Search Results

Ventilation tubes are indicated where cases of enstachian tube dysfunction fails to respond conventional therapy. This includes : Chronic otitis Media with effusion (serous , mucoid, or pur ulent). Recurrent acute ofitis Media . persistent high negative A record of with associated middle ear pressure, hearing conductive Symptomatic otalgia, vertige and for timmitas brangia, version of the tympanic membraine.

Tympanostomy Ventilation Tube-TVT 800

The provided text is a 510(k) premarket notification letter from the FDA regarding a Tympanostomy Ventilation Tube (TVT 800). It is a regulatory document addressing the substantial equivalence of this medical device.

This document does NOT contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies. It is a regulatory approval letter, not a device performance study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document confirms that the device is "substantially equivalent" to legally marketed devices, but it does not detail the specific performance metrics or studies used to determine this equivalence.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device