Search Results

The Arthrex SwiveLock Suture 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, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

. Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunct 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 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 is a 510(k) Summary for the Arthrex SwiveLock Suture Anchor, a medical device for orthopedic fixation. It describes the device, its intended use, and its equivalence to a predicate device. This document is a regulatory submission to the FDA, not a study report on the performance of an AI/ML powered device, therefore, it does not contain the requested information about acceptance criteria and a study proving an AI device meets them.

The sections you've asked for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are typically found in documents related to the validation and performance evaluation of AI/ML software as a medical device (SaMD). This 510(k) is for a physical medical device (suture anchor) and focuses on demonstrating substantial equivalence through mechanical testing and biocompatibility.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The Arthrex SwiveLock Suture 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, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

. Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunct 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 premounted 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 a medical device called the "Arthrex SwiveLock Suture Anchor." This document largely focuses on the regulatory approval process and states that the device is substantially equivalent to existing predicate devices.

However, the text does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: The document states that "Cyclic pull-out testing after 16 weeks of degradation was conducted on the Arthrex SwiveLock Suture Anchor. Results demonstrate that the Arthrex SwiveLock Anchor performs statistically equivalent to the predicate device (K061863 – Arthrex Corkcrew)." It also mentions "Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." However, it does not provide specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons) or the numerical reported performance data. Therefore, a table cannot be created.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set Information: The document is completely silent on these aspects. These details are typically found in a more comprehensive study report or clinical trial summary, not usually in a 510(k) summary focused on substantial equivalence. The tests mentioned (cyclic pull-out, bacterial endotoxin) are mechanical and biological safety tests, not performance studies that would involve human readers, ground truth establishment, or large patient datasets.

In summary, based on the provided text, I cannot complete the requested information. The document confirms that testing was done to show equivalence and meet safety specifications, but it does not disclose the specifics of those tests, such as acceptance criteria values or detailed performance results, nor does it describe studies involving clinical performance evaluation as you've outlined.

Ask a specific question about this device