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The Zimmer Virage® OCT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct into fosion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); 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 facets with instability. The Zimmer Virage® OCT 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 advance 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 Zimmer Virage® OCT Spinal Fixation System may be connected to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine, using rod connectors and transition rods. Refer to the Instinct Java and Sequoia Spinal System package insert for a list of the system specific indications of use.

The titanium SONGER® Spinal Cable System to be used with the Zimmer Virage® OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

The Zimmer Spine Virage® OCT Spinal Fixation System is a posterior system intended for the Occipital-Cervical-Thoracic Spine (Occiput-T3). The system consists of a variety of rods, anchors, screws and connectors to build a spinal construct as necessary for the individual patient. The system also includes the instruments necessary for inserting and securing the implants. The implants are intended to be removed after solid fusion has occurred.

The Virage System implants are fabricated from medical grade titanium alloy or medical grade cobalt chromium allov. Implants made from medical grade titanium, medical grade titanium allov. and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are single use only and should not be reused under any circumstances.

The modification is to increase the torque limit used with the Virage® OCT Spinal Fixation System.

The provided text is a 510(k) summary for a medical device called the Zimmer Virage® OCT Spinal Fixation System. It describes the device's indications for use, general description, and claims of substantial equivalence to a predicate device. However, it does not provide detailed information about specific acceptance criteria, comprehensive study designs, or detailed performance data typically associated with a medical device study (such as accuracy, sensitivity, or specificity values).

Here's an analysis based on the provided text, highlighting what is present and what is missing concerning your request:

1. Table of acceptance criteria and reported device performance:

The document states that "Performance mechanical testing was conducted to confirm that the Zimmer Spine Virage® OCT Spinal Fixation System performs as intended and that the fundamental scientific technology remains unchanged from the predicate and referenced devices." It also mentions that the device "demonstrates that the device performs as well as or better than the primary predicate."

However, it does not provide a specific table of acceptance criteria or quantitative performance metrics (e.g., minimum torque values, fatigue life cycles, pull-out strength, etc.) with corresponding reported device performance values. The statement is a general claim of performance.

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

The document mentions "Performance mechanical testing" and "non-clinical tests performed were based on ASTM F2706 and ASTM F1717." However, it does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective). Mechanical testing typically involves material and component testing, not patient data.

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

This information is not applicable to the type of device and study described. This is a spinal fixation system, and the studies mentioned are mechanical performance tests, not studies requiring expert interpretation of clinical data in the same way an AI diagnostic device would.

4. Adjudication method for the test set:

This information is not applicable for the reasons stated in point 3. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure), not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a spinal fixation system, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI improvement metrics are not relevant to this submission.

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

This information is not applicable for the reasons stated in point 5.

7. The type of ground truth used:

For mechanical performance testing, the "ground truth" would be established by the test standards themselves (ASTM F2706 and ASTM F1717) and the physical properties and behavior of the device components under various loads. It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense. It's engineering specifications and observed mechanical responses.

8. The sample size for the training set:

This information is not applicable as there is no mention of an algorithm or an AI component requiring a training set. The study described is mechanical performance testing of a physical medical device.

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

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

In summary, the provided text is a regulatory submission for a physical medical device (spinal fixation system) and focuses on demonstrating substantial equivalence through mechanical testing, not on clinical performance or AI algorithm validation. Therefore, many of the requested data points, which are typically relevant for AI/diagnostic device studies, are not present or applicable.

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