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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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench Testing" and "Usability Testing" as performance data.

• Bench Testing: No sample size is specified for dimensional, pressure, flow rate, or drop tests. These are typically engineering tests performed on a limited number of manufactured units.
• Usability Testing: The document states "A study was conducted... to verify the ability of potential users to complete the following tasks..." The sample size for this usability study is not provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). Usability studies are typically prospective tests with a representative user group.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The Eustachi device is a mechanical device for therapeutic intervention, not a diagnostic device requiring expert interpretation for ground truth. Ground truth in this context is based on engineering specifications and user comprehension of instructions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not directly applicable. For engineering tests like bench testing, results are typically compared against pre-defined specifications without an "adjudication method" involving multiple human reviewers in the way it's used for AI or diagnostic studies. For usability testing, user performance and feedback are assessed against criteria, but a specific "adjudication method" like 2+1 or 3+1 is not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those incorporating AI, where the performance of human readers (e.g., radiologists) with and without AI assistance is evaluated across multiple cases. The Eustachi is a non-AI mechanical device for therapeutic use.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done. The Eustachi device is a mechanical device and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the Eustachi device's performance studies is based on:

• Engineering Specifications: For bench tests (pressure, flow rate, dimensions).
• Recognized Standards: For biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), cleaning validation (AAMI TIR30), and usability (IEC 62366-1, IEC 60601-1-6).
• User Comprehension and Performance: For usability testing, where users' ability to follow instructions and correctly operate the device indicates effective design and labeling.

8. The sample size for the training set

This question is not applicable. The Eustachi device is not an AI/machine learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established

This question is not applicable as there is no training set for this mechanical device.

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