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Pūrgo is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pūrgo is non-sterile.

Pūrgo has been demonstrated to remove the following organisms under the following exposure conditions:

Pūrgo is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria and viruses in air. Pūrgo may be used in medical facilities and commercial home healthcare environments. Pūrgo's main components consist of

• . LED UV-C lamps that generate irradiation to destroy microorganisms that are not filtered:
• . a proprietary SteriDuct chamber that intensifies the UV-C light to destroy microbiological material:
• . a filtration system with pre-filter, activated carbon filter, and HEPA filter;
• . a motor/impeller to move air through the filtration system:
• . sensors to monitor UV irradiance and airflow;
• . an electronic control system to power and control the device; and
• . a touch panel interface equipped with LEDs to indicate the working status of the device.

Pūrgo has several built-in safety features that will prevent operation of the filter cartridge is not in place or if the filter door is not closed. The unit also incorporates UV and airflow sensors that provide warnings to the user if the device is not performing as designed to purify air.

Pūrgo pulls air through a filter cartridge and then passes the filtered air through a chamber containing UV-C light to neutralize remaining airborne microorganisms (such as bacteria, viruses, and fungi). The filter cartridge contains a series of three filters, the first of which is a pre-filter that removes physically large particulate matter (such as dust) and protects the finer particle filters downstream. This is followed by an Activated Carbon filter. Finally, a HEPA (highefficiency particulate air) filter that removes 99.995% of the remaining airborne particles above a particle size of 0.1 µm.

Any microbes that still manage to make it through the filters, pass through the SteriDuct chamber where they are subjected to Ultraviolet Radiation at 265 nm (UV-C). UV radiation at this wavelength is particularly effective at destroying microbes. UV-C irradiation has been shown to damage the microbe's RNA and DNA genetic materials sufficiently to prevent the microbe's ability to reproduce.

After passing through the filtration and SteriDuct UV-C chamber, the purified air then exits back into the room. The exit air does not destroy laminar air flow in a typical operating room environment.

The document describes the acceptance criteria and the studies conducted for the Pūrgo device, a combination UV and air filtration system.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

For the Microorganism Performance testing:

• The device was tested with six different aerosolized biologicals at "normal speed."
• Two of these biologicals (MS2 and Bacillus globigii) were also tested at "sleep" and "boost" fan speeds.
• The document does not specify a numerical sample size (e.g., number of runs, number of devices) for the individual tests, only the types of organisms and conditions.
• The data provenance is from non-clinical testing, performed by AeroClean Technologies, LLC, as "Internal Standards." There is no indication of country of origin for the underlying data samples or whether it was retrospective or prospective, beyond the fact that it was laboratory testing.

For Fractional Efficiency testing:

• Performed on "the Pūrgo filter and the Pūrgo device itself."
• Sample size not explicitly stated for number of filters or devices tested.

For other tests (UV Intensity, UV Irradiance Exposure, Ozone, Airflow Performance Evaluation, Laminar Airflow Evaluation, Home Healthcare Environments, Electrical Safety, Electromagnetic Compatibility, Software Validation), sample sizes are not explicitly stated. The tests are generally described as "testing was performed" or "evaluation was performed."

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

• The document does not specify the number or qualifications of experts used to establish ground truth for any of the test sets.
• All tests are presented as laboratory-based performance evaluations against established standards or internal criteria, rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

• No adjudication method is mentioned as these are performance verification tests against predefined acceptance criteria, not subjective evaluations requiring expert consensus or adjudication.

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

• No MRMC comparative effectiveness study was done or mentioned. The submission focuses on the standalone performance of the device against a predicate, not human reader improvement with or without AI assistance.

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

• Yes, standalone performance was done. All the reported testing, particularly the "Microorganism Performance" and "Fractional Efficiency" tests, represent the standalone performance of the Pūrgo device (algorithm/device only without human intervention in the purification process).

7. The Type of Ground Truth Used

• The ground truth used for performance validation is primarily based on laboratory measurements and adherence to recognized standards (e.g., IEST-RP-CC001.6 for fractional efficiency, ACGIH TLVs for UV exposure, UL 867 for ozone, UL 507 and IEC 60601-1 for electrical safety).
• For microorganism reduction, the "log reduction" figures are derived from measured concentrations of live microorganisms before and after exposure to the device in controlled laboratory settings.

8. The Sample Size for the Training Set

• The Pūrgo device is an air purification device, not an AI or machine learning model that typically requires a "training set." Therefore, this concept does not apply, and no training set sample size is mentioned.

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

• Since the device is not an AI/ML system requiring a training set, this question is not applicable.

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