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The Arthrex Corkscrew FT Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis.

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

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

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

The Arthrex Corkscrew FT with a suture eyelet molded or internally fixed and a fully threaded body, are 4.5 mm to 6.5 mm in diameter and are offered on a driver.

The provided text is a 510(k) summary for the Arthrex Corkscrew FT. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as such studies are typically not required for 510(k) submissions that rely on substantial equivalence.

510(k) submissions primarily focus on comparing the new device to a predicate device and demonstrating that any differences do not raise new questions of safety or effectiveness. Therefore, the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for the Arthrex Corkscrew FT is not present in this document.

The document states:
"The Arthrex Corkscrew FT, 4.5 mm and 6.5 mm are substantially equivalent to the predicate Arthrex Bio-Corriscrew FT, 5.5 mm in which the basic features and intended uses are the same. Any differences between the Arthrex 4.5mm and 6.5mm and 6.5mm Corkscrew FT and the 5.5 mm Bio-Corkscrew FT predicate are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the Corkscrew FT ranging in size from 4.5 mm to 6.5 mm, in both PEEK and PLLA, is substantially equivalent to the currently marketed predicate device."

This statement is the core of a 510(k) submission, confirming that no new performance studies (of the type you are asking for) were necessary to establish safety and effectiveness for this device beyond comparing it to an already approved device.

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