Search Results

The X-Twist Biocomposite Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:

Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromo-Clavicular Separation Repair, Deltoid Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Meniscal Root Repair, Secondary or adjunct fixation for ACL/PCL reconstruction or repair, MPFL Repair/Reconstruction

Elbow: Ulnar/Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair

The X-Twist Biocomposite Suture Anchor consists of the implants (anchor and anchor tip) and the anchor driver assembly. The anchor and anchor tip are provided assembled to the driver and sterile. The X-Twist Biocomposite anchor is molded using a composite of beta-TCP (beta-tricalcium-phosphate) and PLGA (poly-lactic-co-glycolic acid). The anchor tip is molded using PEEK (polyetheretherketone). The anchor is fully threaded, double-helical, cannulated, and has inline fenestrations on each quarter-turn face. The anchor tip is retained on the driver via retention suture(s) or suture tape(s) that are passed through the driver cannulation, looped over the retention bridge within the tip, and returned out the proximal end of the driver handle and cleated. These devices are to be used with a drill, awl, and/or bone tap. The X-Twist Biocomposite Suture Anchors are provided sterile and in 4.75mm, 5.5mm, or 6.25mm diameters.

The X-Twist Biocomposite Suture Anchor, as described in this 510(k) summary, did not undergo a study to prove acceptance criteria in the traditional sense of a clinical or standalone performance study. Instead, the FDA determined substantial equivalence based on non-clinical testing and comparison to predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For the specific non-clinical test reported, here are the acceptance criteria and results:

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

• Sample Size for Endotoxin Test: Ten (10) disassembled devices were used.
• Data Provenance: Not specified, but generally, non-clinical tests performed for FDA submissions are conducted by the manufacturer or a contracted lab. This is a non-clinical, in-vitro test.

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

Not applicable. For this type of non-clinical endotoxin test, ground truth is established by scientific standards and analytical methods, not human experts.

4. Adjudication Method for the Test Set

Not applicable. This was a laboratory test with quantitative results measured against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical medical implant (suture anchor), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

For the reported LAL endotoxin test, the ground truth is established by the analytical measurement against a defined standard, specifically the USP (United States Pharmacopeia) guidelines for Limulus Amebocyte Lysate (LAL) testing, with a Control Standard Endotoxin (CSE) curve.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI model, there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device