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-Stryker Universal SMARTLock Hybrid MMF System: The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
-Universal CMF System: Craniomaxillofacial Implants The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Mandible Implants The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.
-Stryker MMF screw: The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.

The Subject Device screws are screw versions modified with the Stryker AXS Screw technology, where the abbreviation "AXS" stands for axial stability. This submission is adding the AXS Screw technology to the Subject Device. The Subject Device screws have modified geometry and features which will be implemented as AXS Screws in each of the existing Predicate/Reference Device systems. This includes screws with a length range of 4-20 mm and a diameter range from 2.0-2.7 mm. The materials (titanium and stainless steel) are the same as for the corresponding Predicate/Reference Devices. There are no other changes to the Predicate/Reference Device systems, only the implementation of the AXS Screw technology to each existing product line. The Subject Device screws will have the same clinical application, treat the same craniomaxillofacial anatomical locations, and are for the same patient population as the corresponding Predicate/Reference Devices.

The provided FDA 510(k) clearance letter pertains to Stryker MP, Mandible, HMMF and MMF AXS Screws, which are intraosseous fixation screws. This submission is for a medical device (screws), not an AI/software as a medical device (SaMD). Therefore, the questions related to AI device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.

The clearance is based on demonstrating substantial equivalence to predicate devices, primarily through engineering performance bench testing.

Here's the relevant information that can be extracted from the document:

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

The document states that "The Subject Device met all pre-defined acceptance criteria, and the results of the V&V tests support the substantial equivalence of the Subject Device to the Predicate/Reference Devices." However, the specific numerical acceptance criteria for each test are not detailed in this summary document. The document lists the types of performance bench tests conducted:

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

This information is not provided in the summary document. The document refers to "Verification and Validation (V&V) testing" and "test reports" being included within the full submission, but the summary itself does not detail specific sample sizes for these bench tests or the provenance of any data beyond the general statement that testing was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a medical device (screws) and does not involve AI or software requiring expert review for ground truth establishment. The "acceptance criteria" are engineering performance metrics.

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

Not Applicable. This is a medical device (screws) and does not involve subjective human interpretation or adjudication for its performance evaluation in the way an AI diagnostic tool would. Performance is based on objective engineering tests.

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 medical device (screws) and does not involve AI or human "readers."

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

Not Applicable. This is a medical device (screws) and does not involve an algorithm.

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

For mechanical performance tests, the "ground truth" or reference standard would be the physical properties and behavior of the devices as measured by standardized testing methods (e.g., ASTM F543) and compared against pre-defined engineering specifications and the performance of the predicate device.

8. The sample size for the training set

Not Applicable. This is a medical device (screws) and does not involve a training set as would be used for AI/machine learning.

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

Not Applicable. This is a medical device (screws) and does not involve a training set.

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