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The Anterior Cervical Plate System is indicated for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications; degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Anterior Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter-length combination. Plates are available in a variety of lengths.

This document is a 510(k) premarket notification for a medical device called the Anterior Cervical Plate System. It is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding AI/algorithm performance, detailed study design, and expert review is not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. This was a bench testing study, not a clinical study with patient data. The "sample size" would refer to the number of physical constructs tested, but this specific number is not provided, only that the "worst case" construct was tested.
• Data Provenance: Not applicable. This refers to bench test results in a lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This was a mechanical bench test against a standard, not a study requiring expert clinical ground truth.

4. Adjudication method for the test set

• Not applicable. No clinical test set to adjudicate.

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 not an AI/algorithm-driven device. It is a physical implant.

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

• Not applicable. This is not an AI/algorithm-driven device.

7. The type of ground truth used

• Mechanical Performance Standards: The ground truth for performance was established by recognized mechanical testing standards (ASTM F1717) and comparison to the predicate device's established performance.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-driven device. There is no "training set."

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

• Not applicable.

Summary of the Study:

The study proving the device meets the acceptance criteria was a bench testing study. The purpose of this study was to demonstrate substantial equivalence of the Anterior Cervical Plate System to a legally marketed predicate device (Synthes Anterior CSLP System, K030866).

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion was that the mechanical performance of the subject device, when tested according to ASTM F1717 (covering static compression bending, torsion, and dynamic compression bending), would be comparable or equivalent to the predicate device.
• Device Performance: The study reported that "The mechanical test results demonstrated that the Subject device is substantially equivalent to the predicate devices."
• Test Conduct: The testing was performed on the "worst case Anterior Cervical Plate construct."
• Ground Truth: The "ground truth" for the mechanical performance comparison was the established performance characteristics of the predicate device and the requirements of the ASTM F1717 standard.
• Purpose: The overall conclusion was that the Anterior Cervical Plate System has the same intended use, identical indications for use, similar technological characteristics and materials as its predicate(s), and minor differences do not raise new safety or efficacy concerns after bench testing.

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