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It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine.

The components in the Solanas® Posterior System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods.

· Degenerative Disc Disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

• · Spondylolisthesis
• · Spinal Stenosis
• Fracture/Dislocation
• Atlanto/Axial fracture with instability
• · Revision of previous cervical spine surgery
• Tumors.

The Solanas® Posterior Stabilization System is a spinal fixation system intended to improve stability of the occipital, cervical, and thoracic areas of the spine (C1-T3).

The purpose of this submission is to obtain premarket clearance for Co-Cr28-Mo6 rods for the Solanas® Posterior Stabilization System and to demonstrate that the subject device, Solanas® Posterior Stabilization System, is substantially equivalent to the predicate devices. Co-Cr28-Mo6 rods are for cervical/thoracic use only.

This document is a 510(k) premarket notification for the Alphatec Spine, Inc. Solanas® Posterior Stabilization System. It details the device, its indications for use, and its substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria or a study proving that a device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or AUC for an AI-powered medical device.

The document primarily focuses on demonstrating the substantial equivalence of modifications (specifically, the addition of Co-Cr28-Mo6 rods) to an existing spinal fixation system. The "Performance Data" section mentions "Static and Dynamic Compression Bending, Static and Dynamic Torsion and Axial Grip" tests, which are typical mechanical tests for spinal implants, not algorithmic performance evaluations.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of an AI-powered medical device for this specific document.

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