or study with acceptance criteria related to a diagnostic or predictive algorithm. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document.

The performance data listed in Section 8 of the 510(k) summary are for mechanical testing of the spinal implant device, not for the performance of an AI system. These tests are:

• Static and dynamic compression bending (per ASTM F1717)
• Static and dynamic torsion (per ASTM F1717)
• Axial grip (per ASTM 1798)

These are standard engineering tests to evaluate the physical properties and durability of the spinal system and are used to demonstrate its substantial equivalence to predicate devices, rather than meeting acceptance criteria for an AI system's performance.

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