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The SYMPHONY 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 unction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudarthrosis);
• · 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 SYMPHONY 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 SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.

The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.

The SYMPHONY OCT System may be connected to the EXPEDIUM® Spine System and VIPER® System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

The SYMPHONY OCT System is a posterior system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The system is composed of multiple components to allow the surgeon to build an implant s anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors) to link the longitudinal components for additional stability.

This document describes a 510(k) premarket notification for the SYMPHONY OCT System, a posterior cervical screw system. The notification primarily focuses on a labeling change permitting reprocessing of previously sterile implants. There is no information provided in this document regarding AI/ML model performance, acceptance criteria, or studies proving device performance against such criteria.

The document states: "No additional testing was conducted to support this submission." This means there is no study included in this submission that evaluates new device performance, including anything related to AI/ML.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance, as the provided text pertains to a different type of medical device submission (a spinal implant system) and explicitly states that no additional testing was conducted.

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