(224 days)
The CUBE 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 CUBE Air Purifier has been demonstrated to destroy the following MS2 bacteriophage, Staphylococus epidermidis, Escherichia coli entrained on the filter of the under the following exposure conditions:
| Organisms | Name | Average Maximum log reduction/
exposure time (hours) | |
|-----------|----------------------------|---------------------------------------------------------|--|
| | | Room temperature test | |
| Virus | MS2 bacteriophage | 5.33±0.23 /60 mins | |
| Virus | Phi-X174 bacteriophage | 5.34±0.11 /60 mins | |
| Bacteria | Staphylococcus epidermidis | 5.36±0.28 /60 mins | |
| Bacteria | Escherichia coli | 5.17±0.05 /60 mins | |
The CUBE Air Purifier employs a photocatalytic oxidation (PCO) ultraviolet air purification technology that destroys bacteria and viruses in air in medical facilities. The CUBE Air Purifier includes a pre-filter, a dust collecting filter, UV-A LED lights (320-400 nm), and a catalytic filter.
The device is intended to be placed in medical and healthcare facilities.
The provided text describes the acceptance criteria and the study that proves the CUBE Air Purifier meets those criteria. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Performance study for removal efficiency by particle size using dust collecting filter materials | To ensure the CUBE Air Purifier meets filtration efficiency Requirements (95 % or greater on 0.3 to 1.0 micron size particles) | The filter material shall achieve 95 % or greater on 0.3 to 1.0 micron size particles according to ASHRAE 52.2. | Required filtration efficiency 95 % or greater on 0.3 to 1.0 micron size particles was achieved |
| The estimate of the catalytic filter lifetime based on performance and stability evaluation | To ensure the sustainability of photocatalytic activity and durability of the catalytic filter after 10 years of operation under constant UVA irradiation. | The photocatalytic activity (CADR against toxic gas) shall maintain more than 50 % of initial activity after accelerating test simulating 10 years of operation. | Photocatalytic activity (CADR against toxic gas) after accelerating test was above 50 % compared to initial activity. |
| Performance evaluation for the estimate of UVA LED Lifetime based on acceleration test | To estimate the usable lifetime of UVA LED lamp | L50/B50 | 111,638 hours (12.7 years) to reach L50/B50. |
| Efficacy against MS2 bacteriophage, Phi-X174 bacteriophage, Staphylococcus epidermidis, Escherichia coli (initial) | To evaluate the efficacy of the CUBE Air Purifier at reducing viability of aerosolized MS2 bacteriophage, Phi-X174 bacteriophage, Staphylococcus epidermidis, Escherichia coli by a combination (of PCO and UV-A) | 4 log reduction (99.99 %) | MS2 bacteriophage: 5.33 ± 0.23 / 60 mins |
| Phi-X174 bacteriophage: 5.34 ± 0.11 / 60 mins | |||
| Staphylococcus epidermidis: 5.36 ± 0.28 / 60 mins | |||
| Escherichia coli: 5.17 ± 0.05 / 60 mins | |||
| Efficacy of the CUBE Air Purifier Device against MS2 Bacteriophage After 10 Years of Simulated Use | To evaluate the efficacy of the CUBE Air Purifier after 10 years of simulated use at reducing viability of aerosolized MS2 bacteriophage. | 4 log reduction (99.99 %) | MS2 Bacteriophage: 5.35 ± 0.26 / 60 mins |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing conducted in a controlled laboratory environment. The "sample size" here refers to the number of tests performed on the device itself, rather than human subjects or a dataset of medical images.
- Sample Size for performance testing: The document does not explicitly state the number of repetitions for each performance test (e.g., how many times the aerosolized bacteria/virus reduction was measured). It typically presents average results with standard deviations, implying multiple runs were conducted.
- Data Provenance: The studies were conducted as part of the device's premarket notification (510(k)) submission to the FDA. This indicates that the data was generated specifically for regulatory purposes in a controlled laboratory setting (e.g., environmental bioaerosol chamber). The country of origin for the studies is not explicitly stated, but the submitter (Samsung Electronics Co., Ltd.) is based in South Korea. The studies are prospective in nature, as they involve actively testing the device's performance under specified conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) to this type of device (air purifier). The "ground truth" for air purifiers is established through direct laboratory measurements of microbial reduction and filter efficiency, not through human expert interpretation of data like in medical imaging.
4. Adjudication Method for the Test Set
This is not applicable (N/A). Adjudication methods (e.g., 2+1, 3+1 consensus) are typically used in studies involving human interpretation (like in diagnostic imaging studies) to resolve disagreements among readers. For an air purifier, the "ground truth" is determined by objective scientific measurements in a lab.
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 is not applicable (N/A). MRMC studies are relevant for diagnostic devices where human readers (e.g., radiologists) interpret cases (e.g., medical images), often with or without AI assistance. This document describes the performance of an air purifier in reducing airborne pathogens, not a diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the context of an air purifier. The "device performance" is the standalone performance. The machine itself is performing the intended function (destroying bacteria and viruses). There isn't an "algorithm only" that then needs to be compared to a human-in-the-loop performance, as the device's function is purely mechanical and chemical (UV-A and photocatalytic oxidation). The tests performed (e.g., log reduction of microbes in a chamber) are measures of its standalone efficacy.
7. The Type of Ground Truth Used
The ground truth used in these studies is based on direct laboratory measurements of microbial viability and particle count reduction.
- For microbial reduction: The ground truth is the measured decrease in the concentration of specific bacteria and viruses (MS2 bacteriophage, Phi-X174 bacteriophage, Staphylococcus epidermidis, Escherichia coli) in a sealed chamber after exposure to the CUBE Air Purifier. This is a quantitative outcome data obtained through standard microbiological assay techniques.
- For filter efficiency: The ground truth is the measured percentage of particles (0.3 to 1.0 micron size) removed by the filter, according to ASHRAE 52.2 standards, which is a performance standard/outcome data.
8. The Sample Size for the Training Set
This is not applicable (N/A). The CUBE Air Purifier is a physical device employing UV and photocatalytic oxidation for air purification. It is not an AI/ML-based device that requires a "training set" of data to learn or develop an algorithm. Its performance is based on established physical and chemical principles.
9. How the Ground Truth for the Training Set Was Established
This is not applicable (N/A), as there is no "training set" described for this device.
§ 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).