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The Omnia Medical Coupler-C Anterior Cervical Plate is indicated for use in temporarily stabilizing the anterior spine from C2 to T1 during the development of cervical spinal fusion in patients with degenerative disc disease (DD), neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities (i.e., scoliosis, kyphosis, and/or lordosis), tumors, pseudoarthrosis, or failed previous fusion.

The Omnia Medical Coupler-C Anterior Cervical Plate system includes plates, screws, and an instrument set used to insert the implants. The implants are composed of Ti-6Al-4V ELI per ASTM F136. The screws are inserted into the vertebral body through corresponding holes in the plate to achieve fixation. A screw locking system is incorporated in the plate, allowing the surgeon to lock screws into place with anti-backout mechanisms after insertion. The plates are available in multiple lengths and levels to allow for utilization in fusion operations across 1 to 4 levels of the cervical spine. The system instrumentation is manufactured from surgical grade stainless steel (17-4 PH per ASTM F899) and other surgical grade materials. The instrumentation is used to prepare the site and to implant the device.

This is a 510(k) premarket notification for a medical device, the Omnia Medical Coupler-C Anterior Cervical Plate. This document primarily focuses on establishing "substantial equivalence" of the new device to existing legally marketed predicate devices, rather than a diagnostic device that requires clinical performance studies based on acceptance criteria for accuracy metrics.

Therefore, the provided text does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the performance of a diagnostic or AI-powered device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical testing which demonstrates the device's physical properties are comparable to legally marketed predicate devices.

Here's the relevant information that can be extracted:

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

The document states:
"Substantial equivalence is supported by the results of mechanical testing, including static and dynamic compression bending, and static torsion per ASTM F1717. Results support that the subject device has demonstrated substantial equivalence."

Acceptance Criteria: Demonstrated "substantial equivalence" based on mechanical testing according to ASTM F1717 guidelines. (The specific numerical criteria for static and dynamic compression bending, and static torsion are not detailed in this document but would be defined by ASTM F1717 and the comparison to predicate devices.)

Reported Device Performance:

• Static and dynamic compression bending per ASTM F1717: Results support "substantial equivalence."
• Static torsion per ASTM F1717: Results support "substantial equivalence."

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical units of the device subjected to mechanical testing, not a dataset of patient images or clinical data. The provenance of these physical samples is not specified but would typically be manufactured units of the Omnia Medical Coupler-C Anterior Cervical Plate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic device is not relevant for this type of mechanical testing.

4. Adjudication method for the test set: 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. This is a spinal implant device, not a diagnostic imaging device with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used: Not applicable. For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices.

8. The sample size for the training set: Not applicable. This is not a machine learning or diagnostic device.

9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical device (a spinal implant), not a software or diagnostic device. Therefore, the questions related to acceptance criteria for diagnostic accuracy, study design for clinical performance, expert adjudication, or AI performance are not relevant to this specific K223321 submission. The "acceptance criteria" and "study" refer to mechanical testing validating the structural integrity and performance compared to existing devices.

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