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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks, rods, and cross connectors are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, cross connectors and locking breakaways.

Here's a breakdown of the acceptance criteria and study information for the SOLSTICE OCT System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The performance data refers to a dynamic testing study, which typically involves mechanical testing rigs rather than human or animal subjects that would generate "data" in the conventional sense of clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study presented is a dynamic mechanical test (ASTM F1717) and not a study that requires human interpretation or expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the study presented is a dynamic mechanical test (ASTM F1717) and does not involve subjective assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided information focuses on mechanical performance testing and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This is not applicable. The device is a physical spinal fixation system, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for this device's performance is established by technical specifications and standards, specifically:

• ASTM F1717: Standard mechanical test method for spinal implant constructs. The "ground truth" is that the device must meet or exceed the performance parameters defined by this standard, or demonstrate comparable performance to predicate devices tested under the same standard.
• ASTM F136: Standard specification for implantable titanium alloy. The "ground truth" is the material composition meeting this standard.

8. Sample Size for the Training Set

This is not applicable as the device is a physical spinal implant system and does not involve AI or machine learning that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

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