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When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The Spinal Concepts, Inc. Nex-Link Spinal Fixation System consists of a series of longitudinal members, anchors, and transverse connectors. The Nex-Link system is intended for fixation to, and stabilization of, the cervicothoracic spine.

Nex-Link implants are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F-136 or commercially pure titanium per ASTM-F-67.

The provided document is a 510(k) summary for the Spinal Concepts, Inc. Nex-Link Spinal Fixation System. It describes the device, its indications for use, and mentions that mechanical test data was provided to support the 510(k) notification. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in a way that aligns with the questions posed (e.g., related to AI/algorithm performance, ground truth, expert review, sample sizes for training/test sets).

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the questions related to a study proving the device meets those criteria, as the document does not contain this information. The document focuses on regulatory approval based on substantial equivalence to a predicate device and mechanical testing, not on clinical performance metrics as typically presented for AI/software devices.

The only relevant information from the prompt for the questions is that "Mechanical testing data, collected in accordance with ASTM F1717-01 and ASTM F1798-97, were provided to support this 510(k) notification." This indicates a type of testing, but not the specific data or criteria outcomes.

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