(30 days)
The Responsive Arthroscopy Wedge Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, 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 Valqus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliguus Advancement. Patellar Tendon Repair. Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair.
The Responsive Arthroscopy (RA) Wedge Push-In Suture Anchor is a knotless suture anchor for the fixation of soft tissue to bone. The system includes suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, passing sutures, inserters, drills, and guide tubes. The suture anchor inserters and instrumentation are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies.
This document is a 510(k) summary for a medical device (Responsive Arthroscopy Wedge Push-In Suture Anchors) and does not describe artificial intelligence/machine learning (AI/ML) software. Therefore, the requested information about acceptance criteria and study details related to an AI/ML device is not present in the provided text.
Specifically, the document focuses on demonstrating substantial equivalence of a physical medical device (suture anchors) to a predicate device through material, design, function, performance, and intended use comparisons, along with bench testing. It does not mention any AI/ML components or studies.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device based on this input.
§ 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.