(190 days)
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
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Virus Destruction (MS2 bacteriophage) | 4 log reduction (99.99%) | 4.18 ± 0.56 net log reduction at 90 mins |
| 5.09 ± 0.42 net log reduction at 120 mins | ||
| Particulate Matter Capture (0.3 to 1.0 micron size particles) | 95% or greater according to ASHRAE 52.2 | Required filtration efficiency 95% or greater was achieved. |
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.
§ 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).