(149 days)
The CerroZone Mobile is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.
The CerroZone Mobile is a medical recirculating air cleaner that uses multiple inactivation processes consisting of reactive oxidizing species (ozone) and ultraviolet radiation to inactivate bacteria and viruses in the air. The CerroZone Mobile may be used in medical facilities. Once turned on, inlet air is passed through CerroZone Mobile's inline flow-through design which inactivates bacteria and viruses in a single pass flow-through. The device generates 220 cubic feet of air per minute (CFM), or 2.36 air changes per hour (ACH) in a standard 5,600 cu. Ft room. This process of air being inlet, purified, then outlet, lasts approximately 1.2 seconds. A 4 LOG reduction of airborne particles in a standard 579 cu. Ft room is achieved in 30 minutes or less. A 5.67 LOG, or 99.9998%, reduction is achieved in 45 minutes or less.
The CerroZone Mobile device is a medical recirculating air cleaner designed to filter out and inactivate airborne bacteria and viruses. The following information summarizes its acceptance criteria and the studies conducted.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| MS2 bacteriophage aerosolization in a sealed environmental bioaerosol chamber | To evaluate the efficacy of the CerroZone Mobile at reducing viability of aerosolized MS2 bacteriophage by a combination of entrainment and destruction | Greater than 4 log reduction (99.99%) | Average net log reduction for MS2 bacteriophage: 5.67 ± 0.19 / 60 minutes |
| Methicillin Resistant Staphylococcus epidermidis (MRSE) aerosolization in a single-pass flow-through chamber connected to the CerroZone Mobile | To evaluate the efficacy of the CerroZone Mobile at reducing viability of aerosolized bacteria by a combination of entrainment and destruction | Greater than 3 log reduction (99.9%) in single-pass testing | Demonstrated effectiveness against Staphylococcus epidermidis |
| Ozone Emissions | To assess ozone emissions | Emissions within the maximum acceptable level of ozone given in 21 CFR 801.415 (0.050 ppm) | Emits between 0.000 and 0.010 ppm of Ozone with a measured absolute max of 0.036 ppm. All emissions fall within the acceptable level. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the biological aerosolization tests (MS2 bacteriophage and MRSE). The studies appear to be laboratory-based non-clinical tests rather than human subject or field trials, so terms like "country of origin" and "retrospective/prospective" might not be strictly applicable in the same way they would be for clinical studies. The context implies these were controlled experiments conducted to assess device performance under specific conditions.
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 "ground truth" for these non-clinical tests would have been established by the direct measurement of reduction in viable microorganisms using standard microbiological techniques, rather than expert interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The tests involved direct measurement of microbial reduction, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The CerroZone Mobile is a medical device for air cleaning, not an interpretative diagnostic tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
These were standalone performance tests of the device itself (algorithm not applicable), evaluating its ability to reduce airborne pathogens directly.
7. The Type of Ground Truth Used:
The ground truth used for the efficacy studies was based on quantitative laboratory measurements of microbial viability (e.g., plaque assays for bacteriophages, colony counts for bacteria) before and after exposure to the device. For ozone emissions, the ground truth was direct quantitative measurement of ozone concentration.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical air cleaner, 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 type of device.
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).