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The Airgle Room Air Purifier is a free standing, air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria and virus in medical facilities and occupied spaces.

The Airgle® Air Purifier has been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter of the subject device in the following exposure/working conditions:

Airgle Room Air Purificr is an air purification device that employs an ultraviolet air purification technology to inactivate viral aerosols. It is a free-standing device, which has a sealed main housing including a Carbon filter, a cHEPA filter and Titanium Pro (UV-C) module. Model AG300 use a 2-in-1 filter which combine the Carbon filter and cHEPA filter.

The operation of the device is as follows:

1. Room air is drawn into the device via the rear grill.
2. The process begins when air moves through the Carbon filter, which captures the large particles
3. Next, the air moves through the cHEPA filter, which captures a particle size greater than 0.3 microns. The filter is an ultra-high performance cHEPA filter, which filters respirable particulate matter with an efficiency reaching 99.3% at least.
4. Then the air moves through the Titanium Pro® module, where viral organisms are inactivated by UV-C light.
5. Purified air is then returned to the room via the front grill.

The Airgle Room Air Purifier (Models AG300, AG600, AG900) is a medical ultraviolet air purifier designed to inactivate indoor airborne aerosols, including bacteria and viruses, in medical facilities and occupied spaces. The device's performance was assessed through non-clinical testing to demonstrate its ability to destroy MS2 bacteriophage bioaerosols.

Here's an overview of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical laboratory testing. The sample size for the "Bacteriophage Test" is not explicitly stated as a number of devices or runs within the provided text. However, the results indicate testing was performed for each model (AG300, AG600, AG900).

The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from laboratory testing conducted as part of the device's clearance process. The studies were retrospective in the sense that they were designed to evaluate the finalized product against pre-defined criteria.

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

This document describes non-clinical performance testing (e.g., viral inactivation, filter efficiency, electrical safety), not a study involving human experts establishing ground truth from medical images or clinical observations. Therefore, this section is not applicable in the context of this device's non-clinical evaluation. The "ground truth" here is established by the well-defined scientific and engineering standards and methodologies for air purification testing.

4. Adjudication Method for the Test Set

Not applicable, as this was non-clinical laboratory testing rather than a study requiring expert adjudication of data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an air purifier, and its efficacy is measured by its ability to inactivate pathogens and filter air, not by its impact on human reader performance in interpreting medical data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance data presented is inherently "standalone" in this context. The device (Airgle Room Air Purifier) is the "algorithm" or system being evaluated for its direct efficacy in air purification, without human intervention in its primary function of germicidal UV light and filtration. The reported log reduction of viral load and filter efficiency are direct measurements of the device's standalone performance.

7. The Type of Ground Truth Used

The ground truth for the performance claims (e.g., viral inactivation) was established through laboratory testing using scientifically recognized and standardized methods.

• MS2 Bacteriophage: A widely accepted surrogate virus for airborne viral studies due to its non-pathogenic nature and environmental robustness.
• ANSI/ASHRAE Standard 52.2: A standard method for testing general ventilation air-cleaning devices for removal efficiency by particle size.
• IEC 60601-1, IEC 60601-1-2, AAMI TIR69:2017, ANSI C63.27-2017: Industry standards for electrical safety, electromagnetic compatibility, and wireless coexistence.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation (testing) of a physical device. There is no mention of a "training set" in the context of an AI/ML algorithm being developed. The device's design and engineering would be based on established scientific principles and materials, not a data "training set."

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

Not applicable, as there is no "training set" in the context of this device's validation.

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