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The GRAPPLER Suture Anchor System is intended for the fixation of soft tissue to bone including:

Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC

Foot/Ankle: Lateral Stabilization (Brostrom, Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair

Hip: Capsular Repair, Acetabular Labral Repair

The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.

The GRAPPLER Suture Anchor System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in PEEK, titanium, and suture materials in multiple sizes and lengths. Each anchor is accompanied by round suture or suture tape composed of UHMWPE and PGLA.

The provided text appears to be an FDA 510(k) summary for a medical device called the "GRAPPLER Suture Anchor System." It outlines the device's intended use, description, and the performance testing conducted to demonstrate its substantial equivalence to a predicate device.

However, the provided document does not contain information about an AI/ML-based device or a study proving its performance against acceptance criteria in the context of AI/ML. It focuses on a mechanical medical device (suture anchor system) and its physical and mechanical properties.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-based device, a comparative effectiveness study with human readers, or details regarding training/test sets for an AI model, as this information is not present in the provided text.

The document discusses performance testing for a physical device, which includes:

• Torsional Yield per ASTM F543
• Insertion and Removal Torque per ASTM F543
• Pullout Strength per ASTM F543
• Analysis for Suture Abrasion
• USP Monograph (including USP <861> and USP <881>)
• Suture Tape Relaxation Evaluation
• Fatigue Testing according to FDA Guidance Bone Anchors - Premarket Notification (510(k)) Submissions
• Device shelf life validation (seal strength, visual inspection, dye penetration, pressurization evaluations)
• Device sterility validation (bioburden testing)
• Pyrogenicity verification (bacterial endotoxin (LAL) testing)

The document states that "All performance testing conducted for the GRAPPLER Suture Anchor System met the predetermined acceptance criteria or were otherwise considered acceptable." However, it does not detail what those specific numerical acceptance criteria were for each test.

To summarize, based solely on the provided text, I cannot answer your request as it pertains to an AI/ML device. The document describes a traditional medical device submission.

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