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The ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intra- and extraarticular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization and fixation of fragments in fresh fractures.

ORTHOLOC™ 3Di Locking Screws are intended for use with Wright's ORTHOLOC 3Di Plating Systems of the same base material.

ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, ostectorny, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

The subject ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is designed to facilitate fracture fixation of the fibula and tibia. The system achieves its intended effect through the use of the various titanium alloy (Type II Anodized) straight, anatomical, and contoured plates and both locking and non-locking screws.

This document, a 510(k) Premarket Notification from the FDA, pertains to a medical device: the "ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System". It describes the device, its intended use, and comparative testing performed to demonstrate substantial equivalence to predicate devices, but does not involve an AI/ML component. Therefore, most of the requested information regarding AI/ML acceptance criteria and study details (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

The document discusses non-clinical evidence to support substantial equivalence, primarily mechanical testing and engineering justification. It explicitly states "N/A" for clinical evidence.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not:

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

The document does not provide a table of acceptance criteria in the context of an AI/ML model's performance. Instead, it describes mechanical testing conducted to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" here are implicitly meeting the performance of the predicate device.

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

This information is not applicable as the document describes non-clinical mechanical testing, not a study involving patient data for an AI/ML model. The "test set" in this context refers to the physical devices undergoing mechanical stress tests. The document does not specify the number of devices tested, but rather the standards followed (ASTM F382, ASTM F2182).

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)

This is not applicable. There is no "ground truth" established by experts in the context of mechanical testing. The results are based on objective physical measurements and engineering evaluations.

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

This is not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert consensus for labeling data, which is not present here.

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

This is not applicable. This document does not describe the evaluation of an AI-assisted device. There were no human readers whose performance was being assessed.

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

This is not applicable. This document does not describe an algorithm or AI model.

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

This is not applicable. The "ground truth" for this device's evaluation relies on established engineering standards and physical properties, not clinical or pathological outcomes.

8. The sample size for the training set

This is not applicable. There is no AI/ML model described in this document, and therefore no training set.

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

This is not applicable. No training set or associated ground truth establishment process is relevant to this device's submission.

In summary: The provided FDA document is a 510(k) for a traditional medical device (bone fixation plates and screws). It demonstrates substantial equivalence through mechanical and engineering testing, not through clinical or AI/ML performance studies. Therefore, most of your questions, which are highly relevant to AI/ML device evaluations, are not addressed by this document.

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