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The ToeTac™ Hammertoe Fixation System indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The Instratek ToeTac™ Hammertoe Fixation System includes a threaded PEEK implant for bone fixation and a set of instruments used for implant site preparation and delivery. The device is offered in a sterile packaged kit that contains the implant, bone preparation instrumentation and a driver.

This document is a 510(k) premarket notification for the ToeTac™ Hammertoe Fixation System. It confirms that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices.

The document contains information about the device's intended use, classification, and a summary. However, it does not contain information regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in a comprehensive device validation report. Instead, it briefly mentions "Performance testing consisted of tests for axial pull out, torque, static and dynamic bend." without providing details of the acceptance criteria or quantitative results.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted:

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

   • Acceptance Criteria: Not explicitly stated in the document.
   • Reported Device Performance: The document only generally states, "Performance testing consisted of tests for axial pull out, torque, static and dynamic bend." No specific quantitative performance data or comparison to acceptance criteria is provided.

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

   • This information is not provided in the document.

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 information is not applicable as the document describes performance testing for a medical device (fixation system), not a diagnostic or AI-driven decision support system where "ground truth" would be established by experts for a test set.

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

   • This information is not applicable for mechanical performance testing of a fixation system.

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 information is not applicable as the device is a hammertoe fixation system, not an AI diagnostic tool.

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

   • This information is not applicable as the device is a hammertoe fixation system, not an AI algorithm.

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

   • For performance testing of a mechanical device, "ground truth" typically refers to engineering standards or predicate device performance, not clinical ground truth established by experts or pathology. Details are not provided.

8. The sample size for the training set

   • This information is not applicable as the device is a mechanical fixation system, not an AI model requiring a training set.

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

   • This information is not applicable as the device is a mechanical fixation system, not an AI model requiring a training set.

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