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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 up to two contiguous levels 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 a hollow interbody cage manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026. The implant contains a hollow core or graft aperture which allows for packing of autograft to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device includes marker pins composed of titanium alloy conforming to ASTM F136 and ISO 5832-3 or ASTM F1472 or tantalum conforming to ASTM F560 or ISO 13782. The pins serve as radiopaque markers allowing the location and orientation of the device to be seen radiographically during and after the procedure for position confirmation. The implants are available in flat or contoured endplates, and come in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device will be packaged and initially provided non-sterile, and is designed to be sterilized by the user before each use.

This document refers to a 510(k) premarket notification for the NuVasive® CoRoent® Small Interbody System, an intervertebral body fusion device. The purpose of this submission is to modify the Indications for Use to include two-level cervical applications. As such, the presented information focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the expanded indications.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state "acceptance criteria" in terms of numerical thresholds for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance is assessed through a clinical literature review for the expanded two-level indication.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated as a defined "test set" with a specific sample size. The performance is based on a clinical literature review. This means the "sample size" would depend on the number of patients and studies included within that review.
• Data Provenance: The document does not specify the country of origin of the data within the clinical literature review, nor does it explicitly state whether the studies were retrospective or prospective. It only mentions "published clinical literature review."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this submission. The "ground truth" for the modified indication is established through existing published clinical literature, not a new expert review for this specific submission. The FDA reviews the submitted literature and its interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. There was no new "test set" created that would require an adjudication method. The clinical literature review inherently relies on the adjudication and peer-review processes of the original studies it incorporates.

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

This is not applicable. This device is an intervertebral body fusion system, not an AI software/medical imaging device. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or described.

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

This is not applicable. This device is a physical implant, not an algorithm, so standalone performance is not relevant in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the safety and effectiveness for the expanded indication is based on published clinical outcomes data and findings from the clinical literature review.

8. The sample size for the training set

This is not applicable. This is a 510(k) submission for a physical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set" as it relates to AI. The device's design and materials are based on established engineering principles and prior validated devices.

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

This is not applicable for the same reasons as point 8.

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