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The Bluezone Model RX-450 Air Purifier is a free standing, air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria, mold, and virus in medical facilities and occupied spaces.

The Bluezone Model Rx-450 Air Purifier has been demonstrated to entrain and destroy the following exposure/working conditions:

The Bluezone Model RX-450 is an air purification device that uses germicidal UV bulbs to inactivate viral, bacterial or fungal aerosols. The operation of the device is as follows: ambient air containing microbial aerosols is drawn into the air purifier through a prefilter and two angled aluminum honeycomb light baffles. The infective aerosols in the air are then exposed to high intensity, germicidal, ultraviolet light where the contaminants receive a UV dose of at least 10 mW*second/cm². The bacterial, fungal and viral aerosols are inactivated through the breakdown of the microbial DNA or RNA. The cleaned air is exhausted back into the room from the Bluezone Model RX-450 through an axial fan.

The provided text describes the regulatory filing for the "Bluezone Model RX-450 Air Purifier." This device is an air purifier that uses UV-C light to inactivate airborne bacteria, mold, and viruses. The document details the device's technical specifications, indications for use, and the non-clinical testing performed to establish its performance and safety.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Additionally, the "Indications for Use" section (pages 2 and 4) provides specific performance targets for different microorganisms, which can also be considered acceptance criteria.

Note: 99.99% reduction is equivalent to a 4.0 log reduction.

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

The document describes non-clinical laboratory testing rather than human subject or image-based studies. Therefore, typical "sample sizes" for test sets in the context of AI/machine learning or human reader studies are not applicable directly.

• Sample Size: The data for the efficacy tests (microorganism removal) are based on controlled laboratory experiments using specific volumes (e.g., 16m³ chamber for MS2, 735 cubic foot chamber for bacterial/mold spores). The precise number of replicate tests or experimental runs is not specified in this summary document.
• Data Provenance: The tests are described as non-clinical testing, implying lab-based experiments. No information is provided regarding the country of origin of the data collectors/labs, nor is it specified if the data is retrospective or prospective, as these terms typically apply to clinical studies. Given it's a device efficacy test, it would inherently be prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: This filing describes physical device performance testing (e.g., electrical safety, UV irradiance, germicidal efficacy against lab-cultured microorganisms), not AI/machine learning performance requiring human expert ground truth labeling. Therefore, there is no mention of experts establishing ground truth in this context.

4. Adjudication Method for the Test Set

• Not Applicable: As this is non-clinical device performance testing, adjudication methods typically used for human expert review in diagnostic studies are not relevant. The results are obtained from direct measurements and observations in a laboratory setting.

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

• Not Applicable: The document explicitly states "Summary of Clinical Testing: Not applicable." This is a premarket notification (510(k)) for an air purification device, and its safety and efficacy were demonstrated through non-clinical laboratory tests, not comparative human clinical trials or diagnostic performance studies involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Not Applicable: This is a physical device (air purifier), not a software algorithm or AI. Its performance is inherent to its design and function.

7. Type of Ground Truth Used

The ground truth for this device's performance is established through laboratory measurements and direct observation of microbial inactivation.

• Microorganism Inactivation: The ground truth for efficacy (e.g., log reduction of bacteria, mold, virus) is determined by standard microbiological testing methods, likely involving quantifying viable microorganisms before and after exposure to the device in a controlled chamber. This is analogous to outcomes data in a very specific, controlled laboratory environment.
• Safety Parameters: Ground truth for electrical safety, ozone emission, and UV leakage are based on adherence to recognized safety standards (e.g., UL, IEC) through direct measurement by specialized equipment.

8. Sample Size for the Training Set

• Not Applicable: This is a physical device, and the concept of a "training set" (used for machine learning models) does not apply here. The device's design and operating parameters are not "trained" on data in the same way an algorithm would be. Its performance is a result of its engineering.

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

• Not Applicable: As there is no "training set" for a physical device, the method of establishing ground truth for it is not relevant. The device is built based on established principles of UV-C germicidal action, and its performance is
  verified through empirical testing as detailed above.

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