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The MONET Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The MONET Anterior Cervical Plate System is intended to be used as an adjunct to fusion with either the MONET ACIF Cage System or structural allograft or any FDA-cleared Cervical Cage System.

The MONET Anterior Cervical Plate System is an anterior cervical fixation device used to provide structural stability in skeletally mature individuals. The system is comprised of plates, screws and instruments to facilitate the installation of the implants.The plates are available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

The provided document is a 510(k) summary for the MONET Anterior Cervical Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical testing. However, it does not provide specific acceptance criteria or an explicit study that proves the device meets detailed performance criteria in the format requested.

The document states: "Results of the non-clinical tests indicate that no new issues of safety and effectiveness have been raised." This is a general statement about the outcome of the comparison to predicate devices, rather than a detailed report of adherence to specific numerical acceptance criteria.

Therefore, I cannot provide the detailed information requested in the table and subsequent questions based on the provided text. The document focuses on demonstrating substantial equivalence through similar intended use, indications, materials, design features, and sterilization methods, supported by types of non-clinical tests rather than specific performance metrics and their corresponding acceptance thresholds.

Here's what I can extract regarding the performance testing, though it lacks the specific detail asked for:

Summary of Performance Data (Nonclinical and/or Clinical):

• Non-Clinical Tests:
  • Static Compression Bending (per ASTM F1717)
  • Static Torsion (per ASTM F1717)
  • Dynamic Compression Bending (per ASTM F1717)
• Clinical Tests:
  • N/A (No clinical tests were performed for this submission)

Regarding the specific questions asked, based only on the provided text:

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

   • Cannot be provided. The document lists the types of tests performed (Static Compression Bending, Static Torsion, Dynamic Compression Bending, all per ASTM F1717) but does not provide specific numerical acceptance criteria or the reported performance data for the MONET Anterior Cervical Plate System. It only states that the "results of the non-clinical tests indicate that no new issues of safety and effectiveness have been raised," implying it met the criteria for substantial equivalence to the predicate devices.

2. Sample sizes used for the test set and the data provenance:

   • Cannot be provided. The document does not specify sample sizes for the non-clinical tests, nor does it provide data provenance details like country of origin or whether the data was retrospective or prospective.

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

   • N/A. This question is usually relevant for studies involving human interpretation (e.g., medical imaging). The tests performed were non-clinical mechanical tests, not involving expert interpretation of "ground truth" in that sense.

4. Adjudication method for the test set:

   • N/A. This is not applicable to the non-clinical mechanical tests described.

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:

   • N/A. This device is a physical spinal implant, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

   • N/A. This device is a physical spinal implant, not an algorithm.

7. The type of ground truth used:

   • For the non-clinical mechanical tests, the "ground truth" would be established by the engineering specifications and requirements outlined in ASTM F1717, which dictate how mechanical properties should be measured and what performance characteristics are expected for such devices. The document does not specify these values.

8. The sample size for the training set:

   • N/A. This is not relevant for a physical medical device undergoing mechanical testing. There is no "training set" in the context of device approval for this type of product.

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

   • N/A. As no training set is relevant, this question is not applicable.

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