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The Additive Orthopaedics Hammertoe Correction System is indicated for fixation of fractures, and fusion of small bones in the foot and hand; where such fragments are not under tension or load-bearing.

The Additive Orthopaedics Hammertoe Correction System is a monoblock non-circular shaft implant that is cannulated and non-cannulated and incorporates barbs along its longitudinal axis. The system is provided with a drill designed for preparation of the implant site. The implant device, and the drill, are provided in a sterile procedure pack. The implant is intended for single use only and it is available in 0° and 10° configurations. The implant device is additively manufactured from medical grade titanium alloy (Ti-6A1-4V).

This document is a 510(k) premarket notification for a medical device (Additive Orthopaedics Hammertoe Correction System), not a study report or clinical trial. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria, especially for AI/ML-based devices.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo performance criteria with specific acceptance thresholds for a novel device.

However, based on the provided text, I can infer and extract some relevant information:

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

The document does not specify quantitative acceptance criteria in a table format, nor does it report specific performance metrics with numerical values in relation to such criteria. Instead, it states that "Mechanical testing was performed as described in relevant recognized standards, including testing for pull-out force, static and dynamic flexion extension resistance." It then concludes, "From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device."

This implies that the acceptance criterion for substantial equivalence was that the device's mechanical performance, as measured by standard tests, was comparable to or better than predicate devices. The reported device performance is summarized as meeting this comparability standard, rather than providing specific numerical results.

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

• Sample size for test set: Not explicitly stated. The document refers to "mechanical testing," which typically involves a set number of physical samples, but the exact number isn't provided.
• Data provenance: Not explicitly stated, but the testing would have been conducted on manufactured devices in a laboratory setting. This is not clinical data (retrospective or prospective from human patients) but rather engineering/mechanical test data.

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

This question is not applicable in this context. Mechanical testing of a bone fixation device does not involve human experts establishing ground truth in the same way an AI diagnostic tool would. The "ground truth" for mechanical testing is based on objective physical measurements according to established engineering standards.

4. Adjudication method for the test set:

Not applicable. There's no human interpretation or adjudication in the context of mechanical performance testing as described.

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 physical Hammertoe Correction System (implant), not an AI-assisted diagnostic or therapeutic tool for "human readers."

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For mechanical testing, the "ground truth" would be the objective physical measurements obtained during the tests (e.g., actual pull-out force values, flexion/extension resistance) against established engineering standards and comparative data from predicate devices. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

Not applicable. This is a physical device undergoing mechanical testing, not an AI/ML system requiring a training set.

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

Not applicable. This is a physical device, not an AI/ML system.

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