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AirKEE T900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacterial, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.

AirKEE T900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions:

AirKEE T900 is a mobile medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE T900 is controlled via a touchscreen control panel on the machine.

AirKEE T900's main components consist of:
Multi-stage air treatment

• a filtration system with primary filter, medium efficiency filter, HEPA filter, activated O carbon filter, and nano-material filter
• UV lamps that generate UV-C irradiation to eliminate microorganisms о
• o a motor/impeller to move air through the filtration system

System control

• o an electronic control system to power and control the device
• a touch panel interface to indicate the working status of the device and consumables O

AirKEE T900's multi-stage air treatment: Air enters through the bottommost chamber and passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through modified activated carbon and patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Lastly, HEPA H14 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top of the machine.

The touch panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.

The provided FDA 510(k) notification describes the AirKEE T900, a medical ultraviolet air purifier, and its performance. It outlines the device's indications for use and presents a summary of non-clinical tests to demonstrate its effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The term "acceptance criteria" is derived directly from the "Acceptance Criteria" column in the provided table.

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

The document does not specify the sample size for the test set in terms of the number of individual devices tested or the number of replicates for each microbiological test. The provenance of the data is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, beyond "Internal Standards" for microorganism performance. These are non-clinical laboratory tests.

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

This document describes non-clinical performance testing of a physical device (air purifier) for its ability to filter and destroy microorganisms and to meet safety standards. It does not involve interpretation of medical images or diagnostic outputs that would typically require human experts to establish "ground truth" in the context of an AI/human reader study. Therefore, the concepts of "number of experts" and "qualifications of those experts" are not applicable to the studies described.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments, typically in diagnostic or imaging contexts. Since the described studies are non-clinical laboratory performance tests (e.g., measuring log reduction of microorganisms, filter efficiency, electrical safety), adjudication methods are not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic devices where the AI's impact on human reader performance is evaluated. The AirKEE T900 is an air purification device, and its performance is assessed through laboratory-based efficacy and safety tests, not through human reader interpretation of data or images.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the studies described are essentially "standalone" performance evaluations of the device itself, without human-in-the-loop interaction in the context of a diagnostic or interpretive task. The performance metrics (e.g., log reduction of microorganisms, filter efficiency, ozone levels) are direct measurements of the device's function.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations is established through:

• Quantitative Microbiological Assays: For microorganism performance, the "ground truth" is the measured reduction in viable microorganisms (bacteria, mold, viruses) under specific test conditions. This is an objective, laboratory-derived measurement.
• Physical Measurements and Engineering Standards: For fractional efficiency, electrical safety, and ozone release, the "ground truth" is defined by adherence to established industry standards (IEST-RP-CC001.6, UL 507, IEC 60601-1-2, UL 867) and direct physical measurements confirming compliance.

8. The Sample Size for the Training Set

This document details non-clinical performance and safety testing of a manufactured device, not a machine learning or artificial intelligence (AI) algorithm. Therefore, the concept of a "training set sample size" is not applicable, as there is no AI model being trained.

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

As noted above, this pertains to a physical medical device, not an AI model. Therefore, the concept of a "training set" and "established ground truth for the training set" is not relevant to this submission. The device's performance is based on its physical and functional design, which is validated through the non-clinical tests described.

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AirKEE P900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacteria, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.

AirKEE P900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions:

AirKEE P900 is a mobile multi-function medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE P900 is controlled via a touchscreen control panel on the machine.

AirKEE P900's main components consist of:

Multi-stage air treatment

• a filtration system with primary filter, HEPA filter, activated carbon filter, and nano- O material filter
• UV lamps that generate UV-C irradiation to inactivate and eliminate microorganisms o
• a motor/impeller to move air through the filtration system o

System control

• o a touch panel interface to indicate the working status of the device and consumables
  AirKEE P900's multi-stage air treatment: Air enters through the bottommost chamber and fans direct the air in an upwards manner. Firstly, air passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Air then passes through activated carbon filter. Lastly, HEPA H13 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top in an upwards manner.

The control panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.

The AirKEE P900 is a medical ultraviolet air purifier that was tested to demonstrate its effectiveness in capturing and destroying bacteria, mold, and viruses in the air.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample size for each microorganism performance test (e.g., how many runs were performed for each microorganism). However, it does specify that the tests were conducted "in a 20m³ chamber" and "entrained on the filter of the subject device."

The data provenance is not explicitly mentioned as a country of origin. The submitter is "HealKee Medical Pte Ltd" from Singapore, suggesting the testing might have been conducted in Singapore or a location associated with the company's operations. The data appears to be prospective, as it describes tests conducted specifically for the AirKEE P900 device to demonstrate its performance against predefined criteria.

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 performance evaluation for microorganism reduction and other non-clinical tests likely relied on established laboratory protocols and standards, rather than expert consensus on individual "cases" in the typical sense of diagnostic imaging. For a medical UV air purifier, the "ground truth" would be the measurable reduction of microorganisms.

4. Adjudication Method for the Test Set:

This information is not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretations (e.g., radiologists reviewing images) to establish a consensus ground truth. For a device like an air purifier, performance is measured quantitatively through laboratory tests.

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

An MRMC study was not done. This type of study assesses the performance of human readers, with and without AI assistance, which is not relevant for an air purifier.

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

For the microorganism performance, the study can be considered a standalone performance study of the device (AirKEE P900) operating independently. The device's ability to destroy microorganisms is measured directly in a controlled environment without human intervention during the process itself (though humans operate and set up the device and tests).

7. Type of Ground Truth Used:

The ground truth used for the microorganism performance is quantitative laboratory measurement (direct bacterial/viral/mold count reduction). This involves culturing and counting microorganisms before and after exposure to the device in a controlled chamber, and computing the log reduction.

For fractional efficiency, electrical safety, EMC, and ozone, the ground truth is established by conformance to recognized standards (IEST-RP-CC001.6, UL 507, IEC 60601-1-2, UL 867).

8. Sample Size for the Training Set:

This information is not applicable. The AirKEE P900 is an electromechanical device with filtration and UV-C technology, not an AI/ML-driven diagnostic or analytical tool that requires a "training set" of data in the typical sense for algorithm development. Its performance is based on its physical design and operation, which are then tested for efficacy.

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

This information is not applicable, as there is no "training set" for this type of device. The device's design principles and expected performance are based on established scientific principles of filtration, UV-C radiation, and photocatalysis. The validation occurred through the non-clinical tests described.

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