(121 days)
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:
| Test Item | Average Net Log Reduction / Time @ Fan Speed 6. Room Temperature Test | |
|---|---|---|
| Bacteria | Escherichia Coli | $4.20 \pm 0.11$ / 90 minutes |
| Bacteria Endospores | Bacillus Subtilis | $4.02 \pm 0.23$ / 30 minutes |
| Mold Spores | Aspergillus Brasiliensis | $4.15 \pm 0.06$ / 60 minutes |
| Virus | MS2 bacteriophage | $4.38 \pm 0.15$ / 30 minutes |
| Test Item | Single Pass Mechanical Filtration Efficiency | |
| Particulate Matter | 0.3 to 1.0 micron size particles | 95% or greater according to ASHRAE 52.2 |
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
| Test Item | Acceptance Criteria | Reported Device Performance (Average Net Log Reduction / Time @ Fan Speed 6. Room Temperature Test) |
|---|---|---|
| Bioaerosol Destruction | ||
| Bacteria (Escherichia Coli) | 4 log reduction (99.99%) | $4.20 \pm 0.11$ / 90 minutes |
| Bacteria Endospores (Bacillus Subtilis) | 4 log reduction (99.99%) | $4.02 \pm 0.23$ / 30 minutes |
| Mold Spores (Aspergillus Brasiliensis) | 4 log reduction (99.99%) | $4.15 \pm 0.06$ / 60 minutes |
| Virus (MS2 bacteriophage) | 4 log reduction (99.99%) | $4.38 \pm 0.15$ / 30 minutes |
| Particulate Matter Filtration | ||
| 0.3 to 1.0 micron size particles | 95% or greater according to ASHRAE 52.2 | Required filtration efficiency 95% or greater on 0.3 to 1.0 micron size particles was achieved. |
Performance at Different Fan Speeds (MS2 bacteriophage):
| Fan Speed | Acceptance Criteria (4 log reduction) | Reported Device Performance (Average net log reduction / time) |
|---|---|---|
| Speed 2 | 4 log reduction (99.99%) | $4.54 \pm 0.07$ / 120 mins |
| Speed 3 | 4 log reduction (99.99%) | $4.58 \pm 0.23$ / 60 mins |
| Speed 6 | 4 log reduction (99.99%) | $4.38 \pm 0.15$ / 30 mins |
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.
§ 880.6500 Medical ultraviolet air purifier.
(a)
Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.(b)
Classification. Class II (performance standards).