(267 days)
The Responsive Arthroscopy Large Screw-In Suture Anchors are intended to fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
The Responsive Arthroscopy Large Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
The Responsive Arthroscopy Small 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, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament 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.
The Responsive Arthroscopy Knotless 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, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair,
The Responsive Arthroscopy (RA) Suture Anchor System is a family of suture anchors for the fixation of soft tissue to bone. The system includes a variety of suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, inserters, taps, punches, drills, and quide tubes.
The suture anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Suture Anchors range in diameter from 2.5mm to 5.5mm and are either pre-loaded with or accept #2 suture.
The RA Suture Anchor System implants are pre-loaded on inserters and provided sterile, RA Suture Anchor System single-use instruments are provided sterile, and the RA Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user. All RA Suture Anchor System implants and single-use instruments are sterilized with ethylene oxide (EO).
The provided text describes a 510(k) premarket notification for the Responsive Arthroscopy Suture Anchor System. This document outlines the device's indications for use, technological characteristics, and performance testing to demonstrate substantial equivalence to legally marketed predicate devices.
However, the provided text DOES NOT contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance (for an AI model).
- Sample sizes, data provenance, expert numbers, adjudication methods, MRMC studies, or standalone algorithm performance, as these are related to the evaluation of AI/ML models.
- Details on ground truth establishment for AI training or test sets.
The document focuses on the substantial equivalence of a physical medical device (suture anchors) based on its mechanical performance and material properties. The performance testing mentioned ("Suture Characterization," "Insertion Torque Testing," "Static & Fatigue Pullout Force Testing," "Suture Locking Force Testing," "Bacterial endotoxin testing") are engineering and biocompatibility tests typical for a physical orthopedic implant, not studies for an AI/ML algorithm.
Therefore, I cannot fulfill the request as it is predicated on the assumption that the provided text describes an AI/ML device and its validation. The content of the document is solely for a physical medical 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.