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The Smart Toe II is indicated for interphalangeal fusion of the toes.
The X Fuse is indicated for interphalangeal fusion of fingers and toes.

The Smart Toe II & X Fuse, previously cleared in K112179, are threaded metallic bone fixation fasteners and include superelastic and body temperature activated shape memory Nitinol per ASTM F2063-18. The subject of the bundled submission introduces a new passivation step and packaging change.

I am sorry. The provided FDA submission document is a 510(k) summary for a medical device (Smart Toe II & X Fuse) and primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing. It explicitly states that clinical testing was not required for this submission.

Therefore, I cannot provide information on acceptance criteria, reported device performance from a clinical study, sample sizes for test sets (as there was no clinical test set), expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document describes non-clinical testing for mechanical performance and corrosion testing. The acceptance criteria for these non-clinical tests would typically be a demonstration of equivalence or superiority to the predicate device, but these specific criteria and numerical results are not detailed in the provided summary.

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