Search Results

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;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction:
Hip: Capsular repair, Acetabular Labral Repair.

The HEALIX ADVANCE BR Anchor is absorbable threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone. The suture options may include needles to facilitate suture passage through tissue. HEALIX ADVANCE BR Anchor is provided sterile and is for single patient use only.

The provided document describes a medical device, the HEALIX ADVANCE™ BR Anchor, and its substantial equivalence to previously marketed predicate devices. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic or AI-based device.

This document is a 510(k) summary for a bone anchor, which is a physical medical device (implant) used for fixation of soft tissue to bone. The "Safety and Performance" section states: "Design verification activities, such as Anchor Torque, Anchor Pull Out (at T=0 and in vitro testing throughout the healing period) were performed against pre-defined acceptance criteria according to the intended use. Results of performance testing have demonstrated that the proposed devices are suitable for their intended use."

This indicates that mechanical performance testing was done for the physical implant, but the details of the acceptance criteria, specific study results, sample sizes for these tests, or any form of "ground truth" or expert adjudication are not included in this regulatory summary. These details would typically be found in the full 510(k) submission or design verification reports, which are not provided here.

Therefore, I cannot fulfill the request as it pertains to acceptance criteria and a study proving a diagnostic device's performance, an AI-based device's performance, or a multi-reader multi-case (MRMC) comparative effectiveness study. The request's questions are geared towards the evaluation of diagnostic algorithms or software, which is not the subject of this document.

Ask a specific question about this device