Search Results

The Acufex® Washer Systems are indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

The Acufex® Washer Systems are used in fixation of soft tissue to bone. The systems include various style polyacetal (with a titanium ring) or titanium washers and titanium screws. The screws are available with a diameter range from 4.5 to 9 mm and 18 to 70 mm in length. Various washers have spikes to engage to bone. Suture spiked washers are designed with spikes for engagement to bone and suture holes to secure suture tendon construct. Also, suture washers are used to secure suture tendon construct to bone.

The provided text is a 510(k) summary for a medical device called the Acufex® Washer System. It describes the device, its indications for use, and compares it to legally marketed predicate devices to demonstrate substantial equivalence.

However, this document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details. This type of information is typically found in the test reports and clinical data sections of a full 510(k) submission, which are not typically included in the publicly available summary.

Therefore, I cannot fulfill your request to create the table and answer the questions based on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

To answer your questions, I would need a different type of document, such as a detailed clinical study report or a design verification and validation report for the device.

Ask a specific question about this device