Search Results

The SpiraLok Anchor is intended for: Shoulder: Rotor Cuff Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The SpiraLok Anchor is a PLA threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of two strands of suture to bone. Ethibond non-absorbable suture, the Panacryl absorbable suture and the Orthocord composite suture options may include tapered needles to facilitate suture passage through tissue. The attached suture is then used to reattach soft tissue back to bone where it reconnects through the healing process.

This looks like a 510(k) summary for a medical device called the SpiraLok Anchor. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in an AI/ML medical device submission.

The submission document focuses on demonstrating substantial equivalence through a "detailed device description" and "non-clinical laboratory testing" which showed the device is "safe and can be considered substantially equivalent to the predicate Arthrex Bio-Corkscrew Suture Anchor for the proposed new intended uses."

Therefore, it is not possible to provide the requested information based on the provided text. The prompt's specific requirements (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are characteristic of AI/ML software performance studies, which are not relevant to this type of device (a physical suture anchor).

Ask a specific question about this device