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The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at one level from C2 - T1. The System is intended to be used with supplemental fixation; the CoRoent SHL interbody device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The NuVasive CoRoent Small Interbody System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, and titanium alloy conforming to ASTM F136 and ISO 5832-3 or tantalum conforming to conforming to ASTM F560 or ISO 13782. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided document is a 510(k) premarket notification for a medical device, the NuVasive® CoRoent® Small Interbody System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a new study.

Therefore, the document does not contain the kind of information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, or AI performance metrics.

Specifically, the document states:

• No new studies were performed: "No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional nonclinical testing was required or performed."
• Performance data relied on existing literature: "A systemic literature analysis of published clinical data for cervical interbody fusion devices similar to the CoRoent Small Interbody System was provided as performance data to support the expanded Indications for Use."

As such, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided, as no new performance data was generated.
2. Sample sized used for the test set and the data provenance: Not applicable, as no new test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
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 device does not contain software or electrical equipment and is not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for the reasons above.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable for the reasons above.
9. How the ground truth for the training set was established: Not applicable for the reasons above.

In summary, this document is a regulatory submission demonstrating substantial equivalence based on existing device characteristics and a literature review, not a new study with acceptance criteria and measured performance.

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