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The G-FORCE® Suture Anchor System is indicated for use:

• In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
• In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
• In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament:
• In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
• In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.

The G-FORCE® Ti Suture Anchor System is a sterile, single-use, hand-held device intended to aid in the attachment of soft tissue to bone. The G-FORCE® Ti Suture Anchor System comes preloaded with non-absorbable polyethylene-based sutures, needles and titanium alloy anchors. The anchors are available in a variety of sizes with correspondingly sized suture.

The provided text is a 510(k) summary for the G-FORCE® Ti Suture Anchor System. This document describes a medical device, its intended use, and its substantial equivalence to a predicate device. It is a regulatory submission for a physical medical device (suture anchor system) and primarily relies on bench testing for performance demonstration.

Therefore, the requested information regarding acceptance criteria for an AI/ML device, studies proving it meets those criteria, sample sizes for training/test sets, ground truth establishment, expert involvement, and MRMC studies, is not applicable to this document.

The document explicitly states:

• "Bench testing was used to demonstrate that the torque and tensile strength characteristics of the G-FORCE® Ti Suture Anchor System are safe and effective."

This indicates that the performance evaluation was based on physical testing of the device's mechanical properties, not on AI/ML algorithm performance on data.

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