Search Results

The FiberTak DX 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

The FiberTak DX is an "all-suture" soft-tissue fixation device. 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.

The provided text describes a 510(k) premarket notification for a medical device called "FiberTak DX." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific performance acceptance criteria for an AI/algorithm-based diagnostic device.

Therefore, the requested information regarding acceptance criteria, study design for AI evaluation (sample sizes, expert involvement, ground truth, MRMC study, etc.), and training data for an algorithm cannot be extracted from the provided text.

The "Performance Data" section briefly mentions:

• Pull-out testing: "demonstrated that the pull out displacements of the proposed FiberTak DX met the criteria established by the predicate device."
• Bacterial endotoxin testing: "conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that a mechanical performance study (pull-out strength/displacement) and a biocompatibility/sterility-related test (bacterial endotoxin) were performed. However, the specific numerical acceptance criteria for these tests and the detailed results are not provided. The document states they "met the criteria established by the predicate device" and "meets pyrogen limit specifications," but does not give the values.

To directly answer your request based on the provided text, I can only indicate what information is not present:

1. Table of acceptance criteria and reported device performance for an AI/algorithm: Not applicable as this is a physical medical device (suture anchor), not an AI/algorithm-based diagnostic device. The document mentions pull-out testing and bacterial endotoxin testing, but no specific numerical acceptance criteria or detailed performance values are given.
2. Sample size for the test set and data provenance: Not applicable for an AI/algorithm. For the physical device tests (pull-out, endotoxin), sample sizes are not specified.
3. Number of experts used to establish ground truth and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable for an AI/algorithm. For the physical device, the "ground truth" would be established by validated mechanical testing methods (for pull-out) and chemical/biological testing methods (for endotoxin), not clinical experts.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance for a physical medical device (suture anchor), not an AI/algorithm diagnostic device. Therefore, the detailed acceptance criteria and study information typically associated with AI/algorithm validation, as requested in your prompt, are not present in this document.

Ask a specific question about this device