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The Molekule Air Pro air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria, mold, and viruses by exposure to ultraviolet radiation when operated in Auto Mode Standard or manual mode at fan speed 2 or higher.

The Molekule Air Pro air purifier has been demonstrated to entrain and destroy the following bioaerosols under the following exposure/working conditions:

The Molekule Air Pro air purifier is an ultraviolet air purifier that employs a photo electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria and viruses in air. The Molekule Air Pro may be used in medical facilities and in the home. A fan within the unit draws air up from vents in the bottom of the unit, up through the PECO filter (where it is exposed to low energy UV-A 320 - 400 nm light) and out through the vents on the top of the unit. PECO is an air purification technology that oxidizes microorganisms, including bacteria, molds and viruses. PECO works by shining UV-A light on the surface of the catalytic filter to initiate a chemical reaction that generates hydroxyl radicals. These radicals combine with microbiological contaminants that are captured on the filter. Once combined, a chemical reaction takes place destroying the contaminants.

The Molekule Air Pro is a freestanding device. It is a standalone device with an LCD display and a capacitive touchscreen user interface. Integrated WLAN provides a secondary means for controlling the device from the Molekule Android or iOS application.

Air Pro also includes a particulate matter sensor, particulate matter indicator, and Auto Protect Mode, which controls fan speed based on particulate levels detected in the use environment.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Molekule Air Pro:

1. Table of Acceptance Criteria and Reported Device Performance

Performance at Different Fan Speeds (MS2 bacteriophage):

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

The document does not explicitly state the specific sample sizes (number of units tested or number of replicates for each test) for the bioaerosol destruction and particulate filtration tests. It mentions "three PECO filters" were used for the fractional efficiency test.

The data provenance is not specified beyond being "nonclinical tests" conducted to support substantial equivalence. Information on the country of origin or whether the data was retrospective or prospective is not provided.

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

This information is not applicable and not provided in the document. The "ground truth" for these performance tests is based on objective measurements of bioaerosol reduction and particle filtration efficiency, not on expert interpretation of observational data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, which are not relevant for these specific engineering and microbiology performance tests.

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

No, an MRMC comparative effectiveness study was not done. The Molekule Air Pro is an air purification device, and its performance is evaluated through laboratory tests for bioaerosol destruction and particle filtration, not through human reader interpretation of medical images or data.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The performance testing described (bioaerosol destruction and particulate filtration) evaluated the device's capabilities without human intervention in its operation for the described tests. The device does operate in "Auto Mode Standard" or "manual mode," but the performance data presented is for the device operating independently to achieve purification.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Direct Measurement of Bioaerosol Reduction: This involves aerosolizing a known quantity of microorganisms and measuring the reduction in their concentration over time within a sealed chamber due to the device's operation.
• Standardized Filtration Efficiency Testing: This involves testing the filter's ability to remove particles of specific sizes according to the ASHRAE 52.2-2012 standard using specialized equipment.

8. Sample Size for the Training Set

This information is not applicable and not provided. The Molekule Air Pro is a physical device that performs air purification. It is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device would involve its engineering design, material selection, and optimization, not data-driven machine learning.

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

This information is not applicable and not provided, as there is no "training set" for an AI/ML algorithm in the context of this device. The development of the device's technology (PECO) and its components (filters, UV LEDs, fan) would be based on scientific principles, engineering design, and iterative testing, not on establishing ground truth for a data-driven model.

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The Molekule Air Mini air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation.

The Molekule Air Mini air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions:

Virus: MS2 bacteriophage - Average maximum log reduction / entrainment time (hours) at Fan Speed 5. Room temperature test. 5.09 ± 0.42 / 120 mins
Particulate matter: 0.3 to 1.0 micron size particles - Single Pass Mechanical Filtration Efficiency 95% or greater according to ASHRAE 52.2

The Molekule Air Mini + air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation when operated in manual mode at fan speed 3 or higher.

The Molekule Air Mini + air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions:

Virus: MS2 bacteriophage - Average maximum log reduction / entrainment time (hours) at Fan Speed 5. Room temperature test. 5.09 ± 0.42 / 120 mins
Particulate matter: 0.3 to 1.0 micron size particles - Single Pass Mechanical Filtration Efficiency 95% or greater according to ASHRAE 52.2

The Molekule Air Mini and Air Mini + air purifiers are ultraviolet air purifiers that employ a photo electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria and viruses in air. The Molekule Air Mini and Air Mini + may be used in medical facilities and in the home. The Molekule Air Mini and Air Mini + air purifiers includes a low energy ultraviolet light (UV-A 320 - 400 nm) and a catalytic filter. They are standalone devices that can be controlled via a button on the device and may also be controlled using the Molekule Android or iOS application.

PECO is an air purification technology that oxidizes bacteria and viruses. PECO works by shining UV-A light on the surface of the catalytic filter to initiate a chemical reaction that generates hydroxyl radicals. These radicals combine with microbiological contaminants, such as bacteria and viruses, that are captured on the filter. Once combined, a chemical reaction takes place destroying the contaminants.

The Molekule Air Mini and Air Mini + are freestanding devices. A fan within the unit draws air up from vents in the bottom of the unit, up through the PECO filter (where it is exposed to UV-A light), and out through the vents on the top of the unit.

The Molekule Air Mini and Air Mini + user interface includes a capacitive touch button and LED indicators on the top of the device. Power (on/off) and fan speed are controlled via the capacitive touch button. Integrated WLAN provides a secondary means for controlling the device from the Molekule Android or iOS application.

Air Mini + additionally includes a particulate matter sensor, particulate matter indicator, and Auto Protect Mode, which controls fan speed based on particulate levels detected in the use environment.

This document describes the Molekule Air Mini and Mini+ air purifiers, which are intended for medical purposes to capture particulate matter and destroy bacteria and viruses. The following information is extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Virus (MS2 bacteriophage) testing: Performed using a sealed environmental bioaerosol chamber containing the Molekule® Air Mini device. The sample size for the MS2 bacteriophage destruction efficacy testing is not explicitly stated as a number of devices or iterations in the provided text, beyond the mention of "aerosolized into a sealed environmental bioaerosol chamber containing Molekule® Air Mini device."
• Particulate Matter Filtration: Tested using "three PECO filters."
• Data Provenance: The document does not specify the country of origin of the data. The tests described are "Performance Testing" which are laboratory-based, non-clinical tests. They are retrospective in the sense that they were conducted for the purpose of the 510(k) submission, confirming the device's performance after its design.

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

Not applicable. The ground truth for the performance tests (virus destruction and particulate filtration) was established by direct measurement using scientific methods and established standards (ASHRAE 52.2), not by expert consensus in an observational or diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. The reported results are direct measurements from performance tests, not subjective assessments requiring adjudication.

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

No. The document explicitly states: "No clinical tests were required to demonstrate substantial equivalence." This means there was no human-in-the-loop study, and therefore no MRMC study to assess human reader improvement with or without AI assistance. The device is an air purifier, not an AI diagnostic tool that human readers would use in conjunction with.

6. Standalone Performance

Yes, a standalone performance study was done. The document details "Performance Testing" for both virus destruction and particulate matter capture, which evaluates the device's capabilities without human intervention or interpretation. The results in the table directly reflect the algorithm's (or device's) standalone performance against the specified criteria.

7. Type of Ground Truth Used

The ground truth used for these performance studies was:

• Quantitative Measurement/Laboratory Testing: For virus destruction, it was the measured "log reduction" of MS2 bacteriophage in a sealed chamber. For particulate matter capture, it was the "Single Pass Mechanical Filtration Efficiency" measured according to ASHRAE 52.2. These are direct, objective measurements of the device's physical performance.

8. Sample Size for the Training Set

Not applicable. The Molekule Air Mini and Air Mini+ are physical medical devices (air purifiers) that use a photo electrochemical oxidation (PECO) ultraviolet air purification technology. They do not appear to employ a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML models. The "software" mentioned is for basic device control (on/off, fan speed) and authentication of filters, not for complex data processing requiring a training set.

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

Not applicable, as there is no mention of an AI/ML training set in the provided document.

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The Molekule Air Pro RX air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation.

The core technology components of the Molekule Air Pro RX air purifier have been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure conditions:

| Organism | Name | Average Maximum log reduction
/exposure time (hours) |
|----------|-------------------|---------------------------------------------------------|
| | | Room temperature test |
| Virus | MS2 bacteriophage | 5.21 / 24 hours |

The Molekule Air Pro RX air purifier employs a photo-electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria, viruses and mold in air in medical facilities. The Molekule Air Pro RX air purifier includes a pre-filter and low energy ultraviolet lights (UV-A 320-400 nm), and a catalytic filter.

Here's a summary of the acceptance criteria and study information for the Molekule Air Pro RX, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not explicitly stated for specific tests, but the performance data presented is for MS2 bacteriophage. The context implies the tests were conducted for the purpose of this 510(k) submission (prospective in that sense) and likely within the US, given the FDA submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the performance test (log reduction of MS2 bacteriophage) is based on laboratory measurements of destruction, not expert interpretation.

3. Adjudication method for the test set: Not applicable. This is a performance test involving direct measurement, not assessment by experts requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a device that directly destroys microorganisms; human reader performance is not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes. The performance tests described (e.g., MS2 bacteriophage log reduction) evaluate the device's efficacy in destroying bacteria and viruses independently, without human interaction influencing the destruction process.

6. The type of ground truth used: For the performance test, the ground truth is laboratory measurement of microorganism destruction, specifically the calculated log reduction of MS2 bacteriophage.

7. The sample size for the training set: Not applicable. This is a hardware device undergoing performance testing, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for a machine learning algorithm.

Summary of Non-Clinical Tests Provided:

The 510(k) submission included several non-clinical tests to support substantial equivalence:

• Risk Analysis
• Software verification and validation testing
• Electrical safety testing per UL 507:2017
• Electromagnetic compatibility (EMC) testing per IEC 60601-1-2: 2014
• Performance tests for UV light leakage and light intensity
• Fluid modeling to confirm no impact on laminar flow systems
• Testing to demonstrate filtration performance and destruction of bacteria
• Third-party testing to characterize the kill rate kinetics for MS2 bacteriophage deposited on the catalytic filter media when exposed to the UV-A light. This test showed an average of 3.41 LOG reduction after one hour and 5.21 LOG reduction after 24 hours of UV exposure at room temperature.

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