Search Results

Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of auto- and allografts.

The MectaScrew Extension includes implantable devices used for the tibial and the femoral fixation of the graft in reconstructive treatment of knee ligament ruptures. They have been developed to provide interference between a ligament graft and a bone tunnel in the ligament reconstruction surgery.

The MectaScrew Extension implants includes MectaScrew C, a composite interference screw made of RESOMER® Composite LR 706S B-TCP, a mixture of 70 % RESOMER® LR 706 S and 30 % B-TCP.

MectaScrew C is available in 19 different configurations ranging from 6 to 12 mm in diameter and 15 to 35 mm in length.

The provided text is a 510(k) summary for a medical device called "MectaScrew Extension." This document outlines the device's characteristics, its intended use, and its comparison to predicate devices to establish substantial equivalence.

Crucially, the document states: "No clinical studies were conducted." This means there is no study evaluating the device's performance against pre-defined acceptance criteria with human subjects or actual clinical outcomes in the format you've requested.

Therefore, I cannot provide information on:

• A table of acceptance criteria and reported device performance (as no clinical performance criteria or results are given).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications used to establish ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or its effect size.
• Standalone performance.
• Type of ground truth used (as no clinical ground truth was established from a study).
• Sample size for the training set (no AI/ML component described).
• How ground truth for the training set was established (no AI/ML component described).

The document focuses on non-clinical studies (design validation, performance testing like torque resistance and pull-out strength, MR safety, pyrogenicity, and biocompatibility) to demonstrate substantial equivalence to predicate devices. These non-clinical tests would have their own internal acceptance criteria, but these are not for the "device performance" in the clinical sense you are asking for.

In summary, based on the provided text, the MectaScrew Extension did not undergo a clinical study to prove its performance against acceptance criteria in human use. Its clearance was based on demonstrating substantial equivalence through non-clinical data and comparison to existing legally marketed devices.

Ask a specific question about this device