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The Synapse OCT System, including Synapse, OC Fusion and Axon, is intended to provide immobilization and stabilization 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 thoracic spine (T1-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 arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the instability. The Synapse 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.

In order to achieve additional levels of fixation, the Axon and Synapse Systems may be connected to the Synthes Universal Spinal System using parallel connectors and tapered rods. The Synapse OCT System can also be linked to the titanium DePuy EXPEDIUM Spine System using the 3.5mm/5.5mm titanium tapered rods.

The Synapse OCT System, including Synapse, OC Fusion and Axon consists of screws, hooks, rods, plates, transverse bars, parallel connectors, transconnectors, and locking screws. These implants are designed for fixation of the occiput, cervical, and/or upper thoracic spine (Occiput – T3). A complete OCT construct can be created by using components that have been previously cleared within the CerviFix, Axon, Synapse and OC Fusion Systems. The components of the Synapse OCT System are manufactured from Titanium Alloys, similar to the predicate device.

The provided document is a 510(k) premarket notification letter and summary for the Synapse Occipital-Cervical-Thoracic (OCT) System. This document describes a medical device, specifically a spinal fixation system, and its substantial equivalence to a predicate device. It does not contain information about the performance of an AI/ML device, nor does it present acceptance criteria or a study proving an AI/ML device meets such criteria.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) as it pertains to an AI/ML device from this document. The "Performance Data" section refers to bench testing of the mechanical properties of the spinal fixation system (implants), not an AI/ML diagnostic or prognostic tool.

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