(28 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 skeletally mature pediatric and adult patients for the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, and MPFL Repair/Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular labral repair.
The proposed Arthrex 3.9 mm SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex 3.9 mm SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. The Arthrex 3.9 mm SwiveLock Anchor can be used with Arthrex 510(k) cleared suture.
The provided text is a 510(k) summary for a medical device (Arthrex 3.9 mm SwiveLock Anchor). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven device through a clinical study.
Therefore, the information required to answer your specific questions about acceptance criteria, study design, ground truth establishment, expert adjudication, and MRMC studies for an AI device is not present in this document.
The performance data mentioned in the document relates to:
- Packaging validation and 5-year accelerated aging shelf-life testing: This ensures the packaging maintains product integrity and sterility.
- Bacterial Endotoxins Test (BET): This tests for pyrogens to ensure the device is safe for implantation.
These are engineering/manufacturing performance tests, not clinical performance studies typically associated with AI/algorithmic devices.
Here's why your questions cannot be answered from this text:
- AI/Algorithm-driven device: The Arthrex 3.9 mm SwiveLock Anchor is a mechanical bone fixation appliance, not an AI or algorithm-driven medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance (e.g., sensitivity, specificity, AUC) do not apply to this submission.
- Clinical Study Design: The document describes a "Special 510(k)" submission, which typically focuses on minor modifications to a previously cleared device. It relies heavily on comparisons to predicate devices and engineering bench testing rather than new, large-scale clinical trials with human subjects.
- Ground Truth: The concept of "ground truth" (expert consensus, pathology, outcomes data) is relevant for diagnostic or image-analysis AI. For a mechanical implant, "performance" is assessed through biomechanical testing, material properties, and sterility, not clinical diagnostic accuracy.
In summary, the provided document does not contain the information required to address your specific questions because the medical device it describes is a mechanical implant, not an AI or algorithm-driven device.
§ 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.