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The Nextra™ Ti Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

The Nextremity Solutions Nextra™ Ti Hammertoe Correction (Nextra) System consists of proximal and distal components provided as a set with the necessary surgical site preparation and insertion instruments in a procedure pack. Nextra is fabricated from medical grade titanium alloy (6Al-4V) and the design allows the clinician to establish a natural angulation of the fused interdigital joint.

The provided text describes mechanical testing for the Nextra™ Ti Hammertoe Correction System. However, it does not include the specific acceptance criteria or detailed results of that testing. It simply states that "Mechanical testing was performed as described in relevant recognized standards, including testing for pull-out force, driving torque, torque to failure, static and dynamic flexion extension resistance."

Therefore, based on the provided input, I cannot answer most of your questions as the necessary information is not present.

Here's what I can provide based on the given 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 in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). This was mechanical testing, so "provenance" might refer to the lab conducting the tests.

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-established ground truth.

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

• Not applicable. This was mechanical testing of a bone fixation device, not an AI-assisted diagnostic tool or an MRMC study.

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

• Not applicable. This was mechanical testing of a bone fixation device, not an algorithm.

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

• Not applicable in the conventional sense for mechanical testing. The "ground truth" would be the engineering specifications and recognized testing standards (e.g., ISO, ASTM) against which the device's mechanical properties are measured.

8. The sample size for the training set

• Not applicable. This was mechanical testing, not a machine learning study with a training set.

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

• Not applicable. This was mechanical testing, not a machine learning study.

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