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The intended use of the Certex Spinal Fixation System is to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g., pseudoarthrosis);
• · Tumors involving the cervical/thoracic spine; and

· Degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The X-spine Certex Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The X-spine Certex Spinal Fixation System can be linked to X-spine Fortex® Pedicle Screw System and X-spine Xpress™ Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.

The Certex Spinal Fixation System consists of polyaxial screws, hooks, rods, occipital plates, occipital bone screws, cross bar connectors, lateral offset connectors and rod-to-rod connectors. System components can be connected and locked together to promote fusion of the occipitocervico-thoracic spine (Occiput-T3). System components are offered in various sizes and configurations to accommodate variations in pathology and individual patient anatomy. All Certex Spinal Fixation System components are manufactured from Titanium alloy (Ti6AI4V) in accordance with ASTM F136.

The purpose of this submission is to expand the indications of the Certex Spinal Fixation System to include cervical pedicle screw indications.

The provided document is a 510(k) premarket notification for the "Certex Spinal Fixation System." It focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner typically seen for new AI/medical software devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/software device cannot be extracted from this document, as it is for a mechanical spinal fixation system.

However, I can extract the information related to the performance testing that was conducted for this mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document describes mechanical testing of a physical device, not a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered standards and measurements, not expert consensus on medical images or outcomes.

4. Adjudication method 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: For mechanical testing, the "ground truth" would be the established engineering standards (ASTM F1717, ASTM F2706, ASTM F1798) and the performance characteristics of the predicate devices.

8. The sample size for the training set: Not applicable. This document does not describe a training set in the context of an AI/software device.

9. How the ground truth for the training set was established: Not applicable.

Additional Information from the document regarding the mechanical testing:

• Performance Testing: "Performance testing and a detailed literature search indicates the Certex Spinal Fixation System is as mechanically sound as predicate devices. Testing included static compression, static torsion, dynamic compression, and dynamic torsion per a modified version of ASTM F1717, ASTM F2706 and sub-assembly testing in ASTM F1798. The results demonstrate that the acceptance criteria defined by predicate device performance were met."

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