Search Results

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.

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.

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.

Ask a specific question about this device