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To dilate the cartilaginous portion of the Eustachian tube for treating tube dysfunction in patients 18 years and older using a transnasal approach.

The Audion ET dilation system (ET is an abbreviation for Eustachian tube) is intended to dilate the Eustachian tube through use of balloon dilation and a transnasal approach. It contains a dilation device, inflation device and inflation lock. The dilation device has a 1.26 mm outer diameter (OD) curved non-malleable shaft with a balloon fixed at the distal end and a 1.91 mm atraumatic polymer ball tip. The dilation device is positioned under endoscopic visualization with the balloon fully retracted. Once the portion of the device from the ball tip to the base of the curve is seated in the Eustachian tube, the balloon is advanced and then inflated. The deployed balloon angle of the dilation device is 45° for optimal treatment of the Eustachian tubes. The distal leg length with balloon extended is 18.5 mm. When the balloon is inflated to 12 atm, the balloon diameter is 6mm and the body length is 20 mm.

The inflation device is an accessory that consists of an inflation syringe and an extension line. The inflation device is designed to deliver a pressure of 12 atm and is used to inflate the balloon on the dilation device.

The inflation lock is an optional accessory that is intended to interface with the Audion dilation device, inflation syringe and extension line connections to hold or release pressure during balloon dilation.

The Audion ET dilation system is provided sterile and is for single patient use only. The dilation device, inflation device and inflation lock are sterilized using ethylene oxide.

The Audion ET dilation system has been tested to withstand multiple inflations in a surgical case

The provided text is a 510(k) summary for the Audion ET dilation system, a medical device for dilating the Eustachian tube. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on diagnostic performance (like an AI/imaging device).

Therefore, many of the requested categories (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this document, as they pertain to studies typically performed for AI or diagnostic imaging devices to prove efficacy/accuracy.

This document describes the device itself, its intended use, and its technological characteristics in comparison to a predicate device, along with bench testing to demonstrate performance as intended and meeting design specifications.

Here's what can be extracted and addressed:

1. A table of acceptance criteria and the reported device performance:

The document does not present acceptance criteria in a table format with corresponding quantitative performance metrics related to diagnostic accuracy or clinical outcomes. Instead, it states that "Performance testing showed that the device meets design specifications and performs as intended." The "acceptance criteria" here are implied to be the successful completion of various bench tests demonstrating the device's functionality, safety, and compatibility with its intended use, and substantial equivalence to the predicate.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable in the context of diagnostic data. The "test set" here refers to physical devices or components subjected to bench testing. The document does not specify the number of units tested for each specific bench test (e.g., how many devices were tested for strength, or how many packaging samples for integrity).
• Data Provenance: The tests are described as "bench testing" and "performance testing," which typically occur in a lab setting. There's no mention of country of origin for clinical data (as there was no clinical study described for efficacy) or whether it was retrospective or prospective. HFE/UE verification involved "ENT physicians."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified. The document mentions "ENT physicians" were involved in "HFE/UE verification testing" and "design validation." Their role seems to be evaluating the usability and design effectiveness, rather than establishing a "ground truth" for a diagnostic task.
• Qualifications of Experts: "ENT physicians." No further detail (e.g., years of experience, board certification) is provided.

4. Adjudication method for the test set:

Not applicable. There was no clinical study with a "ground truth" requiring adjudication. The document describes bench testing and usability verification, not multi-reader diagnostic interpretation.

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:

Not applicable. This is not an AI or diagnostic imaging device submission.

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

Not applicable. This is not an AI or diagnostic imaging device submission.

7. The type of ground truth used:

Not applicable in the context of diagnostic ground truth. The "ground truth" for this device's performance is its ability to meet engineering specifications (e.g., balloon diameter at a certain pressure, shaft strength, sterilization efficacy), which are verified through various physical and chemical tests.

8. The sample size for the training set:

Not applicable. There is no AI component requiring a training set.

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

Not applicable. There is no AI component.

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