(263 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, 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 Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint
The Responsive Arthroscopy (RA) 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 polvether ether ketone (PEEK) per ASTM F2026 and Ti-6AI-4V ELI titanium alloy per ASTM F136, along with drivers, taps, and guide wires for screw insertion.
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 20-35mm. 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, and the RA Interference Screw System instruments are non-sterile and are to be sterilized by the end user. The RA PEEK Screws are sterilized with ethylene oxide (EO). The RA Titanium Interference Screws are sterilized with gamma radiation.
The provided text describes the 510(k) premarket notification for the "Responsive Arthroscopy Interference Screw System." This document is a regulatory submission to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. It focuses on the device's design, materials, indications for use, and performance testing to support this claim.
However, the text does not contain the specific information requested about acceptance criteria and study details related to an AI/ML device. The document is about a mechanical surgical screw system, not an AI/ML-driven diagnostic or treatment device. Therefore, I cannot provide the requested details using the provided input.
The sections for acceptance criteria, study design, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are not applicable to the submitted 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.