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The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

The given text describes a medical device, the uCerv Flux™-C 3D Porous Titanium Cervical Interbody, and its 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device through performance testing. However, it does not contain information related to acceptance criteria or studies involving AI or human-in-the-loop performance.

Therefore, for the information requested regarding acceptance criteria, AI studies, human experts, and ground truth for AI model development, I must state that this information is not present in the provided document.

The document details mechanical testing for the interbody device to demonstrate substantial equivalence to predicate devices, but this is a different type of evaluation than what is asked for in the prompt.

Here's a breakdown of what is available in the document related to performance, even though it's not about AI:

1. A table of acceptance criteria and the reported device performance

The document states that the performance data for the uCerv Flux™-C 3D Porous Titanium Cervical Interbody included:

• Static and dynamic axial compression according to ASTM F2077.
• Static and dynamic torsion according to ASTM F2077.
• Subsidence according to ASTM F2267.
• Expulsion tests.

The reported performance is that "The mechanical test results demonstrate that the uCerv Flux™-C 3D Porous Titanium Cervical Interbody performance is substantially equivalent to the predicate devices."

However, specific numerical acceptance criteria (e.g., "must withstand X N of force") and detailed numerical results are NOT provided in the text. It only states the tests performed and the conclusion of substantial equivalence.

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

Not applicable, as the evaluation is mechanical testing of physical device units, not a dataset for an AI model. The document does not specify the number of devices tested in the mechanical studies.

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

Not applicable, as the evaluation is mechanical testing, not expert-based assessment.

4. Adjudication method for the test set

Not applicable, as the evaluation is mechanical testing, not a read study requiring adjudication.

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, this type of study was not done or mentioned. The device is a cervical interbody fusion device, not an AI diagnostic tool.

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

No, this is not an AI algorithm.

7. The type of ground truth used

For the mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices. The document implies compliance with ASTM standards, which provide established methodologies and expected performance ranges for such devices.

8. The sample size for the training set

Not applicable, as there is no mention of an AI training set.

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

Not applicable, as there is no mention of an AI training set.

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