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The NuVasive CoRoent Small Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The NuVasive CoRoent Small Interbody System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion.

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 autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material 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 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 purpose of this 510(k) is to expand the indications for use to include the treatment of multilevel cervical disc degeneration and/or cervical instability at up to four contiguous levels.

The provided text describes a 510(k) premarket notification for a medical device called the NuVasive® CoRoent® Small Interbody System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data from a retrospective clinical study and clinical literature analysis.

However, the document does not contain the following information typically found in a study proving a device meets specific acceptance criteria, especially for AI/ML-based medical devices:

• A table of acceptance criteria and reported device performance: This document doesn't define quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, precision, recall) or provide numerical results for such metrics.
• Sample size used for the test set and data provenance: While a "retrospective clinical study" is mentioned, details about the test set size or data provenance (country of origin, specific demographics) are not provided.
• Number of experts used to establish ground truth and their qualifications: No information is given about expert involvement in establishing ground truth.
• Adjudication method: There is no mention of an adjudication process.
• MRMC comparative effectiveness study: This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
• Standalone performance: The text describes a "clinical study" and "clinical literature analysis" to support safety and effectiveness, but it doesn't present performance as a standalone algorithm in the way an AI/ML device would.
• Type of ground truth used: The clinical data determined safety and effectiveness for cervical disc degeneration, but the specific method of establishing "ground truth" (e.g., pathology, long-term outcomes, expert consensus on imaging) is not detailed.
• Sample size for the training set: This is not an AI/ML device, so a "training set" in that context is not relevant and not mentioned.
• How ground truth for the training set was established: Again, not applicable for this type of device.

What the document does state and imply:

The document describes the NuVasive® CoRoent® Small Interbody System and its intended use for intervertebral body fusion.
The primary purpose of this 510(k) is to expand the indications for use to include the treatment of multilevel cervical disc degeneration and/or cervical instability at up to four contiguous levels.

F. Technological Characteristics:

• Subject device: PEEK-Optima® LT-1 hollow interbody cage with a graft aperture, teeth to resist migration, and radiopaque marker pins (titanium alloy or tantalum).
• Substantial equivalence: The device is considered substantially equivalent to other predicate devices cleared by the FDA, including the primary predicate NuVasive CoRoent Small Interbody System (K150362). The equivalence is based on similar design, intended use, material composition, and function.
• No software or electrical equipment: This confirms it's not an AI/ML device.

G. Performance Data:

• Study Design: A retrospective clinical study was conducted.
• Study Population: Patients with cervical spondylosis including cervical disc degeneration, herniated nucleus pulposus (HNP), stenosis, deformity, and/or instability were treated with the subject device.
• Findings: "Based on the clinical data, it was determined that the CoRoent Small Interbody System used in the treatment of 3- and 4-level cervical disc degeneration has a safety and effectiveness profile similar to the predicate device."
• Supplementary Data: A clinical literature analysis of multilevel anterior cervical discectomy and fusion (ACDF) was performed to support the use of the subject device at 3 and 4 cervical levels.
• No new nonclinical testing: No new nonclinical testing was performed because no other changes were made to the interbodies since their previous clearance.

In summary, as this is a traditional medical device (not AI/ML), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of demonstrating substantial equivalence to a predicate device for an expanded indication for use. The key "proof" is that the retrospective clinical study and literature review showed a similar safety and effectiveness profile for the expanded indications compared to the previously cleared predicate device.

The document does not provide the specific quantitative performance metrics (like sensitivity, specificity, etc.) or detailed methodological breakdowns characteristic of AI/ML device evaluations.

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