(58 days)
The Eustachi is indicated for the treatment of negative middle ear pressure.
Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, and hearing loss. The Eustachi provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.
The Eustachi device is a battery-operated device designed to blow a controlled flow of air into the nose to facilitate opening the eustachian tubes. For use, the nosepiece is fitted tightly against one nostril to make an airtight seal. While pinching the other nostril shut, the Eustachi device is activated by pressing and holding the power button. The patient swallows while the device is running, allowing regulated air to move from the nose to the eustachian tube to help open the eustachian tube and equalize pressure in the middle ear.
Eustachi is provided non-sterile, and is designed for reuse with a single patient.
The provided text describes the Eustachi Ear Pressure Relief Device (K203754) and its substantial equivalence to a predicate device. However, it does not include typical acceptance criteria tables or detailed study results that would be used to demonstrate device performance against specific metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance. This type of information is generally found in studies for diagnostic devices or AI-powered medical devices.
The Eustachi device is a non-AI, mechanical device for relieving negative middle ear pressure. Therefore, the information requested regarding AI performance, expert ground truth, MRMC studies, or training set details is not applicable to this device submission.
Here's a breakdown of the available information regarding acceptance criteria and performance studies, addressing as many of the requested points as possible given the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in the way one might expect for a diagnostic or AI device. Instead, "acceptance criteria" are implied by compliance with various standards and successful completion of specific tests. The "reported device performance" is the successful demonstration of this compliance and functionality.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Complies with ISO 10993-1:2018 (FDA recognition # 2-258) and FDA guidance for surface-contact devices (mucosal tissue, |
N/A