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The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.

AI/ML Overview

This FDA 510(k) summary describes a modification to an existing medical device, the Flex-Thread™ Distal Fibula Intramedullary Nail System, rather than the initial clearance of a novel AI/Ml medical device. Therefore, the information typically requested regarding acceptance criteria, study design for AI performance, sample sizes, and ground truth establishment, as it pertains to AI algorithms, is not applicable in this context.

The submission is a Special 510(k) to introduce a larger diameter nail (5.5mm) and an additional end cap (1mm) to an already cleared system. The focus of the provided text is on demonstrating the substantial equivalence of these mechanical modifications to the predicate device, not on the performance of a software algorithm.

Here's a breakdown of why this information is not present and what was done instead:

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

Not Applicable. This document does not describe performance metrics for an AI algorithm. Instead, it states that "Mechanical testing was performed on the modified Flex-Thread™ Distal Fibula Intramedullary Nail System using the same protocols as those used to verify the Flex-Thread™ Distal Fibula Intramedullary Nail System design as part of K202858." The tests included "Tip Reaction Force, Insertion Torque, and Simulated Use Cadaver Lab." The conclusion is that "The results design inputs meet design outputs and substantial equivalence of the subject device to the predicate." This implies that the acceptance criteria were met for these mechanical tests, but specific quantitative acceptance criteria or detailed results are not provided in this summary.

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

Not Applicable. This refers to sample sizes for mechanical testing (e.g., number of nails tested, number of cadavers). The document mentions "Simulated Use Cadaver Lab" but does not specify the number of cadavers or the origin of the cadaveric material.

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 is relevant for AI image analysis or diagnostic devices. No expert review for ground truth is described for this mechanical device modification.

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

Not Applicable. This pertains to expert review in AI studies.

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 is specifically for AI-assisted diagnostic devices.

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

Not Applicable. This is for AI algorithm performance.

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

Not Applicable. Ground truth for AI algorithms. For a mechanical device, performance is evaluated against engineering specifications and biomechanical principles.

8. The sample size for the training set:

Not Applicable. No AI model training is described.

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

Not Applicable. No AI model training is described.

In summary, the provided document is a regulatory submission for a modification to a mechanical orthopedic implant, not an AI/ML medical device. Therefore, questions related to AI algorithm performance, training, and ground truth are not relevant to this content.

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