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The PMT Facet Screw is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The PMT Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1. The PMT Facet Screw is indicated for treatment of any or all of the following:

1. Pseudoarthrosis and failed previous fusion
2. Spondylolisthesis
3. Spondylolysis
4. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
5. Degeneration of the facets with instability; and
6. Fracture
   The PMT Facet Screw is intended for conventional or tissue-sparing surgical placement.

The PMT Facet Screw is available in fully threaded configurations with diameters of 3.5 mm, 3.75 mm and 4.0 mm and lengths of 13 mm to 25 mm (in 2 mm increments). The PMT Facet Screw is constructed of Titanium-6 Aluminum- 4 Vanadium ELI alloy (conforming to ASTM F136-13) and supplied sterile for single use only.

The provided text describes the 510(k) summary for the PMT Facet Screw and details the performance testing conducted to demonstrate its substantial equivalence to predicate devices. It does not describe an AI/ML powered device, but rather a medical implant. As such, information regarding AI/ML-specific acceptance criteria, the study proving the device meets those criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable or available in this document.

However, based on the provided text, I can extract information relevant to the non-AI device's performance testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "In all instances, the PMT Facet Screw functioned as intended and met all pre-determined acceptance criteria and do not raise new issues of safety or effectiveness; thus demonstrating that the PMT Screw is substantially equivalent to the legally marketed predicate device."

While specific numerical acceptance criteria for each test (e.g., minimum bending strength, torque values) are not explicitly detailed in the provided text, the successful completion of the tests against established ASTM standards and FDA guidance implicitly defines these criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample sizes used for each of the mechanical performance tests (e.g., number of screws tested for bending, torsion, pull-out, or drive torque). It also does not mention data provenance as these are laboratory-based physical tests, not clinical data.

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

Not applicable. The "ground truth" for the performance testing of this medical device is based on established engineering standards (ASTM) and regulatory guidance, not expert interpretation of clinical data in the traditional sense. These tests are objective measurements of physical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human adjudication of results, but rather objective mechanical and biological compatibility testing against predefined specifications.

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 device is a surgical implant, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant here.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance tests are the specifications and requirements defined by the referenced ASTM standards (F2193-14, F543-17) and FDA guidance documents for sterility and pyrogenicity. These are objective engineering and biological safety criteria.

8. The sample size for the training set:

Not applicable. There is no training set for a non-AI mechanical device.

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

Not applicable. There is no training set for a non-AI mechanical device.

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