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The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation.

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2 - a non-enveloped ssRNA virus, Phi-X174 - a non-enveloped ssDNA virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores entrained on the filter under the following exposure conditions:

| Organism | Name | Average Maximum Log Reduction / Exposure Time
(hours) by Temperature | | |
|------------------------|-------------------------------|-------------------------------------------------------------------------|------------------|------------------|
| | | 45°F | 72°F | 110°F |
| Bacteria | Staphylococcus
epidermidis | 4.94 / 12 hours | 4.54 / 4 hours | 4.51 / 4 hours |
| Bacteria | Klebsiella aerogenes | 5.40 / 1 hour | 6.55 / 1 hour | 6.54 / 1 hour |
| Virus | MS2 bacteriophage | 4.32 / 12 hours | 4.51 / 4 hours | 4.58 / 4 hours |
| Virus | Phi-X174 bacteriophage | 4.39 / 12 hours | 5.24 / 4 hours | 5.14 / 4 hours |
| Mold endospore | Aspergillus brasiliensis | 4.52 / 168 hours | 5.61 / 168 hours | 5.61 / 168 hours |
| Bacterial
endospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours |

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2, Phi-X174, Aspergillus brasiliensis, and Bacillus subtilis in a large chamber (9.1 ft x 9.1 ft x 7 ft) at a flow rate of 500 cfm (cubic feet per minute):

| Organism | Name | Average Net Log Reduction
in 20 Minutes |
|---------------------|----------------------------|--------------------------------------------|
| Bacteria | Staphylococcus epidermidis | 5.17 |
| Bacteria | Klebsiella aerogenes | 5.56 |
| Virus | MS2 bacteriophage | 5.00 |
| Virus | Phi-X174 bacteriophage | 5.34 |
| Mold endospore | Aspergillus brasiliensis | 4.50 |
| Bacterial endospore | Bacillus Subtilis | 4.58 |

The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a medical ultraviolet air purifier, which incorporates patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-fiter, UV-A lamps, and a catalytic filter coated with a photocatalyst. The ViroZap™ has metal housing with electronic controls, and it is installed in the ducts of a building's HVAC system.

It will be available in two sizes: one size with outer dimensions of 28.5 inches by 12.25 inches, and a second size with outer dimensions of 24 inches by 12.25 inches. The ViroZap 110 device has a pre-filter and a chamber equipped with 6 low energy ultraviolet LED lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.

The device in question is the ViroZap™ Indoor Air Purifier, In Duct Model 1008.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is evaluated against its effectiveness in reducing various microorganisms both when entrained on the filter and in a large chamber setting. The acceptance criterion for both main studies (room air reduction and kill rate kinetics) was that the device's effectiveness should be "equivalent or superior to the predicate, Transformair (K161468)." The documentation confirms that this criterion was met, showing the device was effective in reducing the microorganisms.

Specific log reduction data (Average Net Log Reduction in 20 Minutes) for chamber testing are:

• Staphylococcus epidermidis: 5.17
• Klebsiella aerogenes: 5.56
• MS2 bacteriophage: 5.00
• Phi-X174 bacteriophage: 5.34
• Aspergillus brasiliensis: 4.50
• Bacillus Subtilis: 4.58 |
  | In vitro study to characterize the temperature variant kill rate kinetics for six different bioaerosols deposited on the surface of the subject device's photocatalytic coated filter media after exposure to UV-A light. | Confirmation that the kill kinetics of the modified catalytic filter was equivalent or superior to the predicate device catalytic filter. | Pass. As with the predicate device, the filter media achieved more than a 4.0 log reduction in each species at each temperature.

Specific log reduction data (Average Maximum Log Reduction / Exposure Time) entrained on filter are:
45°F
-- Staphylococcus epidermidis: 4.94 / 12 hours
-- Klebsiella aerogenes: 5.40 / 1 hour
-- MS2 bacteriophage: 4.32 / 12 hours
-- Phi-X174 bacteriophage: 4.39 / 12 hours
-- Aspergillus brasiliensis: 4.52 / 168 hours
-- Bacillus Subtilis: 4.83 / 168 hours
72°F
-- Staphylococcus epidermidis: 4.54 / 4 hours
-- Klebsiella aerogenes: 6.55 / 1 hour
-- MS2 bacteriophage: 4.51 / 4 hours
-- Phi-X174 bacteriophage: 5.24 / 4 hours
-- Aspergillus brasiliensis: 5.61 / 168 hours
-- Bacillus Subtilis: 4.21 / 168 hours
110°F
-- Staphylococcus epidermidis: 4.51 / 4 hours
-- Klebsiella aerogenes: 6.54 / 1 hour
-- MS2 bacteriophage: 4.58 / 4 hours
-- Phi-X174 bacteriophage: 5.14 / 4 hours
-- Aspergillus brasiliensis: 5.61 / 168 hours
-- Bacillus Subtilis: 4.34 / 168 hours |
| Test to evaluate the efficacy of filter media following accelerated aging equivalent to one year. | Confirmation that the subject device had equivalent performance after accelerated aging equivalent to one year. | Pass. The subject device was effective at reducing the microorganism after undergoing accelerated aging, with results equivalent to trials run on the unaged device. |

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

The document does not explicitly state the numerical sample sizes (e.g., number of test runs or replicates) for the validation studies. It describes the methodology:

• Room Air Reduction Study: "Six microorganism species were aerosolized in a sealed bioaerosol chamber containing the subject device. Bioaerosol samples were taken at multiple time points throughout each trial..."
• In vitro Kill Rate Kinetics: "Samples of the subject device's photocatalytic coated filter media were tested against six aerosolized microorganisms. The samples were tested at three different temperatures." "The trials were carried out to quantify at least a 4.0 log reduction."

The data provenance is not specified in terms of country of origin. The studies appear to be prospective as they involved testing the physical device and its components under controlled laboratory conditions to demonstrate performance.

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

This information is not provided in the document. The "ground truth" for this medical device is established through quantitative laboratory measurements of microorganism reduction, not through expert consensus or interpretation of medical images. Therefore, the concept of "experts establishing ground truth" in the typical sense of a clinical or imaging study is not directly applicable here. The credibility of the results relies on standard microbiology and biodefense testing protocols, and the expertise of the laboratory personnel conducting these tests.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are laboratory-based performance tests, not studies involving human interpretation or adjudication of results in a clinical context. The results are quantitative measurements of microbial reduction.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human readers (e.g., radiologists interpreting images). The ViroZap™ is an air purification device, and its performance is evaluated by its physical ability to destroy microorganisms, not by assisting human decision-making.

6. Standalone (Algorithm Only) Performance

This concept is not applicable to this device. The ViroZap™ is a physical medical device (an air purifier) that works mechanically and photochemically, not an algorithm or software-only device. Its performance is inherently "standalone" in the sense that its efficacy stems from its own physical operation, without human-in-the-loop performance in its primary function of air purification.

7. Type of Ground Truth Used

The ground truth used is based on quantitative microbiological laboratory assays. This involves measuring the reduction of specific microorganism concentrations (Staphylococcus epidermidis, Klebsiella aerogenes, MS2 bacteriophage, Phi-X174 bacteriophage, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores) after exposure to the device or its components under controlled conditions. The "log reduction" values represent the quantitative proof of the device's efficacy.

8. Sample Size for the Training Set

This information is not applicable. The ViroZap™ is a physical device, not an AI/ML algorithm that requires a "training set" of data. Its design and physical properties (e.g., UV-A lamps, catalytic filter) are engineered to achieve the desired microbial destruction.

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

This information is not applicable as there is no "training set" for a physical device like the ViroZap™. The device's performance is demonstrated through its functional capabilities, measured in the non-clinical testing.

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AirKEE T900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacterial, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.

AirKEE T900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions:

AirKEE T900 is a mobile medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE T900 is controlled via a touchscreen control panel on the machine.

AirKEE T900's main components consist of:
Multi-stage air treatment

• a filtration system with primary filter, medium efficiency filter, HEPA filter, activated O carbon filter, and nano-material filter
• UV lamps that generate UV-C irradiation to eliminate microorganisms о
• o a motor/impeller to move air through the filtration system

System control

• o an electronic control system to power and control the device
• a touch panel interface to indicate the working status of the device and consumables O

AirKEE T900's multi-stage air treatment: Air enters through the bottommost chamber and passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through modified activated carbon and patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Lastly, HEPA H14 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top of the machine.

The touch panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.

The provided FDA 510(k) notification describes the AirKEE T900, a medical ultraviolet air purifier, and its performance. It outlines the device's indications for use and presents a summary of non-clinical tests to demonstrate its effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

• Staphylococcus albus: Log 4 (99.99%) reduction in 60 minutes at high fan speed; Log 4 (99.99%) in 120 minutes at low fan speed
• Escherichia coli: Log 4 (99.99%) reduction in 60 minutes at high fan speed; Log 4 (99.99%) in 120 minutes at low fan speed
  Mold:
• Penicillium rocqueforti: Log 4 (99.99%) reduction in 60 minutes at high fan speed
• Aspergillus Niger: Log 4 (99.99%) reduction in 120 minutes at low fan speed
  Virus:
• Influenza A virus, H1N1: Log 4 (99.99%) reduction in 60 minutes at high fan speed
• Influenza A virus, H3N2: Log 4 (99.99%) reduction in 120 minutes at low fan speed |
  | Fractional Efficiency | Per Standard particles | Filter fractional efficiency percentage of 99.99% at 0.1-0.2µm |
  | Electrical Safety and EMC | Per Standard | Pass |
  | Ozone | Per Standard (less than 0.05 ppm) | Testing demonstrates the AirKEE T900 unit is able to operate at less than 0.05 ppm at its highest fan speed. |

Note: The term "acceptance criteria" is derived directly from the "Acceptance Criteria" column in the provided table.

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

The document does not specify the sample size for the test set in terms of the number of individual devices tested or the number of replicates for each microbiological test. The provenance of the data is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, beyond "Internal Standards" for microorganism performance. These are non-clinical laboratory tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This document describes non-clinical performance testing of a physical device (air purifier) for its ability to filter and destroy microorganisms and to meet safety standards. It does not involve interpretation of medical images or diagnostic outputs that would typically require human experts to establish "ground truth" in the context of an AI/human reader study. Therefore, the concepts of "number of experts" and "qualifications of those experts" are not applicable to the studies described.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments, typically in diagnostic or imaging contexts. Since the described studies are non-clinical laboratory performance tests (e.g., measuring log reduction of microorganisms, filter efficiency, electrical safety), adjudication methods are not applicable.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic devices where the AI's impact on human reader performance is evaluated. The AirKEE T900 is an air purification device, and its performance is assessed through laboratory-based efficacy and safety tests, not through human reader interpretation of data or images.

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

Yes, the studies described are essentially "standalone" performance evaluations of the device itself, without human-in-the-loop interaction in the context of a diagnostic or interpretive task. The performance metrics (e.g., log reduction of microorganisms, filter efficiency, ozone levels) are direct measurements of the device's function.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations is established through:

• Quantitative Microbiological Assays: For microorganism performance, the "ground truth" is the measured reduction in viable microorganisms (bacteria, mold, viruses) under specific test conditions. This is an objective, laboratory-derived measurement.
• Physical Measurements and Engineering Standards: For fractional efficiency, electrical safety, and ozone release, the "ground truth" is defined by adherence to established industry standards (IEST-RP-CC001.6, UL 507, IEC 60601-1-2, UL 867) and direct physical measurements confirming compliance.

8. The Sample Size for the Training Set

This document details non-clinical performance and safety testing of a manufactured device, not a machine learning or artificial intelligence (AI) algorithm. Therefore, the concept of a "training set sample size" is not applicable, as there is no AI model being trained.

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

As noted above, this pertains to a physical medical device, not an AI model. Therefore, the concept of a "training set" and "established ground truth for the training set" is not relevant to this submission. The device's performance is based on its physical and functional design, which is validated through the non-clinical tests described.

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AirKEE P900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacteria, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.

AirKEE P900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions:

AirKEE P900 is a mobile multi-function medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE P900 is controlled via a touchscreen control panel on the machine.

AirKEE P900's main components consist of:

Multi-stage air treatment

• a filtration system with primary filter, HEPA filter, activated carbon filter, and nano- O material filter
• UV lamps that generate UV-C irradiation to inactivate and eliminate microorganisms o
• a motor/impeller to move air through the filtration system o

System control

• o a touch panel interface to indicate the working status of the device and consumables
  AirKEE P900's multi-stage air treatment: Air enters through the bottommost chamber and fans direct the air in an upwards manner. Firstly, air passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Air then passes through activated carbon filter. Lastly, HEPA H13 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top in an upwards manner.

The control panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.

The AirKEE P900 is a medical ultraviolet air purifier that was tested to demonstrate its effectiveness in capturing and destroying bacteria, mold, and viruses in the air.

Here's an analysis of the acceptance criteria and study information provided:

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 specific sample size for each microorganism performance test (e.g., how many runs were performed for each microorganism). However, it does specify that the tests were conducted "in a 20m³ chamber" and "entrained on the filter of the subject device."

The data provenance is not explicitly mentioned as a country of origin. The submitter is "HealKee Medical Pte Ltd" from Singapore, suggesting the testing might have been conducted in Singapore or a location associated with the company's operations. The data appears to be prospective, as it describes tests conducted specifically for the AirKEE P900 device to demonstrate its performance against predefined criteria.

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 performance evaluation for microorganism reduction and other non-clinical tests likely relied on established laboratory protocols and standards, rather than expert consensus on individual "cases" in the typical sense of diagnostic imaging. For a medical UV air purifier, the "ground truth" would be the measurable reduction of microorganisms.

4. Adjudication Method for the Test Set:

This information is not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretations (e.g., radiologists reviewing images) to establish a consensus ground truth. For a device like an air purifier, performance is measured quantitatively through laboratory tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not done. This type of study assesses the performance of human readers, with and without AI assistance, which is not relevant for an air purifier.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

For the microorganism performance, the study can be considered a standalone performance study of the device (AirKEE P900) operating independently. The device's ability to destroy microorganisms is measured directly in a controlled environment without human intervention during the process itself (though humans operate and set up the device and tests).

7. Type of Ground Truth Used:

The ground truth used for the microorganism performance is quantitative laboratory measurement (direct bacterial/viral/mold count reduction). This involves culturing and counting microorganisms before and after exposure to the device in a controlled chamber, and computing the log reduction.

For fractional efficiency, electrical safety, EMC, and ozone, the ground truth is established by conformance to recognized standards (IEST-RP-CC001.6, UL 507, IEC 60601-1-2, UL 867).

8. Sample Size for the Training Set:

This information is not applicable. The AirKEE P900 is an electromechanical device with filtration and UV-C technology, not an AI/ML-driven diagnostic or analytical tool that requires a "training set" of data in the typical sense for algorithm development. Its performance is based on its physical design and operation, which are then tested for efficacy.

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

This information is not applicable, as there is no "training set" for this type of device. The device's design principles and expected performance are based on established scientific principles of filtration, UV-C radiation, and photocatalysis. The validation occurred through the non-clinical tests described.

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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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The Synexis Sphere Rx is a stand-alone air purifier device intended for medical purposes and is used for the reduction of bacteria and viruses in the air. The device is intended for use in professional healthcare environments. The Sphere Rx is not intended for use near HF surgical equipment or MRI settings.

The Synexis Sphere Rx air purifier demonstrated a ≥ 4 log reduction of bacteria and viruses under the following exposure/ working conditions:

The Synexis Sphere Rx is a photocatalytic air purifier that utilizes a photocatalytic oxidation purification process involving a light-activated catalyst which reacts with organic pollutants to oxidize them. The Sphere Rx draws ambient air through multiple filters including a carbon filter, a MERV filter and a photocatalytic filter that Synexis refers to as a 'Sail'.

When the ambient air containing oxygen and water molecules contacts the photocatalytic filter exposed to UV light, a chemical reaction is initiated inside the device that generates hydroxyl radicals, super oxides and hydrogen peroxides. Synexis refers to the hydrogen peroxide molecules as dry hydrogen peroxide or DHP to distinguish these molecules from the aqueous form of hydrogen peroxide.

The mechanism of action for the Sphere Rx photocatalytic air purifier to reduce microorganisms, including bacteria and viruses, in the air for small room environments relies on combination of capture and destruction. Ambient air is continuously circulated through MERV and carbon filters and a photocatalytic medium under UV light exposure inside the device to achieve a 4 log reduction.

Here's a breakdown of the acceptance criteria and study information for the Synexis Sphere Rx, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

• K. aerogenes (Gram- bacteria): 4.25 log reduction in 240 minutes
• S. epidermidis (Gram+ bacteria): 4.19 log reduction in 360 minutes
• MS2 bacteriophage (Virus): 4.55 log reduction in 300 minutes

Low Fan Speed:

• K. aerogenes (Gram- bacteria): 4.25 log reduction in 240 minutes
• S. epidermidis (Gram+ bacteria): 4.13 log reduction in 480 minutes
• MS2 bacteriophage (Virus): 4.11 log reduction in 480 minutes | Yes |
  | Air Composition Safety (Gases) | Emissions do not exceed permissible exposure limits for: H2O2 gas (≤ 5.8 ppb), O3 (≤ 0.05 ppm), SO2 (≤ 2 ppm), CO (≤ 35 ppm), NO2 (≤ 1 ppm), CH2O (≤ 0.016 ppm), Total VOCs (≤ 1.4 ppm). | Reported Results:
• H2O2 gas: PASS
• O3: PASS
• SO2: PASS
• CO: PASS
• NO2: PASS
• CH2O: PASS
• Total VOCs: PASS | Yes |
  | Electrical Safety | Compliance with UL 507:2017 Electric Fans. | PASS | Yes |
  | EMC Compatibility | Compliance with IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. | PASS | Yes |

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

The document does not specify the exact sample sizes used for the kill kinetics, air composition, electrical safety, or EMC compatibility tests. It mentions that "Non-clinical device performance testing was conducted on the subject Synexis Sphere Rx device to assess the performance and safety of the device."

The data provenance is from non-clinical device performance testing conducted by Synexis LLC and reported to the FDA. The country of origin for the data is not explicitly stated, but given that Synexis LLC is based in Lenexa, Kansas, USA, and the submission is to the U.S. FDA, it is likely that the testing was conducted in the USA. The data is prospective as it involves the testing of the Synexis Sphere Rx device itself to determine its performance characteristics.

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

This information is Not Applicable as the Synexis Sphere Rx is an air purifier, and its performance (microbial reduction, air emissions, electrical safety) is determined by laboratory testing and adherence to engineering standards, not by expert interpretation of medical images or clinical data. "Ground truth" in this context refers to the measured performance against established scientific benchmarks and regulatory standards.

4. Adjudication Method for the Test Set

This information is Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human readers or expert consensus to resolve discrepancies in interpretations, such as in image-based diagnostic studies. The tests conducted for the Synexis Sphere Rx were objective, quantitative measurements in a laboratory setting.

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

This information is Not Applicable. This device is an air purifier, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This information is Not Applicable in the context of an "algorithm only" performance, as this is a physical device, not a software algorithm for data analysis. However, the performance testing described in the document is effectively a "standalone performance" of the device itself, without human intervention aside from operating the device during the tests. The results show the intrinsic capability of the Synexis Sphere Rx to reduce airborne microbes and maintain safe emissions under specific conditions.

7. The Type of Ground Truth Used

The "ground truth" used for the performance evaluation of the Synexis Sphere Rx is based on:

• Quantitative Laboratory Measurements: For microbial reduction, the ground truth is the measured log reduction of specific organisms (K. aerogenes, S. epidermidis, MS2 bacteriophage) under controlled environmental conditions (temperature, humidity, fan speed).
• Permissible Exposure Limits (PELs) and Regulatory Standards: For air composition, the ground truth is defined by established safety limits for various gaseous species (e.g., Tox Risk Assessment, UL 867, NIOSH, EC Joint Research Report 19).
• Engineering Standards: For electrical safety and EMC compatibility, the ground truth is defined by compliance with recognized industrial standards such as UL 507:2017 and IEC 60601-1-2:2014.

8. The Sample Size for the Training Set

This information is Not Applicable. The Synexis Sphere Rx is a physical air purifier, not an AI model that requires a "training set" for machine learning.

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

This information is Not Applicable for the same reason as point 8.

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The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.

The RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions.

The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.

This device is not intended for use in areas with a sterile field or controlled air flow.

The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation.

The device uses a MERV 13 filter for particle filtration. Down upstream of the pre-filter is a PCO component. The PCO consists of a TiO2 coated mesh and UV lights. When the UV lights (UV-C) provide sufficient energy, the TiO2 coated photo catalyst is activated. This component will deactivate microorganisms and viruses through a chemical reaction.

The RGS / RGS mini model numbers RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.

The RGS / RGS mini is a medical ultraviolet air purifier intended to destroy bacteria in the air by exposure to ultraviolet radiation. The device was tested for its ability to eliminate specific bacteria and viruses.

Here's the detailed breakdown 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 the data provenance:

The document does not explicitly state the specific sample sizes (number of tests) for each microbial reduction, filtration efficiency, or shelf-life test. However, the tests against bacteria and viruses were conducted by "LMS Technologies" to assess reduction capabilities in the air of a test chamber. The origin of the data is not specified beyond being generated by "LMS Technologies," implying a laboratory setting. These tests are inherently retrospective as they are conducted on a completed device to assess its performance against predefined criteria.

Specifically, for the RGS model:

• Staphylococcus Epidermidis: Log reduction of 4.0 PFU/ft^3
• Bacteriophage MS2: Log reduction of 4.02 PFU/ft^3
• Escherichia Coli: Log reduction of 4.24 PFU/ft^3

For the RGS mini model:

• Staphylococcus Epidermidis: Log reduction of 4.04 PFU/ft^3
• Bacteriophage MS2: Log reduction of 4 PFU/ft^3
• Escherichia Coli: Log reduction of 4.0 PFU/ft^3

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The "ground truth" for the performance tests relies on the results obtained by "LMS Technologies," which are standard microbiological and engineering testing methods. Expert consensus for determining the "ground truth" for microbial reduction or filtration efficiency is typically not applicable in this context; instead, it is based on quantitative laboratory measurements compared against defined log reduction targets.

4. Adjudication method for the test set:

Not applicable. The tests involve objective quantitative measurements (e.g., log reduction, hours of operation). There is no mention of an adjudication process for these test results, as they are typically direct measurements against predetermined performance targets.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that involve human interpretation, which is not the case for an air purifier.

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

The device is an air purifier and does not involve an algorithm or human-in-the-loop performance in the conventional sense of a medical diagnostic or AI device. The performance tests are for the device's physical and functional capabilities in reducing airborne microbes and filtering particles.

7. The type of ground truth used:

The ground truth for the performance tests is derived from quantitative laboratory measurements of microbial reduction and filtration efficiency, and direct functional testing for electrical safety and shelf life. For example, for bacteria and virus reduction, the "ground truth" is the measured log reduction achieved in a controlled test chamber, compared against the acceptance criterion of a "Log 4 reduction."

8. The sample size for the training set:

Not applicable. This device is a physical air purifier, not an AI/ML-based device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

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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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The Aura Storm air purifier is a device intended for medical purposes that is used to capture and destroy bacteria and viruses in the air through the multi-stage filtration system and exposure to ultraviolet radiation.
The Aura Storm air purifier has been demonstrated to destroy the following bacteria: Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli, and virus: A/PR8/34 HIN1 virus entrained on the filter of the subject device under the following exposure conditions:
Average Maximum log reduction / entrainment time (minutes) at Fan Speed 4. Room Temperature test: Log 4 (99.99%) / 60 minutes.
Average Maximum log reduction / entrainment time (minutes) at Fan Speed 1. Room Temperature test: Log 4 (99.99%) / 120 minutes.

The Aura Storm is a multi-stage UV-C air purifier that delivers air purification for rooms up to 2700 square feet (*52ft x 52ft). The Storm inactivates and eliminates bacteria and viruses in the Aura Storm may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. The Aura Storm is a standalone device that is controlled via buttons on the top of the unit.
The Aura Storm is a dual-sided system with each side consisting of four-stage is a prefilter. The second stage is a HEPA H13+ filter. The third stage is a TiO2 cold photo-catalyst filter. Finally, the UV-C sterilization lamp emits a 253.7mm designed to activate the photo-catalyst filter and eliminate bacteria and viruses. The anion generator is used strictly to increase the size of the particulate molecules to increase the ability to capture and eliminate the bacteria and viruses. This designed system delivers a third-party tested 99.99% (4-log) sterilization in 60 minutes at the highest fan speed. The Aura storm was also tested at the lowest fan speed and delivered a 99.99% (4-log) sterilization in 120 minutes. The air flow diagram has been submitted in the 510(k) submission.
There is an internal fan which draws in air from both sides of the unit, filters it through the multi-stage system and outputs the filtered air through the top of the unit features a capacitive touch button control to operate the On/Off, fan speed (4 speeds), Auto mode, UV lamp, Anion generator, Child lock, timer, and filter reset. There is also a particulate matter sensor and color bar to indicate the level of clean air.

The Invictus Aura Storm Air Purifier (K212644) has been tested for its ability to reduce bacteria and inactivate viruses, and for its filtration efficiency.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective.

• Bacteria Reduction Test: For each of the three bacteria (Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli), three separate tests were conducted. Each test involved a control group and a test group, indicating a total of 3 samples per bacteria type, or 9 samples for bacteria reduction.
• Virus Inactivation Test: Three separate tests were conducted for the A/PR8/34 H1N1 virus.
• Filtration Efficiency Testing: The sample size for this test is not specified, but it was conducted by a 3rd party accredited laboratory.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for these tests (bacterial/viral counts, filtration efficiency) is established through laboratory measurements and standardized protocols, not by expert consensus or interpretation of images.

4. Adjudication Method

Not applicable for these types of laboratory tests. The results are quantitative measurements obtained through direct testing, rather than subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The device is an air purifier, and its performance is measured through direct laboratory tests for microbial reduction and filtration efficiency, not through human reader interpretation or clinical assessment that would require an MRMC study.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The reported performance metrics (log reduction, elimination rates, filtration efficiency) are direct measurements of the device's capability without human intervention in its operation or performance assessment.

7. Type of Ground Truth Used

The ground truth used is based on controlled laboratory measurements of:

• Bacterial colony-forming units (CFU/m3) for bacteria reduction tests.
• Viral activation/reduction measurements for virus inactivation tests.
• Particle counts for filtration efficiency tests.

These measurements are considered objective and quantitative.

8. Sample Size for the Training Set

Not applicable. The Invictus Aura Storm Air Purifier is a physical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for this device.

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The Bluezone Model RX-450 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, mold, and virus in medical facilities and occupied spaces.

The Bluezone Model Rx-450 Air Purifier has been demonstrated to entrain and destroy the following exposure/working conditions:

| Test Item | Average Net Log Reduction/Time @ High Fan
Speed. Room Temperature Test | |
|-----------|---------------------------------------------------------------------------|-------------------|
| Bacteria | Bacillus atrophaeus | 4.95 / 60 minutes |
| Bacteria | Bacillus atrophaeus | 4.00 / 48 minutes |
| Mold | Penicillium rocqueforti | 4.40 / 60 minutes |
| Mold | Penicillium rocqueforti | 4.00 / 52 minutes |
| Virus | MS-2 bacteriophage | 5.32 / 60 minutes |
| Virus | MS-2 bacteriophage | 4.00 / 40 minutes |

The Bluezone Model RX-450 is an air purification device that uses germicidal UV bulbs to inactivate viral, bacterial or fungal aerosols. The operation of the device is as follows: ambient air containing microbial aerosols is drawn into the air purifier through a prefilter and two angled aluminum honeycomb light baffles. The infective aerosols in the air are then exposed to high intensity, germicidal, ultraviolet light where the contaminants receive a UV dose of at least 10 mW*second/cm². The bacterial, fungal and viral aerosols are inactivated through the breakdown of the microbial DNA or RNA. The cleaned air is exhausted back into the room from the Bluezone Model RX-450 through an axial fan.

The provided text describes the regulatory filing for the "Bluezone Model RX-450 Air Purifier." This device is an air purifier that uses UV-C light to inactivate airborne bacteria, mold, and viruses. The document details the device's technical specifications, indications for use, and the non-clinical testing performed to establish its performance and safety.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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