(41 days)
The Arthrex SwiveLock Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, 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, Midfoot 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, Quadriceps Tendon Repair and Meniscal root repair (4.75 SwiveLock C only). Secondary fixation for ACL/PCL reconstruction or repair (4.75 - 5.5. SwiveLock only).
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Unar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, acetabular labral repair
The Arthrex SwiveLock Anchor is a BioComposite 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. Arthrex cleared suture may also be provided with the device.
This document is a 510(k) premarket notification for the Arthrex SwiveLock Anchors, specifically for the addition of a meniscal root repair indication. It's a regulatory submission, not a study report per se, and it pertains to a physical medical device (suture anchors), not a software or AI-driven device.
Therefore, many of the requested fields are not applicable to this type of document or device. For example, there's no "device performance" in terms of accuracy metrics, no "test set" in the computational sense, no "ground truth" derived from expert consensus on images, no "training set," and no "AI assistance."
However, I can extract information related to the performance data provided to support the new indication.
Here's the breakdown of what can be extracted from the provided text, and where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meniscal root repair (new indication) | Demonstrated that the ultimate load and displacement of the Arthrex SwiveLock are within the acceptable range for meniscal root repair. |
| Pyrogen Limit Specifications | Device meets pyrogen limit specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated numerically (e.g., how many anchors were tested, how many repetitions). The document refers to "testing" performed.
- Data Provenance: The testing was conducted to demonstrate the mechanical properties and biocompatibility of the device for the new indication. It would be considered prospective testing for the purpose of this submission, performed by the manufacturer (Arthrex Inc.). Country of origin is not specified, but the manufacturer is based in Naples, Florida, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable: This relates to a physical device, not an image-based diagnostic or AI system. The "ground truth" here is objective physical and chemical testing results, not expert interpretation.
4. Adjudication Method for the Test Set
- Not Applicable: As above, this is for physical/chemical testing, not expert adjudication of diagnostic outputs. The assessment of whether the ultimate load and displacement are "within the acceptable range" would be based on predefined engineering specifications, not human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: This is not relevant for a physical medical device like a suture anchor. MRMC studies are typically for diagnostic imaging systems or AI products.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable: This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Engineering/Mechanical Specifications and Biocompatibility Standards: The "ground truth" for the performance data involves established mechanical thresholds for ultimate load and displacement in meniscal root repair applications, as well as pyrogen limit specifications defined by standards like EP 2.6.14/USP . It's based on objective physical and chemical measurements rather than expert consensus on interpretation.
8. The Sample Size for the Training Set
- Not Applicable: This is a physical device, and the concept of a "training set" for an algorithm does not apply.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As above, no training set for an algorithm exists here.
§ 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.