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The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

• degenerative disc disease (DDD) as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis. .
• trauma (i.e., fracture or dislocation), .
• spinal stenosis, .
• atlantoaxial fracture with instability, .
• occipitocervical dislocation, .
• revision of previous cervical spine surgery, and/or .
• . spinal tumor.
  The occipital bone screws are limited to occipital fixation only.
  The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

A new occipital plate design is being added to the Sierra spinal system. All products are fabricated from titanium alloy and cobalt alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.

This document is a 510(k) premarket notification for the Sierra™ OCT Spinal System, specifically for the addition of a new occipital plate design. It is a submission to the FDA (Food and Drug Administration) for regulatory clearance. Since this is a submission for a Special 510(k) and the information provided points to substantial equivalence with existing predicate devices, the focus is on design and material equivalency, rather than clinical performance studies involving a test set, ground truth, or human-in-the-loop assessments as would be done for AI/ML-driven devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission. The "acceptance criteria" here refer to satisfying FDA's requirements for substantial equivalence based on design, materials, and intended use.

Here's the breakdown of the information based on the provided document:

1. A table of acceptance criteria and the 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)

• Not applicable (N/A). This submission is for a medical device (occipital plate) and relies on substantial equivalence to predicate devices, not clinical performance data from a test set of patients in the way an AI/ML device would. No patient data or test set in the traditional sense was used.

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)

• N/A. Ground truth establishment is not relevant for this type of submission, which focuses on engineering and design equivalency.

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

• N/A. No test set or human adjudication process as described is relevant.

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

• N/A. This is not an AI/ML device, so no MRMC study or AI assistance evaluation was conducted.

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

• N/A. This is not an algorithm or AI system.

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

• N/A. The "ground truth" equivalent in this context is the regulatory acceptance of the predicate devices based on their established safety and effectiveness. The new device is deemed safe and effective because its characteristics are substantially equivalent to those already cleared devices.

8. The sample size for the training set

• N/A. No training set is relevant for this device.

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

• N/A. No ground truth for a training set was established.

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