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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 OCT/miniMesa/miniDenali 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. Additional hooks 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 and stabilization of spinal segments of the cervical and thoracic (TI-T3) spine.

The provided text is a 510(k) summary for the Caspian OCT Spinal System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, primarily through comparison of technological characteristics and intended use, rather than through extensive new clinical studies with detailed acceptance criteria and performance metrics.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, and ground truth establishment details for a study proving acceptance criteria.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm-only) performance.
• Specific types of ground truth used (beyond general clinical and radiographic studies for indications).
• Training set sample size and ground truth establishment for a training set.

Explanation:

The 510(k) summary explicitly states its purpose is to compare the device to predicate devices. It emphasizes:

• "The subject components were compared to the existing components of the K2M Caspian OCT Spinal System were determined not to represent worst case for the system for mechanical testing.." (Page 1, [0])
• "The design features and sizing of the subject devices were also compared to predicate devices... and found to be substantially the same as these systems. It is manufactured from the same materials and is indicated for the same intended uses as these systems." (Page 2, [1])
• "There are no significant differences between the subject implants and other devices currently being marketed. They are substantially equivalent to these other devices in design, function, material and intended use." (Page 2, [1])

The study referenced is mechanical testing to ensure the new components do not represent a "worst case" for the system, implying a focus on engineering specifications rather than clinical performance metrics typically associated with AI/software device studies. The document does not provide details of this mechanical testing, such as specific acceptance criteria or performance results.

In essence, for this type of medical device submission (spinal fixation system), the "proof" of meeting acceptance criteria is the demonstration of substantial equivalence to already marketed devices, supported by mechanical testing ensuring safety and performance characteristics are maintained, rather than a clinical study evaluating specific performance metrics against pre-defined acceptance criteria for, for example, diagnostic accuracy or treatment efficacy in the way an AI diagnostic tool would.

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