(98 days)
The Stryker Self-Punching ICONIX Anchors are intended to be used for soft-tissue to bone fixation in the elbow, shoulder, knee and hip. See indications below.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
The Self-Punching ICONIX Anchors (herein referred to as the proposed device(s)) are all suture anchors with a push-in design, provided sterile and preloaded on a disposable inserter. The anchors consist of a polyester sheath interwoven over non-absorbable working sutures, which are folded over and mounted on the forked tip of the inserter. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone. The anchor preloaded on the inserter is packaged in a single-use sterile barrier system (SBS).
The provided text is a 510(k) summary for the Stryker Self-Punching ICONIX, a medical device for soft-tissue to bone fixation. It does not describe a study involving acceptance criteria and a device's performance against them in the context of an AI/algorithm-based diagnostic or prognostic device.
Instead, this document describes and demonstrates the substantial equivalence of a new medical device (Stryker Self-Punching ICONIX Anchors) to existing predicate devices based on non-clinical benchtop testing. The performance data presented focuses on fixation strength and insertion effort, not on diagnostic accuracy, sensitivity, specificity, or reader performance in an AI context.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not addressed in this document for the described device.
§ 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.