(56 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, 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis and MPFL Repair/Reconstruction
- · Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
· Elbow: Biceps Tendon Reattachment, Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)
· 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.
The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock Anchor. It aims to expand the indications for use of the 3.9mm BioComposite SwiveLock suture anchor to include MPFL Repair/Reconstruction. The submission focuses on demonstrating substantial equivalence to a predicate device (K192532).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: Pull-out (tensile) strength of the proposed Arthrex SwiveLock Anchor for MPFL repair/reconstruction should meet criteria established by published literature. | Met the criteria established by published literature for MPFL repair/reconstruction. |
| Bacterial Endotoxin Testing: Device must meet pyrogen limit specifications as per USP , USP , FDA Guidance for Industry Pyrogen & Endotoxin Testing, and EP 2.6.14. | Met pyrogen limit specifications. |
| Substantial Equivalence: The device should have the same technological characteristics (device design, sterilization, biocompatibility) and substantially equivalent intended uses as the predicate device (K192532). Differences should be minor and not raise questions concerning safety or effectiveness. (This is a regulatory rather than a performance criterion, but it's central to the submission.) | The proposed and predicate devices have the same technological characteristics. Differences are minor and do not raise questions concerning safety or effectiveness. |
No clinical studies involving human readers or AI performance are mentioned in this document. This 510(k) pertains to a physical medical device and its mechanical/biocompatibility performance, not a software device that interprets images or data. Therefore, many of the requested sections below are not applicable.
2. Sample size used for the test set and the data provenance
- Mechanical Testing: The document does not specify the sample size for the mechanical testing (pull-out strength).
- Bacterial Endotoxin Testing: The document does not specify the sample size for the bacterial endotoxin testing.
- Data Provenance: Not applicable as this is laboratory testing of a device, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical and endotoxin testing is established by standard laboratory methods and specifications, not by expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for expert consensus on clinical data, not for laboratory testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or is referenced in this document. This filing is for a physical medical device (suture anchor), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Testing: Ground truth is defined by established "published literature" regarding the required pull-out strength for MPFL repair/reconstruction.
- Bacterial Endotoxin Testing: Ground truth is defined by established regulatory and quality standards (USP , USP , FDA Guidance, EP 2.6.14) for pyrogen limits.
8. The sample size for the training set
Not applicable. This is a physical device and does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This is a physical device and does not involve a "training set" or "ground truth" establishment in the context of machine learning.
§ 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.