(191 days)
The Arthrex SwiveLock 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 Repairs, 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, 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 SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. FiberWire suture may also be provided with the device.
The provided 510(k) summary (K101823) describes the Arthrex SwiveLock Anchors, a medical device intended for fixing suture (soft tissue) to bone in various anatomical regions. The device is seeking substantial equivalence to previously marketed predicate devices.
1. Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the Arthrex SwiveLock Anchors are based on demonstrating substantial equivalence to existing predicate devices. Since this is an equivalence submission, specific quantitative acceptance criteria for absolute performance metrics are not explicitly stated in the summary. Instead, the performance is compared against the known performance of the predicate devices.
The study aimed to demonstrate that the SwiveLock Anchors perform comparably to the predicate devices in terms of:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Degradation (for Bio/BioComposite materials) | 26-week degradation data demonstrated substantial equivalence. |
| Mechanical Pull-Out (Tensile) Strength | Mechanical pull-out (tensile) testing data demonstrated substantial equivalence to the pull-out forces of the predicate devices. |
| Insertion Characteristics | Insertion testing data demonstrated substantial equivalence. |
| In-vivo Performance (Histology, Pull-Out, Imaging) | Animal testing (including histology, in-vivo pull-out, and in-vivo imaging) data demonstrated no new issues of safety and effectiveness, implying comparable in-vivo performance. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each test mentioned (degradation, mechanical pull-out, insertion, animal testing). It only refers to "data" for each category.
The data provenance is not specified. It is an industry standard to conduct these tests in a controlled laboratory environment or animal models. Neither the country of origin nor whether the data is retrospective or prospective is mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to this type of 510(k) submission. Establishing "ground truth" by experts is typically relevant for diagnostic or AI-driven devices where human interpretation is involved. For a mechanical device like a suture anchor, the "truth" is established through physical and biological testing against established standards or predicate device performance.
4. Adjudication Method:
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts in diagnostic studies, which is not relevant for the mechanical and biological testing of a suture anchor.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is evaluated.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
The "ground truth" in this context is established through physical and biological testing methodologies. This includes:
- Degradation data: Measuring the breakdown of biomaterials over time.
- Mechanical pull-out (tensile) testing data: Quantifying the force required to pull the anchor out of bone, adhering to engineering standards.
- Insertion testing data: Assessing the ease and characteristics of device insertion.
- Animal testing data: Observing the biological response (histology), in-vivo pull-out strength, and imaging of the device in a living system.
The "truth" is rooted in the physical and biological properties and performance of the device as measured by these tests, compared against the known performance of predicate devices.
8. Sample Size for the Training Set:
This information is not applicable. "Training set" refers to data used to train machine learning algorithms. The Arthrex SwiveLock Anchor is a mechanical device, not an AI or algorithm-driven system.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above.
§ 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.