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The Aerogen USB Controller System includes the Aeroneb® Professional and Aeroneb® Solo Nebulizers, which are intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.

The Aeroneb® Professional Nebulizer is intended for multiple patient use in hospital environment and single patient use in home environment. Aeroneb® Solo Nebulizer is for single patient use. Both nebulizers are for pediatric (29 days or older) and adult patients.

The Aerogen USB Controller System includes the previously cleared Aeroneb® Professional and Solo Nebulizers. The Aerogen USB Controller is an alternative controller to the existing Aeroneb® Pro and Aeroneb® Pro-X Controllers. The power source for the Aerogen USB Controller is the Aerogen USB AC/DC Adapter.

The Aerogen USB Controller System utilises the following components:

• Aeroneb® Pro or Solo Nebulizers
• Aerogen USB Controller
• T-Piece
• AC/DC Adapter and Clips

The Aerogen USB Controller can be used to power the Aeroneb® Pro and Solo nebulizers in both the hospital and homecare environments. For homecare use, it is operated on vent only.

The Aerogen USB Controller provides two modes of operation; a 30 minute and a 6 hour nebulization cycle. The particular mode to be used depends on the accompanying nebulizer. The Aeroneb Pro® nebulizer can be used in the 30 minute intermittent mode only, whereas the Aeroneb® Solo nebulizer can be used in both the 30 minute intermittent and 6 hour modes.

The medical device in question is the Aerogen USB Controller System, which comprises the Aerogen USB Controller and the existing Aeroneb® Professional and Aeroneb® Solo Nebulizers. The study described focuses on demonstrating the substantial equivalence of the new Aerogen USB Controller to previously cleared controllers for the nebulizers.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample size for the cascade impaction testing, nor does it detail the provenance of the data in terms of country of origin or whether it was retrospective or prospective. It mentions "cascade impaction testing was performed: using an Aeroneb Pro nebulizer and an Aeroneb Solo nebulizer with a USB Controller and one drug - Salbutamol Sulphate (Albuterol)." This suggests a controlled laboratory test setup rather than clinical data from human subjects.

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

This information is not provided in the document. The "ground truth" for the performance testing (specifically MMAD) was laboratory measurement using an 8-stage Andersen Cascade Impactor (ACI) against a predefined specification range. This is an objective measurement rather than expert consensus on subjective data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As noted above, the primary performance criteria (MMAD) were determined through objective laboratory measurement using a device (8-stage Andersen Cascade Impactor), not through expert review requiring adjudication.

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

An MRMC comparative effectiveness study was not performed. This device is a nebulizer controller, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

A standalone performance evaluation was performed for the device's functional characteristics. The cascade impaction testing (MMAD droplet size and other aerosol characteristics) evaluated the nebulizer's performance with the new USB controller in a laboratory setting, independent of human interaction beyond operating the device for the test. The electrical safety and EMC testing were also standalone assessments of the device's compliance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the primary performance characteristic (MMAD Droplet Size) was based on objective laboratory measurements using an 8-stage Andersen Cascade Impactor against a pre-defined and scientifically accepted specification range (1 to 5 µm). For electrical safety and EMC, the ground truth was compliance with recognized international standards. For software, it was adherence to FDA guidance and a consensus standard (IEC 62304:2006).

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The Aerogen USB Controller System is a hardware device with associated software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software" section refers to a Level of Concern Assessment and Safety Classification, meaning the software development followed established, verified engineering practices, not a machine learning training paradigm.

9. How the Ground Truth for the Training Set was Established

This information is not provided and is not applicable as there was no AI/ML training set. The "ground truth" for the software's safety and level of concern was established by adherence to FDA guidance (2005 FDA Guidance) and an international consensus standard (IEC 62304:2006) for software development in medical devices.

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