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Intended Use: Reattachment of soft tissue to bone

Indications for Use :

1. Bankart Lesion Repair
2. Rotator Cuff Repair
3. Capsular Stabilization
4. Anterior Shoulder Instability Repair
5. Repair of ligaments and tendons of the elbow, foot, and ankle including the treatment of:

• Bunionectomy -
• Lateral ankle instability -
• Biceps tendon reattachment -

The Tag Rod BioRaptor 2.9 mm suture anchor is a push-in bioabsorable device utilized for the reattachment of soft tissue to bone.

This document is a 510(k) summary for a medical device (Tag Rod BioRaptor™ Suture Anchor) and does not contain information about acceptance criteria or a study demonstrating the device meets those criteria.

This type of submission focuses on demonstrating substantial equivalence to a previously approved predicate device, rather than proving performance against specific acceptance criteria through a clinical or performance study.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text. This information is typically found in a clinical study report or a more detailed device performance evaluation, neither of which is present here.

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