(310 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 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 and Bunionectomy.Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. 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.Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.Hip: Capsular repair, acetabular labral repair.
The Arthrex 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 document is a 510(k) summary for the Arthrex SwiveLock Anchors, specifically an amendment to include a new indication for secondary fixation in ACL/PCL reconstruction or repair. This document does not describe a study involving an AI device or a comparative effectiveness study with human readers.
Instead, it focuses on demonstrating substantial equivalence of a medical device (surgical anchors) to previously cleared predicate devices through specific technical and biomechanical testing, rather than clinical performance based on diagnostic accuracy or AI-assisted interpretation.
Therefore, many of the requested fields related to AI performance, human reader studies, and ground truth establishment for a diagnostic algorithm cannot be answered from this document.
However, I can extract information related to the acceptance criteria and the study that demonstrates the device meets these criteria in the context of this 510(k) submission for the Arthrex SwiveLock Anchors.
Here's a breakdown of the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance:
The document states: "Biomechanical testing (ultimate load) was conducted to demonstrate that the use of the SwiveLock as a secondary fixation in ACL reconstruction is greater than a construct without it."
While specific numerical acceptance criteria (e.g., "ultimate load must be > X Newtons") are not explicitly stated as a table in this summary, the acceptance criterion is implicitly "greater than a construct without it". The reported performance is that the SwiveLock did meet this criterion.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Ultimate load of construct with SwiveLock as secondary fixation in ACL reconstruction must be greater than a construct without SwiveLock. | The biomechanical testing demonstrated that the ultimate load was "greater than a construct without it." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in this 510(k) summary. Biomechanical testing usually involves a defined number of samples, but the exact count is not provided.
- Data Provenance: The study is described as "biomechanical testing," implying laboratory-based testing rather than clinical data from a specific country. It's a study conducted specifically to support this regulatory submission, not a retrospective or prospective clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This question is not applicable. For a biomechanical test of a surgical anchor, there isn't "ground truth" derived from expert consensus on diagnostic images. The "truth" is established by the physical testing methods themselves, performed according to established engineering and mechanical testing standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this refers to adjudication of expert opinions for ground truth establishment in studies involving human interpretation or subjective assessment, which is not the case here.
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:
Not applicable. This is not an AI device, and no MRMC study was conducted.
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.):
The "ground truth" for this type of device and study is the direct measurement of physical properties (ultimate load) under controlled laboratory conditions, following validated biomechanical testing protocols. It's not based on expert consensus, pathology, or outcomes data in the traditional medical sense, but rather on direct empirical evidence from engineering tests.
8. The sample size for the training set:
Not applicable. This is not an AI device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI 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.