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The Latitude-C Interbody Spacer is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The Latitude-C Interbody Spacer is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Hyper-C Anterior Cervical Plate System.

Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C Interbody Spacer in the cervical spine.

DeGen Medical Latitude-C Cervical Interbody Spacer is a cervical interbody fusion device for anterior cervical fusion procedures. The Latitude-C spacer has teeth on its superior and inferior surfaces to prevent migration. The Latitude-C spacer comes in 5 different size footprints, and different heights ranging from 5mm to 14mm.

This document describes the DeGen Medical Latitude-C Cervical Interbody Spacer System, a medical device, and its substantial equivalence to predicate devices, rather than a study on an AI/ML device. Therefore, the requested information regarding AI/ML device performance, ground truth, and expert adjudication cannot be extracted from this document.

However, I can provide information about the non-clinical performance testing conducted for the Latitude-C Cervical Interbody Spacer System, which demonstrates its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):

The document states that non-clinical testing was performed in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s”, May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007. The results of these studies showed that the subject device meets or exceeds the performance of the predicate devices.

While specific numerical acceptance criteria and reported performance values are not detailed in this summary, the following tests were performed to demonstrate substantial equivalence:

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

• This document describes non-clinical performance testing of a physical medical device, not an AI/ML model. Therefore, the concepts of "test set" and "data provenance" in the context of AI/ML are not applicable here. The testing involved various mechanical tests on physical samples of the device. The specific number of samples for each test is not detailed in this summary.

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

• Not applicable as this is not an AI/ML device and does not involve ground truth established by experts for a test set. The "ground truth" for these tests would be the established engineering standards and predicate device performance.

4. Adjudication method for the test set:

• Not applicable as this is not an AI/ML device.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used:

• For the non-clinical performance testing, the "ground truth" implicitly refers to the established engineering specifications, performance standards outlined in ASTM and FDA guidance documents, and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device and therefore no training set was involved.

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

• Not applicable as this is not an AI/ML device.

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