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The AlphaVent Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures:

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

Foot and Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair and Bunionectomy

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Cigament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or adjunct fixation for ACL/PCL Reconstruction or Repair

Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

The AlphaVent Suture Anchors are bone anchors with a screw-in design. Each anchor is vented and cannulated and is provided pre-loaded with one or more working sutures with or without needles. The working sutures run through the cannulated anchor body and are attached to the distal end of the anchor by an integrated suture loop, referred to as a "soft eyelet." The anchor with working sutures is provided pre-assembled on an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are provided sterile and are packaged in sterile barrier systems (SBS) that include one anchor pre-loaded with suture on an inserter.

This document describes the 510(k) premarket notification for Stryker's AlphaVent Suture Anchors, focusing on the substantial equivalence to predicate devices rather than the performance of an AI application or the direct demonstration of meeting specific performance acceptance criteria through a clinical validation study with defined endpoints.

Therefore, the requested information regarding acceptance criteria, study design for device performance (especially for AI), sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be provided from the given text. The document describes a traditional 510(k) submission based on modifications to an existing device and equivalence to predicates, not the de novo clearance of a novel device or AI/ML product where such detailed performance studies with acceptance criteria are typically required and reported.

The document primarily focuses on:

• Device Description: AlphaVent Suture Anchors, screw-in design, vented, cannulated, pre-loaded with sutures.
• Modifications: Introduction of absorbable "AlphaVent Biocomposite Suture Anchors" and expanded indications for use to include skeletally mature pediatric patients and additional surgical procedures (gluteal tendon repair, proximal hamstring repair).
• Comparison to Predicates: Demonstrated substantial equivalence to AlphaVent PEEK Suture Anchors (K211502) and Arthrex SwiveLock Anchors (K203495) based on intended use, operational principle, design, materials, sterilization, packaging, and performance attributes.
• Performance Data (Non-Clinical): Benchtop testing for Ultimate Tensile Strength (UTS) and insertion testing. For biocomposite anchors, UTS was also performed after in vitro degradation. Biocompatibility testing per ISO 10993-1:2018 and pyrogenicity/bacterial endotoxin testing were also conducted.

Based on the provided text, none of the requested information regarding acceptance criteria and the study proving the device meets those criteria (in the context of an AI/ML device) is available. The submission describes a traditional 510(k) for a modified mechanical device, not an AI/ML-driven diagnostic or therapeutic device.

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