(35 days)
The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ ankle, knee, hand/wrist, elbow, and hip 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 Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
. Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only).
- . 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.
. Hip: Capsular repair, acetabular labral repair.
The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is premounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.
The provided text describes a 510(k) premarket notification for a medical device called the "Arthrex SwiveLock Suture Anchor." This document largely focuses on the regulatory approval process and states that the device is substantially equivalent to existing predicate devices.
However, the text does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: The document states that "Cyclic pull-out testing after 16 weeks of degradation was conducted on the Arthrex SwiveLock Suture Anchor. Results demonstrate that the Arthrex SwiveLock Anchor performs statistically equivalent to the predicate device (K061863 – Arthrex Corkcrew)." It also mentions "Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." However, it does not provide specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons) or the numerical reported performance data. Therefore, a table cannot be created.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set Information: The document is completely silent on these aspects. These details are typically found in a more comprehensive study report or clinical trial summary, not usually in a 510(k) summary focused on substantial equivalence. The tests mentioned (cyclic pull-out, bacterial endotoxin) are mechanical and biological safety tests, not performance studies that would involve human readers, ground truth establishment, or large patient datasets.
In summary, based on the provided text, I cannot complete the requested information. The document confirms that testing was done to show equivalence and meet safety specifications, but it does not disclose the specifics of those tests, such as acceptance criteria values or detailed performance results, nor does it describe studies involving clinical performance evaluation as you've outlined.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.