(16 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 of 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 composed 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 suture may also be provided with the device.
This document is a 510(k) premarket notification for a medical device, the Arthrex SwiveLock Anchors. It focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a new, comprehensive clinical trial for a novel AI device. Therefore, the questions related to AI-specific study design (such as human reader improvement with AI assistance, ground truth for training sets, etc.) are not directly applicable to this document's content.
However, I can extract the information relevant to the device's performance testing and how it meets acceptance criteria for substantial equivalence to its predicate.
Here's the relevant information based on the provided text, framed as closely as possible to your request for acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission for a modification, the "acceptance criteria" are typically defined by demonstrating that the modified device performs equivalently to the predicate device in relevant performance tests, or that the modifications do not introduce new safety or effectiveness concerns. The "reported device performance" is then the outcome of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: The modified device must perform equivalently to the predicate device in terms of: | |
| * Pull-out strength | Testing was performed to demonstrate that the SwiveLock Anchors with the proposed modified eyelet are substantially equivalent to the predicate. |
| * Compressive load resistance | Testing was performed to demonstrate that the SwiveLock Anchors with the proposed modified eyelet are substantially equivalent to the predicate. |
| * Mode of failure | Testing was performed to demonstrate that the SwiveLock Anchors with the proposed modified eyelet are substantially equivalent to the predicate. |
| Biocompatibility/Safety: The device meets pyrogen limits. | Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications. |
| Overall Substantial Equivalence: Differences between the proposed device and predicate are minor and do not raise questions concerning safety or effectiveness. | The Arthrex SwiveLock Anchors are substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences... are considered minor and do not raise questions concerning safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of units or samples used for the pull-out, compressive load, and mode of failure testing, nor for the bacterial endotoxin testing. This level of detail is typically found in the full test reports, which are not part of this summary.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) for a manufacturing modification, the testing would generally be prospective laboratory testing conducted by the manufacturer (Arthrex Inc., located in Naples, Florida, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving human interpretation of medical images or data requiring expert consensus for ground truth. The "ground truth" for mechanical testing is established by the physical testing equipment and methods themselves (e.g., measuring force, observing failure points).
4. Adjudication method for the test set
Not applicable. This is not a study involving human-based data interpretation or classification where adjudication would be necessary.
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 or a study involving human readers.
6. If a standalone (i.e. 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
For the mechanical tests (pull-out, compressive load, mode of failure), the ground truth is established through physical measurement and observation during standardized laboratory testing. For the bacterial endotoxin test, the ground truth is established by laboratory assay results against a pyrogen limit specification.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set. The device is a modification of an existing mechanical anchor.
9. How the ground truth for the training set was established
Not applicable. As above, there is no AI training set.
§ 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.