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The Arthrex Opening Wedge Osteotomy System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies.

The Arthrex Opening Wedge Osteotomy System includes the following basic components: a guide system, osteotomes, a forked-wedge tool for opening the wedge, and a set of bone plates for maintaining the wedge opening. The osteotomy plates are made of surgical grade stainless steel.

This document is a 510(k) premarket notification for the Arthrex Opening Wedge Osteotomy System. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance.
• The number or qualifications of experts for ground truth.
• Adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• A standalone algorithm performance study.
• The type of ground truth used.
• The sample size for a training set.
• How ground truth for a training set was established.

This is a regulatory submission for a surgical instrument system, relying on the substantial equivalence pathway, which typically involves comparing the device's technical characteristics and intended use to an already legally marketed predicate device rather than conducting new performance studies against specific acceptance criteria like those found in AI/ML device submissions.

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