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The Caspian OCT/miniMesa/miniDenali Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and 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, atlantoaxial fracture with instability, occipitocervical dislocation.

The occipital bone screws are limited to occipital fixation only.

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 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. Rod connectors and transitional rods are being added to the system.

Materials: The devices are manufactured from Ti6A14V 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 (TI-T3) spine.

The provided text is a 510(k) summary for the Caspian Spinal System, which is a medical device for spinal fixation. It describes the device, its intended use, and its comparison to predicate devices for substantial equivalence.

However, a critical review of the document reveals that it does not contain any information regarding clinical studies, acceptance criteria, or performance metrics in the way that would typically be described for a diagnostic AI/ML device.

The relevant sections of the document describe:

• Device Description: A top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system made from Ti6A14V Eli and Cobalt Chrome.
• Intended Use: Provides stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for various conditions.
• Comparison to Predicate Devices: Mechanical testing (static and dynamic compression bending and static torsion) was performed in accordance with ASTM F1717. The additional components were determined not to represent worst-case for the system for mechanical testing compared to existing components. The design features, sizing, materials, and intended uses were found to be substantially the same as predicate devices (K2M Caspian Spinal System and DePuy Mountaineer).

Therefore, I cannot provide the requested information for acceptance criteria and study details because the provided document does not contain this type of data.

This document is a 510(k) summary for a spinal implant (a mechanical device), not a diagnostic AI/ML device. For spinal implants, the "acceptance criteria" and "study" typically refer to mechanical testing (e.g., fatigue, static strength, bending stiffness) and biocompatibility testing, rather than clinical performance metrics like sensitivity, specificity, or reader studies associated with diagnostic algorithms.

The document states:
"Mechanical testing of the subject components included static and dynamic compression bending and static torsion testing in accordance with ASTM F1717. When compared to the existing components of the K2M Caspian OCT Spinal System, the additional components were determined not to represent worst case for the system for mechanical testing."

This indicates that mechanical tests were done, and the results were deemed equivalent to the predicate device, implying they met the predicate's performance. However, specific numerical acceptance criteria or performance results (e.g., "device withstood X N of force") are not provided in this summary.

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