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The Aevumed RAPID™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hip: Capsular repair, Acetabular Labral Repair

The Aevumed RAPIDTM Suture Anchor with HS FiberTM suture is a suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed RAPIDTM Suture Anchors are available in diameter sizes: 2.4mm and 3.0mm. They are offered sterile and are for single use only

The provided text is a 510(k) premarket notification for a medical device (Aevumed RAPID™ Suture Anchors). It details the device's characteristics, indications for use, and a comparison to predicate devices, but does not describe a study involving AI or software, nor does it provide acceptance criteria and performance data in the context of an AI/software device evaluation.

Therefore, I cannot extract the information required in your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because the document describes a hardware medical device (suture anchors) and its mechanical testing, not a diagnostic or AI-driven system.

The "Non-clinical Tests" section mentions mechanical testing for pullout strength and states:

• Study: "Both the Aevumed RAPID™ Suture Anchor and predicate SutureTak™ Anchor (K140855) were mechanically tested for maximum pullout strength."
• Result: "The Aevumed RAPID™ Suture Anchor demonstrated significantly higher pullout strength in comparison to the predicate SutureTak™ Anchor (K140855)."

This is the only "performance" information related to a "study" in the document, and it pertains to the physical device's mechanical properties, not an algorithmic performance.

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