(184 days)
The ATL Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
• Shoulder: Rotator Cuff Repair, Acromioclavicular Sepair, Bankart Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
· Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
· Hand/Wrist: Scapholunate Ligament Reconstruction, Unar or Radial Collateral Ligament Reconstruction, TFCC.
· Hip: Acetabular labral repair.
The ATL Anchors are press fit suture anchors designed to secure the implant in bone and provide suture fixation. There are two configurations: with and without an eyelet. The devices are made from PEEK, are provided sterile, and pre-mounted on a single-use driver. The devices are provided with USP 0 ultra-high molecular weight polyethylene (UHMWPE) suture. ATL Anchors are used with Artelon® provided cannulated or solid stainless-steel drill bits. The devices are tapped into a pilot hole using a standard mallet (not provided).
The provided text is a 510(k) summary for the ATL Anchors, a medical device for soft tissue to bone attachment. It details the device description, indications for use, technological characteristics, and summary performance data. However, it does not describe an AI/ML-based device or a study involving human readers or expert consensus for ground truth. Therefore, I cannot generate the requested information about acceptance criteria, performance data, sample sizes, expert involvement, or MRMC studies.
The document discusses performance tests for the biomechanical properties of the ATL Anchors, such as insertion strength, pull-out strength, and cyclic loading, to demonstrate equivalence to predicate devices. It also mentions sterilization, shelf-life, and biocompatibility testing. These are typical engineering and safety tests for a physical medical device, not performance evaluations of an AI algorithm.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.