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The AireHealth™ Nebulizer electronic vibrating mesh nebulize liquid medications for inhalation by a patient. The AireHealth™ Nebulizer may be used in adults or children 5 years of age and older. The AireHealth™ Nebulizer is a portable Nebulizer for use in and out of the home environment.

The AireHealth™ Nebulizer is not intended as a life sustaining or life-supporting device.

The AireHealth™ Nebulizer is not intended for use with Pentamidine.

The AireHealth" Nebulizer, model AH-04, is a portable electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient in and out of the home environment. The Nebulizer may be used in adults or children 5 years of age and older.

The AireHealth™Nebulizer vibrating mesh nebulizer incorporates a piezoelectric transducer that vibrates at a nominal frequency (115kHz) when electrical current is applied. The vibration of the transducer is transmitted to a metal alloy mesh vapor disk that contains approximately 5,000 holes that are in contact with the liquid to be nebulized. An electrical charge applied to the piezoelectric transducer, in turn, leads to vibration (inward and outward movement of the mesh vapor disk), passing the liquid through the holes to form an aerosol. The AireHealth™ Nebulizer is battery operated. The handset in the AireHealth 100 Nebulizer has a use life of 3 years.

Liquid medication is placed in the medicine cup which should be cleaned after every use. The medicine cup should be replaced every 90 days.

The Nebulizer is capable of providing use and status information to a companion application wirelessly via Bluetooth connection. The companion application is an optional accessory for displaying purposes only and will not allow operation or control of the nebulizer. The companion application is not a medical device.

This document describes the AireHealth™ Nebulizer, a device that nebulizes liquid medications for inhalation. It primarily focuses on demonstrating substantial equivalence to a predicate device, the MicroVapor Devices POCKET NEB (K142541), rather than presenting a study proving that the device meets specific acceptance criteria with associated performance metrics.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types is largely not available in the provided text. The document details non-clinical testing to support substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state a table of acceptance criteria with corresponding device performance metrics in the format you requested for a novel device proving its own performance. Instead, it demonstrates performance through various non-clinical tests to show substantial equivalence to a predicate device.

However, some performance parameters are mentioned in the "Comparison of Technological Characteristics" and "Performance Testing - Bench" sections:

Note: The "Acceptance Criteria" column above is inferred from the predicate device's specifications or stated requirements for the proposed device.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated for each test. For "Use Life Testing for Medication Cup and Handset," it states "these components were subjected to continuous use, equivalent to maximum possible use during a 3-year and 90-day period." This implies functional testing over time on a device or components, but the number of units tested is not specified.
• Data Provenance: The testing appears to be internal bench testing ("Performance Testing - Bench") conducted by MicroVapor Devices (for biocompatibility and potentially other aspects leveraged by AireHealth Inc.) or AireHealth Inc. itself. There is no indication of country of origin for specific test data, and it is entirely retrospective as it's part of a 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. The document does not describe a study involving expert-established ground truth for a test set, as this is a medical device hardware submission, not an AI/software diagnostic tool requiring such validation.

4. Adjudication Method for the Test Set:

Not applicable, for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement:

No, an MRMC comparative effectiveness study was not done. This device is a nebulizer, not an AI-assisted diagnostic or treatment system involving human readers.

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 device is a physical nebulizer, and while it has optional Bluetooth connectivity to a companion application, the application is explicitly stated as "an optional accessory for displaying purposes only and will not allow operation or control of the nebulizer. The companion application is not a medical device." Therefore, there is no AI algorithm performing a medical function in standalone or human-in-the-loop mode.

7. The Type of Ground Truth Used:

For the performance tests described (e.g., nebulization rate, use life), the "ground truth" would be objective measurements in a laboratory setting against established engineering or performance specifications. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. There is no AI algorithm being trained, so no training set is relevant.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the same reasons as point 8.

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