(33 days)
The Arthrex SwiveLock Anchor is 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, Mid-foot reconstruction, Metatarsal Ligament Repair, Tendon Repair, Bunionectomy
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- · Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
- · Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondy.itis Repair
· Hip: Capsular Repair, Acetabular labral repair
The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted 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.
This document describes the FDA clearance for the Arthrex SwiveLock Anchor. As such, the information provided focuses on the regulatory review process and the basis for substantial equivalence to predicate devices, rather than a clinical study evaluating the performance of a medical device against specific acceptance criteria.
Therefore, the specific information requested in your prompt regarding acceptance criteria and a study to prove the device meets these criteria (including sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not present in the provided text.
The document primarily states:
- Performance Data: "Mechanical testing demonstrated that the pull-out (tensile) strength of the proposed Arthrex SwiveLock Anchor met the criteria established by the predicate device and that the anchor was successfully inserted into the bone substitute. Geometric analysis and Load vs Degradation Time comparison was conducted to demonstrate that the expected degradation and pull out strength of the proposed anchor is not a new worst case over the predicate and referenced predicate devices. Bacterial endotoxin per USP , USP , FDA Guidance for Industry Pyrogen & Endotoxin Testing and EP 2.6.14 was conducted to demonstrate that the device meets pyrogen limit specifications."
This indicates that mechanical and biocompatibility tests were performed, and the results were compared against established criteria or predicate device performance. However, it does not provide the quantitative acceptance criteria, the specific methodology of these tests (e.g., number of samples tested, blinding, etc.), or details of a study meeting the criteria you've outlined for clinical performance or an AI/human-in-the-loop system.
In summary, the provided text from the FDA 510(k) clearance letter and summary does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria in the context of an AI-driven or diagnostic device. This document pertains to a mechanical surgical implant, and the assessment for such a device is typically based on mechanical properties, biocompatibility, and substantial equivalence to existing devices, rather than the types of performance metrics and study designs common for AI/human reader studies.
§ 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.