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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 junction, 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 spinal fixation 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 system to fit the patient'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 (e.g., cross connectors) to link the longitudinal components for additional stability.

The provided text does not contain information about acceptance criteria for a device, nor does it detail a study proving that the device meets specific acceptance criteria based on metrics like sensitivity, specificity, or accuracy.

The document is an FDA 510(k) clearance letter for the SYMPHONY™ OCT System, a spinal fixation system. It confirms that the device is substantially equivalent to legally marketed predicate devices. The "Performance Data" section (Section I) describes non-clinical mechanical testing performed to demonstrate substantial equivalence, but these are not presented as acceptance criteria for device performance in terms of diagnostic accuracy or a similar clinical measure.

Therefore, I cannot provide the requested information.

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