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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:

| Organism | Name | Avg. max log reduction / exposure
time (min) |
|-----------------|-----------------------------------------------------|-------------------------------------------------|
| Gram + Bacteria | Methicillin resistant Staphylococcus
epidermidis | 4.6 (45) at normal speed |
| Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed |
| Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed |
| RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed |
| RNA Virus | SARS-CoV-2 | 4.2 (60) at normal speed |
| DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed |
| Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |

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 funqi). 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.

This document describes the acceptance criteria and the study proving the device meets these criteria for the Purgo™ UV and air filtration device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text details the performance testing for the Purgo™ device, specifically for its aerosolized biological reduction capabilities, filtration efficiency, UV intensity, and other safety/performance metrics.

• Microorganism Performance Testing: The testing was performed on the Purgo™ device. For each microorganism, the "Avg. max log reduction / exposure time" is reported, implying multiple runs or sufficient measures to establish an "average maximum log reduction." The exact sample size (number of devices tested or number of repetitions per test) is not explicitly stated as a numerical count (e.g., "n=X devices"). The data provenance is internal testing ("Internal Standards"). The document does not specify the country of origin of the data, nor whether it was retrospective or prospective. It is implied to be a prospective laboratory study for device validation.

• Other Tests (Fractional Efficiency, UV Intensity, Ozone, Airflow, Electrical Safety, EMC, Software Validation): These tests were conducted on the Purgo™ device. Similar to microorganism performance, the exact sample size (number of devices/filters tested) is not explicitly stated. These also appear to be prospective laboratory studies conducted by the manufacturer or a contracted testing facility.

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

The document describes performance testing of a physical device against biological agents and engineering standards. It does not involve interpretation of medical images or patient data that would typically require expert radiologists or other clinical experts for ground truth establishment.

• Microorganism Performance: The "ground truth" for the efficacy data points (log reduction) is established by quantitative laboratory measurements of aerosolized biologicals before and after exposure to the device. This is a direct measurement of the device's performance, not an expert consensus on a medical finding. The qualifications of the personnel conducting these highly specialized microbiological and engineering tests are not provided in this document.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of data points (e.g., radiological reads). The results are direct measurements from laboratory and engineering tests.

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

No. An MRMC comparative effectiveness study is typically relevant for AI/CADe systems that assist human readers in interpreting medical images. This document describes the performance of an air purification device, which does not involve human readers interpreting cases. Therefore, there is no mention of human readers improving with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in the sense that the device's performance (purification of air) is evaluated independently without human intervention during its operation. The performance metrics (log reduction, filtration efficiency, etc.) describe the device's inherent capabilities. This is a standalone device performance study, not a standalone algorithm study (as it's not an AI/software-only device).

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

• Quantitative Laboratory Measurements: For microorganism reduction, validated laboratory methods were used to quantify the reduction in viable biological agents.
• Established Engineering Standards and Test Methods: For aspects like fractional efficiency, UV intensity, ozone emissions, electrical safety, EMC, and airflow performance, the device was tested against recognized industry and regulatory standards (e.g., IEST-RP-CC001.6, ACGIH, UL 867, UL ECVP 2998, IEC 60601 series). Compliance with these standards serves as the ground truth for these parameters.
• Computational Fluid Dynamics (CFD) Analysis: For laminar airflow evaluation, CFD was used to model and predict the device's impact on airflow, which is a form of simulated "ground truth" based on physics.

8. The Sample Size for the Training Set

Not applicable. This device is a physical air purification system and does not employ machine learning or AI algorithms that would require a "training set" of data in the typical sense (e.g., for image recognition, natural language processing). Its design and performance are based on established engineering principles of UV germicidal irradiation and HEPA filtration.

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

Not applicable, as there is no training set for an AI/ML algorithm. The device's efficacy is based on its physical and mechanical design and the known properties of UV-C light and HEPA filtration.

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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

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