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The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

• . Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• . Trauma (including fractures)
• . Tumors
• . Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• . Pseudoarthrosis
• . Failed previous fusion
• . Spondylolisthesis
• Spinal Stenosis
  THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS
  WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE

The REGENT Anterior Cervical Plate System is composed of various cervical plates and the screws in made from a Titanium alloy (Ti-6Al-V, ASTM F-136/ISO 5832-3). The REGENT Anterior Cervical System contains multiple level plates (1 Level, 3 Level, and 4 Level) and various diameter screws that are either fixed or variable in nature. The plates and screws are anodized.

The provided text describes a medical device, the REGENT Anterior Cervical Plate System, and its regulatory submission. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a clinical or standalone study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/device performance study is not available in the provided text.

The document explicitly states "Clinical Testing Not Applicable" and "Animal Testing Not Applicable," indicating that the submission primarily relied on bench testing and comparison to predicate devices for substantial equivalence.

Here's what can be extracted from the text in relation to your request, but with the understanding that it doesn't align with a typical AI device performance evaluation:

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

Note: The "acceptance criteria" here are inferred from the mention of ASTM F 1717-04 and the substantial equivalence claim. Actual specified criteria are not provided in detail.

2. Sample sized used for the test set and the data provenance:
Not applicable. No test set for device performance as per an AI study is mentioned. The submission refers to "Bench Testing" data, but details about sample size or data provenance for these bench tests are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is discussed in the context of an AI/device performance study.

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:
No. The document states "Clinical Testing Not Applicable."

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

7. The type of ground truth used:
For the bench testing, the "ground truth" would be the engineered specifications and performance standards defined by ASTM F 1717-04.

8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device.

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

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