The Osteonics® Screw Hole Plugs are intended to occlude the unused dome screw holes of any Osteonics acetabular shell component. The Osteonics® Screw Hole Plugs will be used either with or without bone cement depending upon the labeled indications of the associated acetabular shell component. The Osteonics® Screw Hole Plugs do not carry their own indications and contraindications, but-as accessories to acetabular shell components -- would be subject to all of the indications and contraindications of the associated acetabular shells.

Device Description

The Osteonics® Screw Hole Plugs are small circular plugs which are manufactured from low density polyethylene and which are intended to occlude all acetabular dome screw holes not occupied by bone screws. The Osteonics® Screw Hole Plugs will be factory-assembled to every acetabular dome screw hole in the acetabular shell. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. The Osteonics® Screw Hole Plugs, by occluding the shell screw holes, will help prevent intrusion of bone cement into the shell and potential migration of debris through open screw holes into the acetabulum.

AI/ML Overview

This document describes a 510(k) premarket notification for the Osteonics® Screw Hole Plugs. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding an acceptance criteria study is not applicable or cannot be extracted from the provided text.

Here is an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a structured format with corresponding performance metrics. The "Performance Data" section briefly mentions: "Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading." However, it does not detail:

What "as intended" means in measurable terms (e.g., maximum allowable cement intrusion, debris migration rate, mechanical integrity under specific loads).
The specific results of this laboratory testing against any pre-defined thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document refers to "laboratory testing" and not a clinical study involving a test set of human subjects. Thus, there is no sample size for a test set or data provenance in terms of human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts is described as this is not a study requiring human interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI medical device or an imaging device requiring human reader interpretation. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (screw hole plugs), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this device, the "ground truth" would likely be engineering specifications or functional performance metrics demonstrated through bench testing (e.g., seal integrity, resistance to displacement). The document mentions "simulated physiological loading," implying a mechanical or functional evaluation rather than clinical ground truth like pathology or outcomes.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary

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FEB 28 1997

K965056

510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Screw Hole Plugs

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677
Contact Person:	Terry SheridanRegulatory Affairs Specialist
Date of Summary Preparation:	December 17, 1996
Device Identification

Proprietary Name:

Common Name:

.. ... .. .

Classification Name and Reference:

Osteonics® Screw Hole Plugs

Prosthesis, hip, cement restrictor

Surgical mesh 21 CFR §878.3300

Predicate Device Identification

The Osteonics" 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® UHMWPE Acetabular Shell Cement Spacer System, .
Osteonics® Acetabular Screw Hole Plugs, .
. Osteonics® Universal Cement Plug

Device Description

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acetabular dome screw hole in the acetabular shell. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw.

The Osteonics® Screw Hole Plugs, by occluding the shell screw holes, will help prevent intrusion of bone cement into the shell and potential migration of debris through open screw holes into the acetabulum.

Intended Use:

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® Screw Hole Plugs and the predicate Osteonics® Acetabular Screw Hole Plugs are both circular disks intended to occlude unused screw holes. The subject devices are preassembled to their shells at Osteonics, and may be removed by the surgeon intraoperatively. The predicate devices were not pre-assembled, but instead were assembled to their shells intraoperatively .

Materials

The subject devices are made from low density polyethylene. The predicate cement plug is made from the same low density polyethylene as the subject device. The subject devices have been designed so that they contact neither the acetabular insert nor the acetabular host bone. Because the subject devices are non-load bearing, low density polyethylene is an appropriate material for this application.

Intended Use:

Both the subject Osteonics® Screw Hole Plugs and the predicate Osteonics® Acetabular Screw Hole Plugs are intended to occlude unused screw holes, thus prevential intrusion of bone cement and potential emigration of debris through the shell screw holes into the acetabulum. Both the subject and predicate devices are intended for cementless applications, depending upon the intended use of the associated acetabular shell.

Performance Data:

Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading.

Regulation Number and Section

§ 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.