(66 days)
The Osteonics® Tibial Tray Screw Hole Plugs are intended to occlude the unused tibial screw holes of any Osteonics tibial tray component. The Osteonics® Tibial Tray Screw Hole Plugs will be used with bone cement. The Osteonics® Tibial Tray Screw Hole Plugs do not carry their own indications and contraindications, but -- as accessories to tibial tray components -- would be subject to all of the indications and contraindications of the associated tibial trays.
The Osteonics® Tibial Tray Screw Hole Plugs are small circular plugs which are manufactured from low density polyethylene (LDPE) and which are intended to occlude all tibial tray screw holes not occupied by bone screws. The Osteonics® Tibial Tray Screw Hole Plugs will be factory-assembled into every tibial tray hole. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. The Osteonics® Tibial Tray Screw Hole Plugs, by occluding the tibial tray screw holes, will help prevent intrusion of bone cement onto the surface of the tibial tray.
This document is a 510(k) Premarket Notification Summary for the Osteonics Tibial Tray Screw Hole Plugs. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
However, the provided text does not contain any information about acceptance criteria, device performance results, or any study design details that would typically be associated with AI/ML device testing.
Specifically, most of the requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is entirely absent because the device in question is a physical medical device (tibial tray screw hole plugs), not an AI/ML-driven software or diagnostic tool.
The "Performance Data" section merely states: "Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading." No results, acceptance criteria, or experimental details are provided.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about study design, as this information is not present in the provided document.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.