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The Arthrex FiberTak Suture Anchor is 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, biceps tenodesis, acromio-clavicular separation repair, deltoid repair, capsular shift or capsulolabral reconstruction

· Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers

· Knee: Medial collateral ligament repair, lateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, and joint capsule closure, medial patellofemoral ligament repair/reconstruction, and anterolateral ligament repair/reconstruction

• Hand/Wrist: Scapholunate ligament reconstructions, repair/reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

· Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondy.itis repair

· Hip: Acetabular labral repair and gluteal tendon repair

The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. The anchor is constructed from a hollow braid of polyester with a single loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is pre-loaded on a disposable inserter and will be sold sterile for single-use.

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone. The submission is to expand indications of the 2.6 mm FiberTak Suture Anchor to include Anterolateral Ligament Repair/Reconstruction.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for the Test Set and Data Provenance:

The document does not explicitly state the sample size (number of anchors tested) for the mechanical testing. It also doesn't specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "mechanical testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This is not applicable as the study involved mechanical testing against established criteria from published literature, not expert human assessment to establish a "ground truth" for diagnostic or prognostic purposes.

4. Adjudication Method for the Test Set:

Not applicable, as this was mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not relevant for a mechanical device like a suture anchor. The assessment focuses on the physical properties of the device, not its performance in interpretation by human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Not applicable. This device is a physical medical implant, not an AI algorithm. Its performance is inherent in its mechanical properties.

7. Type of Ground Truth Used:

The ground truth for the acceptance criteria was "criteria established by published literature for anterolateral ligament repair/reconstruction." This implies a consensus or widely accepted standard derived from previous research on the biomechanical requirements for such repairs.

8. Sample Size for the Training Set:

Not applicable. As this is a mechanical medical device, there is no "training set" in the context of machine learning or AI models.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this type of medical device.

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