(28 days)
The Arthrex Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in 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/Tendon Repair, Bunionectomy.
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
• Hip: Capsular Repair, acetabular labral repair.
The Arthrex 3.9mm Corkscrew is a partially threaded suture anchor pre-loaded with Arthrex Suture on a disposable inserter. The anchor is manufactured from either PLLA/BTCP or PEEK and is offered sterile, single use.
The provided document is a 510(k) summary for a medical device (Arthrex 3.9mm Corkscrew Suture Anchor) and does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance. Instead, it describes:
- Device Description and Intended Use: The device is a suture anchor used for soft tissue fixation to bone in various anatomical locations and procedures.
- Comparison to Predicate Device: The submission is a line extension to an existing cleared device (K173788: Arthrex Corkscrew FT) and a reference device (K082810: Arthrex BioComposite Anchors).
- Performance Data (Non-AI/ML specific): The data presented refers to mechanical (pull-out) and biocompatibility testing, along with bacterial endotoxin testing. This is standard for a mechanical implant and not related to AI/ML performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The information provided pertains to a traditional medical device submission, not an AI/ML diagnostic or assistive technology.
If you have a document describing an AI/ML device study, please provide that, and I will do my best to answer your questions.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.