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Shoulder (bankart repair), Hand (ulnar or lateral collateral ligament reconstruction), Wrist (scapholunate ligament reconstruction), Foot (hallux valgus reconstruction), and Ankle (midfoot reconstructions)

Made from surgical grade stainless steel (316L), the LM Anchor is designed with a crown and a center pin through which suture is passed to provide a means for soft tissue to bone attachment.

This document is a 510(k) summary for a medical device (LM Anchor) and does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as typically found in submissions for AI/ML-driven imaging or diagnostic devices.

The provided text describes a bone anchor and its pre-clinical testing, which focuses on mechanical performance (pullout strength). It lacks any mention of:

• Acceptance criteria (quantitative metrics like sensitivity, specificity, AUC)
• Studies involving test sets, ground truth, experts, or comparative effectiveness with AI.
• Training sets or how their ground truth was established.
• Any AI or machine learning component.

The "Performance Data" section simply states: "Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the Mitek Mini Anchor." This is a comparison of mechanical properties, not diagnostic or interpretive performance.

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