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EOS Air Cleaner is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation in general medical environment.

The core technology components of the EOS Air Cleaner have been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter to achieve an average 4 log reduction over 4 hours in a 30 cubic meter chamber.

EOS Air Cleaner employs an ultraviolet air purification technology that destroys bacteria and viruses in air in hospital, nursing homes, medical facilities, but not in specialized medical place such as operating rooms.

EOS Air Cleaner is a free-standing device, which has a well-sealed metal box including a fine filter, motor, two UV-C lamps, and a HEPA filter. By sucking surrounding air into the device, EOS Air cleaner can suction the air into the device and filtering the air by fine filter with UV-C light radiation, then the purified air is expelled from the cabinet.

The bacteriophage deposited onto the surface of EOA Air Cleaner's proprietary photocatalytic coated filter media will be killed after exposure to EOS Air Cleaner's UV-C light

UV-C light in 255 nm which is commonly called germicidal kills any remaining bacteria and viruses, as the radiation penetrates the cell walls of bacteria and is absorbed by the organic structures within the bacterial and virus, causing them to decompose and the cell to die.

Here's the breakdown of the acceptance criteria and study information for the EOS Air Cleaner, based on the provided document:

Acceptance Criteria and Device Performance

Note regarding the Bacteriophage Test's Reported Performance: The "Indications for Use" section and the "Comparison of Technological Characteristics" table provide more specific performance details:

• The core technology components have been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter to achieve an average 4 log reduction over 4 hours in a 30 cubic meter chamber.
• Specific log reductions at different speeds (Speed 1: 4.05 / 4 hours, Speed 5: 4.22 / 4 hours, Speed 10: 4.45 / 4 hours) are also reported.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not explicitly state the sample size for the bacteriophage tests (e.g., number of test runs or replicates).
   • The data provenance is from non-clinical testing, likely conducted in a laboratory setting, and the manufacturer is Guangzhou Ajax Medical Equipment Co., Ltd. in China. The document does not specify if the data is retrospective or prospective, but it implies prospective testing for regulatory submission.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • The document does not mention individual experts or their qualifications for establishing ground truth for the non-clinical tests. These types of tests typically rely on standardized laboratory protocols and measurements rather than expert consensus on individual "cases."

3. Adjudication Method for the Test Set:

   • Not applicable as this involves non-clinical laboratory testing against pre-defined performance metrics, not human expert interpretation requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. The device is an air cleaner, and its performance is measured mechanically and biologically, not through human reader interpretation of medical images or data.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, the provided studies are standalone evaluations. The "Bacteriophage Test," "Aging Test," and "Software Validation" all evaluate the device's inherent performance and functionality without human interaction beyond operating and monitoring the device.

6. Type of Ground Truth Used:

   • For the Bacteriophage Test and Aging Test: Direct measurement of viral load reduction (specifically MS2 bacteriophage bioaerosol) in a controlled environment. This is a scientific and empirical ground truth.
   • For IEC 60601-1/60601-1-2 and Software Validation: Adherence to established international standards and design criteria.

7. Sample Size for the Training Set:

   • The document does not mention a training set or machine learning component for the EOS Air Cleaner. The device's function relies on physical processes (UV radiation, filtration) rather than an AI/ML algorithm that requires training data.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no mention of a training set or AI/ML algorithm.

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