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The EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius and ulna.

The EVOLVE® EPS OTHOLOC™ System is extended to offer two longer screw lengths and four shorter plates. The driver-screw interface is also being modified. The plates are identical to the predicate in hole/slot placement and depth, plate shape and material. The subject screws have identical profile and thread form. The screws may be used with or without the plates.

The provided text indicates that the EVOLVE® EPS ORTHOLOC™ System is a bone plate and screw system, and the submission is for an extension of the existing system (K100146) to include longer screw lengths, shorter plates, and a modified driver-screw interface. The study performed is a non-clinical, mechanical study, not a clinical study involving human or animal subjects. Therefore, many of the requested categories are not applicable.

Here's the information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: Not explicitly stated in terms of number of screws/plates tested, but the study refers to "ultimate torque testing, pull-out data, and off-axis locking comparison." It's common in mechanical testing to test multiple samples to ensure repeatability and statistical significance, but the exact number isn't provided here.
• Data Provenance: The data is from non-clinical laboratory testing performed by Wright Medical Technology, Inc.

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 non-clinical, mechanical performance study. "Ground truth" in the context of expert review is not relevant for this type of testing. The acceptance criteria were based on predefined mechanical engineering standards and comparison to a predicate device.

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

• Not Applicable. As a non-clinical engineering study, an adjudication method for case evaluation is not relevant. The performance metrics (e.g., torque values, pull-out forces) were direct measurements.

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 mechanical device, not an AI or diagnostic imaging device. No MRMC study was conducted.

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

• Not Applicable. This is a mechanical device. No algorithm or standalone performance testing was performed.

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

• Not Applicable (or "Predicate Device Performance Data"). For this non-clinical study, the "ground truth" for comparison was the established mechanical performance of the predicate EVOLVE® EPS ORTHOLOC™ System (K100146) and relevant engineering standards for bone fixation devices. The goal was to demonstrate that the modified device performed "at least as well as" the predicate.

8. The sample size for the training set:

• Not Applicable. This documentation does not describe a machine learning algorithm, and thus there is no training set in that context. The "training" for such a device involves design and manufacturing processes, not data for an AI model.

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

• Not Applicable. No training set for an AI model was used.

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