Search Results

The Arthrex TensionLocTM System is indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

The Arthrex TensionLocTM System is a two-component system comprised of a polyetheretherketone (PEEK) plug and a mating collar for suture fixation within a bone tunnel.

The primary differences between the Arthrex TensionLocTM System and the predicate device are the geometry and material. The proposed Arthrex TensionLocTM System contains a ribbed outer edge collar and plug as opposed to the predicate geometry of a double spiked plate and cannulated post. The Arthrex TensionLocTM System is also manufactured of PEEK material whereas the predicate is manufactured from titanium. The Arthrex Tension LocTM System will offer external diameters of 11, 14, and 16 as opposed to the 13-22 mm range of the predicate. The Arthrex TensionLocTM System is 9.1 mm in length as opposed to the various lengths of the predicate (24-40 mm).

This document outlines the FDA's 510(k) clearance for the Arthrex TensionLocTM System, a medical device for orthopedic procedures. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of an AI/ML product's performance against acceptance criteria. Therefore, most of the requested information regarding AI/ML study design, acceptance criteria, multi-reader studies, and ground truth establishment is not applicable or cannot be extracted from this document.

However, I can extract information related to the device's performance testing from the "Performance Data" section of the 510(k) Summary.

Here's the relevant information that can be extracted:

• Device Name: Arthrex TensionLocTM System
• Purpose: Fixation of soft tissue (tendons and ligaments) to bone in orthopedic procedures.
• Predicate Device: K994202: Acufex® Washer System

Since this is a mechanical device clearance and not an AI/ML product, the questions related to AI/ML specific study design (e.g., sample size for test/training set, number of experts, MRMC studies, ground truth establishment for AI) are not directly addressed.

The "Performance Data" section details the studies conducted to demonstrate safety and effectiveness for this type of medical device:

1. Acceptance Criteria and Reported Device Performance (Table):

Performance Conclusion: "The submitted mechanical testing data demonstrates that the performance of the proposed devices meets or exceeds the predicate device for the desired indications."

2. Sample size used for the test set and the data provenance: Not explicitly stated for each test, but typically, these tests involve a defined number of device samples manufactured under controlled conditions. The data provenance is internal to the manufacturer (Arthrex Inc., Naples, FL). The study is prospective in the sense that the tests are designed and executed specifically for this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical and biocompatibility testing of a physical medical device, "ground truth" is established through standardized testing protocols, material specifications, and comparison to predicate device performance, not expert human interpretation.

4. Adjudication method for the test set: Not applicable. Testing results are quantitative and objective, not subject to human adjudication in the context of diagnostic interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML diagnostic device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not a software algorithm.

7. The type of ground truth used:
* Mechanical Performance: Comparison to "predicate device performance" (implied "gold standard" of a previously cleared device) and meeting specified mechanical properties.
* Biocompatibility: Adherence to ISO 10993-1 standards, which involve in vitro and in vivo tests for cytotoxicity, sensitization, irritation, etc.
* Sterilization: Adherence to ISO 11135:2014 standards, ensuring a specified sterility assurance level (SAL).
* Pyrogenicity: Meeting bacterial endotoxin limits specified by pharmacopeial standards (EP/USP).

8. The sample size for the training set: Not applicable. This is not an AI/ML product that undergoes a "training" phase with data.

9. How the ground truth for the training set was established: Not applicable. No training set is used for this type of device.

Ask a specific question about this device