(84 days)
The Smith & Nephew EndoButton Direct Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.
The EndoButton Direct is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. The design of the EndoButton Direct allows for the device to be endoscopically delivered from a single access point. The device is available in 5-10mm lengths to accommodate different graft sizes.
The provided text is a 510(k) summary for the Smith & Nephew EndoButton Direct, a fixation device for tendons and ligaments. It establishes substantial equivalence to a predicate device, but it does not contain any information about specific acceptance criteria or performance data beyond a general statement of equivalency. Therefore, I cannot construct a table of acceptance criteria or describe a study that proves the device meets them from this document.
The document states:
- "The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew EndoButton CL, cleared in K980155. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy."
This indicates that performance testing was done, but the details of that testing, including acceptance criteria, results, sample sizes, ground truth establishment, or expert involvement, are not provided in this 510(k) summary.
Therefore, I cannot answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, experts, adjudication, or MRMC studies based solely on the provided text.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.