(24 days)
The FiberTak® Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
The FiberTak® Suture Anchors are intended for the following indications:
• 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 Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure
• Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.
The FiberTak® Suture Anchors are all-suture anchors intended to be used for soft tissue to bone fixation.
The provided text is a 510(k) Summary for a medical device (FiberTak® Suture Anchor) and does not contain the information requested about acceptance criteria and a study proving device performance as it relates to AI/ML or diagnostic performance.
The document describes performance data as:
- Ultimate load testing and cyclic displacement: Performed to demonstrate that differences in the subject device (a line extension) do not negatively impact mechanical strength compared to the predicate device.
- Bacterial endotoxin per USP : Conducted to demonstrate that the device meets pyrogen limit specifications.
These tests are standard for evaluating the mechanical and biocompatibility aspects of a physical medical device, not the diagnostic or predictive performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on this 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.