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The Hoffmann® II Micro External Fixation System is an intended to be used with the Half Pins or Transfixing Pins of the Hoffinann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

This Special 510(k) submission is intended to address modifications to the predicate Hoffmann® II Micro "External Fixation System. The subject and predicate Hoffmann® II Micro" External Fixation Systems are both fabricated from stainless steel components and carbon connecting rods.

The provided text describes a Special 510(k) submission for the Hoffmann® II Micro™ External Fixation System Line Extension. This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not contain information about clinical studies with human participants, expert review, or AI algorithms. Therefore, many of the requested sections about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance, reader studies, and ground truth cannot be extracted from this specific document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

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

• Sample Size: Not specified for the mechanical testing.
• Data Provenance: Not applicable. The "study" referenced is mechanical testing, not a clinical data study.

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 was mechanical testing, not a study requiring expert consensus or ground truth in the medical diagnostic sense.

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

• Not applicable. This was mechanical testing.

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

• No. This document does not pertain to AI or human reader studies.

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

• No. This document is about a mechanical external fixation system, not an algorithm.

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

• For the mechanical testing: The "ground truth" was compliance with established engineering performance standards, as demonstrated by the predicate device's mechanical properties.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm requiring a training set.

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

• Not applicable. This device is not an AI algorithm.

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