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K Number
K961873
Device Name
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
Manufacturer
XOMED, INC.
Date Cleared
1996-07-01

(47 days)

Product Code
ETD
Regulation Number
874.3880
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

§ 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.