(19 days)
The Responsive Arthroscopy Interference Screws are intended to be used for fixation of tissue including ligament, tendon, soft tissue, or bone to bone. Interference fixation with PEEK or Titanium Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically, screws are intended for use 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, Anterior Shoulder Instability
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle, Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Reconstruction, Lateral Epicondylitis Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint
The Responsive Arthroscopy Interference Screw System is a family of interference screws for the reattachment and fixation of tissue including ligament, tendon, soft tissue, or bone to bone. The system includes cannulated interference screws in both polyether ether ketone (PEEK) per ASTM F2026 and Ti-6Al-4V ELI titanium alloy per ASTM F136, along with drivers, sizers, reamers, taps, and guide wires for screw insertion.
The only design differences in the subject device are regarding interference screw length, cannulation, and driving feature. The screws are available in a variety of sizes to accommodate various procedures and patient anatomies. RA PEEK Interference Screws are offered with diameters from 7-12mm and lengths from 15-35mm. RA Titanium Interference Screws are offered with diameters from 7-10mm and lengths from 20-35mm.
The RA Interference Screw System implants are provided sterile. The RA Interference Screw System single-use instruments are provided sterile, and the RA Interference Screw System reusable instruments are non-sterile and are to be sterilized by the end user. All RA Interference Screw implants and single-use instruments are sterilized with ethylene oxide (EO).
This document pertains to the 510(k) clearance of the Responsive Arthroscopy Interference Screw System and does not contain information about the performance or acceptance criteria of an AI/ML powered medical device or a study proving its performance. The provided text is a 510(k) clearance letter and associated summary documents for a physical medical device (interference screws) and explicitly discusses mechanical and material properties, not an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth for the training set, as these concepts are not applicable to the content of the provided document.
§ 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.