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The VERTEX® Reconstruction 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 from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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 instability. The VERTEX® Reconstruction 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.

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

The subject VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, screws, hooks, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® Cable may be used with this system at the surgeon's discretion.

This document describes the regulatory clearance for the VERTEX® Reconstruction System, a medical device used for spinal immobilization and stabilization. It does not contain information about studies involving AI or machine learning algorithms. Therefore, much of the requested information regarding AI study specifics cannot be extracted from this document.

However, I can provide available information related to the device's acceptance criteria and the non-clinical and retrospective clinical studies used to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria (or demonstrated equivalence) and Reported Device Performance

The document states that the VERTEX® Reconstruction System is substantially equivalent to the predicate AXIS® Fixation System. This means the acceptance criteria are not explicit performance metrics in a classical sense, but rather a demonstration that the new device performs at least as well as, and has similar technological characteristics to, the legally marketed predicate.

Regarding the device's "performance": The document does not provide specific numerical performance metrics (e.g., success rates, complication rates) for the VERTEX® Reconstruction System or the predicate device. Instead, it relies on the concept of substantial equivalence, implying that its performance is comparable to that of the pre-existing, legally marketed device.

2. Sample size used for the test set and the data provenance

• Test Set (for clinical data): The document refers to "Retrospective clinical data provided in support of this application along with the published clinical outcomes of additional patients treated with the VERTEX® device for the indications sought." The sample size for the retrospective clinical data is not specified in this document.
• Data Provenance: The available clinical data is retrospective. The country of origin is not specified but is implicitly from the locations where the VERTEX® device has been used or studied.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided document. As this is a medical device clearance based on substantial equivalence, the "ground truth" for clinical outcomes would typically be based on established medical evaluations, but the specific process and expert involvement are not detailed.

4. Adjudication method for the test set

This information is not available in the provided document.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device does not involve AI or human readers for diagnostic interpretation in the context of the provided regulatory submission.

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

No, a standalone algorithm study was not done as this device is a physical implantable medical device, not an algorithm.

7. The type of ground truth used

For the retrospective clinical data, the "ground truth" would implicitly be the clinical outcomes observed in patients treated with the VERTEX® device, evaluated against the accepted medical standards for spinal fusion and stabilization. However, the specific methodology for establishing this ground truth (e.g., pathology, independent outcomes assessment) is not detailed in the document.

8. The sample size for the training set

This information is not applicable/available as this device is a physical implant and does not involve AI or machine learning models that require training sets.

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

This information is not applicable/available as this device is a physical implant and does not involve AI or machine learning models that require training sets and ground truth.

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