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The Arthrex Fiber Tak Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

The Arthrex FiberTak Anchors are "all-suture" soft-tissue fixation devices with an expandable push-in design. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and tied in a knot to complete the repair.

The FiberTak anchor is constructed from a hollow braid of polyester with a suture component assembled through the hollow braid. The suture component can be comprised of UHWMPE or a polyblend of UHMWPE and Polyester. The anchor comes preloaded on a disposable inserter made from surgical grade nitinol and ABS plastic. The Arthrex FiberTak Anchors may be sold separately or in a kit with implantation instrumentation. The Arthrex FiberTak Anchors are provided sterile for single use.

The provided text is a 510(k) summary for the Arthrex FiberTak Anchors. This documentation focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria in the way one might for an AI/ML or diagnostic device.

Therefore, the information required to populate most of the sections regarding acceptance criteria, study design, expert ground truth, and training data for an AI/ML device is not present in this document. The document primarily describes physical and functional characteristics and provides performance data in comparison to a predicate device.

Here's an analysis based on the provided text, highlighting what is (and isn't) available:

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria	Reported Device Performance
   Pull-out strength meets or exceeds predicate device.	The submitted mechanical testing demonstrates that the pull-out strength of the proposed Arthrex FiberTak Anchors meet or exceed the pull out strength of the predicate device.
   Pull-out displacements meet predicate criteria.	The pull out displacements recorded were found to meet the criteria established by the predicate devices and therefore of no clinical relevance.
   Biocompatibility of new suture component is acceptable.	Biocompatibility for the new suture component was reviewed and determined to be acceptable due to its similarities in material.
   Packaging/shelf life of new suture component is acceptable.	Packaging/shelf life for the new suture component was reviewed and determined to be acceptable due to its similarities in packaging.

   Note: The document states "meet or exceed" and "determined to be acceptable," but does not provide the specific numerical values for the predicate device's pull-out strength or acceptable displacement range that were used as benchmarks.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   Not specified. The document mentions "submitted mechanical testing" but does not detail the sample size or provenance of the test data (e.g., how many anchors were tested, where the tests were performed).

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)
   Not applicable/Not specified. This device is a physical fixation device, not a diagnostic or AI/ML device that requires expert-established ground truth for its performance evaluation in the traditional sense. Its performance is evaluated through mechanical bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable/Not specified. Adjudication methods are typically relevant for human interpretation or AI output in diagnostic studies, 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 a medical device for tissue fixation, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This is a physical medical device; there is no algorithm or 'standalone' performance in that context. The "standalone" performance would be its mechanical properties, which were tested.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   For mechanical testing, the "ground truth" is established by objective, measurable mechanical properties (e.g., loads, displacements) determined through standardized laboratory testing procedures. It's not a ground truth derived from expert consensus, pathology, or outcomes data in the usual sense for diagnostic products. The comparison is against the predicate device's established performance properties.

8. The sample size for the training set
   Not applicable/Not specified. This is a physical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established
   Not applicable. Refer to point 8.

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