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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

Hooks and Rods-The rod and hook components are also intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods and Pedicle Screws-The rods and screws are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

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 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 document is a 510(k) summary for the Caspian Spinal System, a medical device. It does not contain information about acceptance criteria or a study proving performance in the context of device performance metrics like sensitivity, specificity, accuracy, or any statistical measures typically associated with AI/software device evaluation.

Instead, this document focuses on establishing substantial equivalence to legally marketed predicate devices, a regulatory pathway for physical medical devices. The "study" mentioned here is the comparison to predicate devices, asserting similarities in design, material, and indications for use.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (MRMC, standalone algorithm performance) is not applicable or cannot be extracted from this specific document.

I will fill in the table and address the questions to the best of my ability based on the provided text, indicating when information is "Not Applicable" or "Not Provided."

Description of the Acceptance Criteria and Study

The Caspian Spinal System seeks clearance through the 510(k) pathway by demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" in this context are not performance metrics like accuracy or sensitivity, but rather the demonstration that the new device is as safe and effective as existing, legally marketed devices.

The "study" that proves the device meets "acceptance criteria" is the detailed comparison of its technological characteristics, materials, and intended use against those of the identified predicate devices. The conclusion of this comparative analysis is that the Caspian Spinal System is "substantially equivalent" to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not Applicable. This is a comparison to predicate physical devices, not a performance study on a test dataset.
• Data Provenance: Not Applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. "Ground truth" in the context of diagnostic or AI performance is not relevant for this type of 510(k) submission for a spinal implant system. The "ground truth" here is the established safety and effectiveness of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this submission is implicitly the established safety and effectiveness track record of the predicate devices based on their prior regulatory clearance and market experience.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not Applicable.

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