(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.
{0}------------------------------------------------
MAY - 9 1997
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics" Tibial Tray Screw Hole Plugs
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
Date of Summary Preparation:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Kate Sutton Regulatory Affairs Specialist
March 3, 1997
Osteonics Tibial Tray Screw Hole Plugs
Tibial tray screw hole plugs
Surgical mesh 21 CFR §878.3300
Predicate Device Identification
The Osteonics" Tibial Tray Screw Hole Plugs are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:
- Osteonics® Omnifit® Total Knee System Screw Hole Plugs .
- Osteonics® Universal Cement Plug .
Device Description
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
{1}------------------------------------------------
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.
Intended Use:
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.
Statement of Technological Comparison:
The substantial equivalence of the subject devices to the predicate devices, in terms of design, materials, and intended use are discussed below.
Design:
The subject Osteonics® Tibial Tray Screw Hole Plugs and the UHMWPE screw hole plugs discussed in the predicate 510(k) are both circular disks intended to occlude unused screw holes. The subject devices are pre-assembled to their tibial trays at Osteonics, and may be removed by the surgeon intraoperatively.
Materials
The subject devices are made from low density polyethylene (LDPE). This material was chosen for its successful clinically demonstrated history of use, as well as its ability to be injection molded. The predicate cement plug is made from the same low density polyethylene as the subject Because the subject devices are non-load bearing, low density polyethylene is an device. appropriate material for this application.
Intended Use:
Both the subject Osteonics® Tibial Tray Screw Hole Plugs and the UHMWPE tibial tray screw hole plugs of the predicate Omnifit® Total Knee System are intended to occlude unused screw holes, thus preventing potential intrusion of bone cement.
The subject and predicate devices are intended for cemented applications only.
Performance Data:
Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading.
§ 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.