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The Centurion POCT System is intended 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 fraumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT 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 Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium allov or Cobalt Chrome allov, that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, cross connectors, parallel and axial connectors, lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.

This FDA 510(k) K180025 submission describes a modification to an existing device, the Centurion POCT System, specifically a design change to the set screw component of the cross connector to include a retention feature. It is a Special 510(k) submission, meaning it relies on previously established substantial equivalence and focuses on the impact of the modification.

Therefore, the submission does not contain a new study to prove the device meets acceptance criteria in the traditional sense of a clinical trial or a performance study to establish new clinical efficacy or safety. Instead, the focus is on demonstrating that the modification does not negatively impact the device's performance compared to its predicate device, which was already cleared.

Here's a breakdown of the requested information based on the provided document, much of which will be listed as "Not Applicable" for this type of submission:

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)

• Sample Size for Test Set: Not specified in the document. For static mechanical testing, the "sample size" would typically refer to the number of test articles (modified set screws/cross connectors) tested to meet the ASTM F1798-13 standard.
• Data Provenance: Not specified, but generally, such engineering tests are conducted in a laboratory environment, likely within the manufacturer's R&D or QA facilities, or third-party testing labs.

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. This submission details engineering performance, not interpretative medical decisions. Ground truth in this context is based on physical measurements and compliance with engineering standards.

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

• Not Applicable. This is an engineering verification of a physical device component, not a diagnostic or interpretative study.

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 device is a spinal fixation system, not an AI-assisted diagnostic tool.

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

• Not Applicable. This device is a spinal fixation system, not an algorithm.

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

• Engineering Standards: The "ground truth" for the mechanical testing is defined by the requirements and methodologies outlined in the ASTM F1798-13 standard ("Standard Test Method for Static and Fatigue Bending Properties of a Spinal Rod with Transverse Connectors"). Compliance with these standardized performance metrics constitutes the ground truth for this type of evaluation.

8. The sample size for the training set

• Not Applicable. This is a physical device modification, not a machine learning model.

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

• Not Applicable. This is a physical device modification, not a machine learning model.

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