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The Posterior Cervical Spine 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 thoracic spine from T1-T2:

(1)Traumatic spinal fractures and/or traumatic dislocations.

(2)Instability or deformity.

(3)Failed previous fusions (e.g. pseudarthrosis).

(4)Tumors involving the cervical spine.

(5)Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Posterior Cervical Spine System consists of pedicle screws, nut, rods, connectors, hook, transconnectors, laminar hooks, occipital plates and occipital screw.

The implants in Posterior Spine Cervical System is made from Ti-6A1-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472.

The implants are provided as sterile or non-sterile, while the instruments are provided as non-sterile.

The implants are intended for single-use only, while the instruments are reusable.

The provided text is a 510(k) summary for a medical device (Posterior Cervical Spine System) and does not describe acceptance criteria, device performance, or details of a study involving AI or human readers. The document explicitly states:

"No clinical performance data was provided to demonstrate substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample size for testing/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the given input.

The document focuses on demonstrating substantial equivalence through:

• Comparison of Technological Characteristics: Stating similarity in regulatory classification, indications for use, materials, and design features to predicate devices.
• Non-Clinical Performance Data: Referring to biocompatibility testing (in accordance with FDA Guidance "Use of International Standard ISO 10993-1") and mechanical testing (per ASTM F2706-08, ASTM F543-17, and ASTM F1798-13) to ensure the device's physical properties are safe and effective.

No AI-related information or clinical study details are present in this document.

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