for prescription use only, as a means of temporary communication of the outer and middle ear to provide ventilation or drainage of the middle ear when inserted through an incision in the tympanic membrane.

Device Description

Each fluoroplastic ACTIVENT tube will be manufactured from a fluoroplastic resin blended with a silver compound and a colorant. This proprietary process results in ventilation tubes that exhibit bacteriocidal/bacterostatic properties. As with the current silicone ACTIVENT tubes, the new fluoroplastic ACTIVENT will be offered in a wide variety of tube designs and sizes (grommets and shank styles) as currently manufactured and distributed in non-antimicrobial vent tubes.

AI/ML Overview

This document describes a 510(k) submission for an Antimicrobial Ventilation (Tympanostomy) Tube and lacks the information required to answer your request.

Here's why:

Medical Device, Not AI/Machine Learning: The submission is for a physical medical device (tympanostomy tube), not a software or AI-driven diagnostic tool.
No AI Performance Metrics: Consequently, there is no mention of acceptance criteria related to AI performance (e.g., sensitivity, specificity, AUC), nor any study describing how an AI device meets such criteria.
No "Test Set," "Training Set," or "Ground Truth" in the AI Sense: These terms are specific to the evaluation of AI models. The document refers to "evaluations of biocompatibility, silver ion leach testing and in vitro evaluations of antimicrobial activity" for the physical device, not data sets for an algorithm.
No Human Reader Studies: Since it's not an AI-assisted diagnostic, there are no MRMC studies or discussions of human reader improvement with AI.

To answer your request, I would need a document describing the performance and evaluation of an Artificial Intelligence or Machine Learning medical device.

Summary

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510(k) Summary Antimicrobial Ventilation (Tympanostomy) Tube

Image /page/0/Picture/2 description: The image shows a handwritten number, K 961873, underlined and circled. The number is written in a simple, clear font, and the circle around it is slightly irregular. The background is plain white, which makes the number stand out. The image appears to be a close-up of the number.

1.0 Date Prepared
UL.

2.0 Submitter (Contact)

May 14, 1996

David Timlin Xomed Surgical Products 6743 Southpoint Drive N. Jacksonville, FL 32216-0980 (904) 279-7532

3.0 Device Name

Proprietary Name: Common Name: Classification Name:

ACTIVENT Antimicrobial Ventilation Tubes Tympanostomv (Ventilation) Tube Tube, Tympanostomy

న్నార Device Classification

This device was classified by the Ear. Nose and Throat Panel as follows: Tube, Tympanostomy 77 ETD Class II 21CFR 874.3880

6.0 Device Description

7.0 Intended Use

The intended use of the fluoroplastic antimicrobial vent tube is identical to the currently marketed silicone ACTIVENT tubes: for prescription use only, as a means of temporary communication of the outer and middle ear to provide ventilation or drainage of the middle ear when inserted through an incision in the tympanic membrane.

8.0 Substantial Equivalence

The fluoroplastic ACTIVENT vent tubes are substantially equivalent to the currently marketed silicone ACTIVENT vent tubes. This statement is supported by the fact that both devices have the same intended use / indications for use and contain the same active ingredient. Evaluations of biocompatibility, silver ion leach testing and in vitro evaluations of antimicrobial activity were conducted to compare the characteristics of the silicone and fluoroplastic antimicrobial vent tubes. This testing demonstrates that the fluoroplastic tubes display biocompatibility and performance characteristics equivalent to the silicone tubes or other in vivo testing are considered unnecessary, as the clinical safety and effectiveness of silver as an antimicrobial additive has already been demonstrated with the silicone base material as reported in K941407/S1. The equivalent performance and biocompatibility of the fluoroplastic and silicone base materials with silver additive, do not raise any new issues of safety or effectiveness that would require clinical evaluation to resolve.

Regulation Number and Section

§ 874.3880 Tympanostomy tube.

(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.