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The Osprey Suture Anchor is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, and elbow in the following procedures:

• Shoulder: Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair.

• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot reconstruction, Metatarsal Ligament Repair, Bunionectomy.

• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Meniscal Root Repair. Secondary fixation for ACL/PCL reconstruction.

• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

The Osprey Suture Anchor is an anchor device comprised of polyether ether ketone (PEEK) material that is designed for the fixation of soft tissue to bone. The device creates a secure point for the fixation of soft tissue to bone when inserted through a pilot hole and deployed within bone. The system features a knotless 5.35mm diameter suture anchor preloaded on an inserter with two suture pull tabs. The system also includes two 2.3mm repair suture tapes and an auxiliary #0 suture that holds the anchor in place on the inserter until use and is then discarded. The Osprey system is designed to be used with manual surgical instruments including a 2.4mm guide drill, a 5.0mm cannulated drill, and a suture passer to aid in device placement. The Osprey Suture Anchor is pre-loaded on disposable inserters and provided to the end user sterile via ethylene oxide (EO) sterilization, while the reusable instruments (drills and suture passer) are non-sterile and are intended to be sterilized by the end user. The Responsive Arthroscopy Osprey Suture anchors and instrumentation are designed to accommodate an arthroscopic surgical approach.

I am sorry, but the provided text does not contain information about acceptance criteria and device performance in the format of a table or details of a study that proves the device meets specific criteria.

The document is a 510(k) summary for a medical device called the "Osprey Suture Anchor." It discusses the device's indications for use, technological characteristics, and a comparison to predicate devices to establish substantial equivalence. While it mentions "performance testing" and "bench testing" that "met acceptance criteria," it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Details of multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details of standalone performance studies (algorithm-only).
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and general performance testing, rather than reporting specific quantitative acceptance criteria and their fulfillment.

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