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The Caspian Spinal System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Revision of previous cervical spine surgery
• Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.

The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.

Materials: The devices are manufactured from Ti6Al4V Eli and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the cervical and thoracic (T1-T3) spine.

The provided text describes the 510(k) summary for the Caspian Spinal System, a spinal fixation system. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies.

The document focuses on:

• Identification of the device: Trade name, common name, classification, product code, regulatory class.
• Predicate devices: Listing similar legally marketed devices.
• Description of the device: Components, materials, function.
• Intended Use/Indications for Use: Specific conditions for which the device is intended.
• Substantial Equivalence Claim: Stating that the device is similar in design, material, and indications for use to predicate devices and is expected to be equivalent in safety and effectiveness.
• FDA Correspondence: Official letter acknowledging the 510(k) submission and determining substantial equivalence.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as the necessary information is not present in the provided text.

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