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FiberTak DR is 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

FiberTak DR is an "all-suture" soft-tissue fixation device 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 or though soft tissue and tied in a knot; or the repair can be completed in a knotless fashion when used in combination with Arthrex SwiveLock Anchors (K101823). FiberTak DR is constructed from a hollow braid of polyester with a suture component combination assembled through the hollow braid. The suture component can be made from either UHWMPE or a polyblend of UHMWPE and Polyester. The anchor configuration of FiberTak DR is similar to the predicate device, except that it combines suture and tape within the same anchor. FiberTak DR is available in three models with combinations in the color of its suture components. FiberTak DR comes preloaded on a disposable inserter made from stainless steel (ASTM F899) whereas the predicate inserter is made of nitinol. The handle of the inserters is made of ABS plastic. FiberTak DR may be sold separately or in a kit with implantation instrumentation. The proposed FiberTak DR is provided sterile for single use.

The provided document is a 510(k) premarket notification for the FiberTak DR device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through clinical studies or extensive performance testing with pre-defined thresholds.

Therefore, the document does not contain the following information typically associated with acceptance criteria and a study proving a device meets them:

• A table of acceptance criteria and the reported device performance: While mechanical testing is mentioned, specific acceptance criteria and detailed performance results are not provided in this summary.
• Sample sized used for the test set and the data provenance: Not explicitly stated for performance testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a device performance submission, not a diagnostic accuracy study.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as this is a device performance submission, not a diagnostic accuracy study or an AI-assisted interpretation study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable in the context of this device's performance testing.
• The sample size for the training set: Not applicable (no AI/algorithm training set).
• How the ground truth for the training set was established: Not applicable.

What is stated in the document regarding how the device meets regulatory requirements:

The submission focuses on demonstrating substantial equivalence to a predicate device (K151230: Arthrex FiberTak Anchors) based on:

1. Similar basic design features (all-suture anchor).
2. Similar materials.
3. Similar intended use.
4. Mechanical testing: "The submitted mechanical testing demonstrates that the pull-out strength of the proposed FiberTak DR exceeds the pull out strength of the predicate device. In addition, the pull out displacements recorded meet the criteria established by the predicate devices and therefore of no clinical relevance."
5. Biocompatibility and packaging/shelf life: Determined acceptable due to similarities in material and packaging with the predicate device.

In summary, the FDA's clearance is based on the finding that the FiberTak DR is substantially equivalent to existing devices, primarily supported by comparative mechanical testing showing its performance is at least equivalent to, if not exceeding, that of the predicate device. The document does not detail specific acceptance numeric thresholds, but rather implies that performance equivalent to a previously cleared device is the "acceptance criterion" for this type of submission.

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