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510(k) Data Aggregation

    K Number
    K130702
    Device Name
    AIRSONETT AIR-4
    Manufacturer
    AIRSONETT, AB
    Date Cleared
    2013-07-23

    (130 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K081062,K981841
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Airsonett AIR-4 is a Mobile Air Cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for home use only.

    Device Description

    Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.

    Air is drawn in through the air intake at the floor level and through the HEPA filter. A silent Blower (fan) brings airflow through the filter. The air is directed through the Cooler/Heater and divided into a cool respectively warm air flow. The cool air flow is directed through the Air guidance arm (neck) and out through the Airshower (Air Supply Nozzle). The Airshower can be altered in height, by adding/removing and combining the neck parts, to adapt to different types of environments. The warm air flow is directed to the Warm air outlet. On its way to the outlet the air flow passes the electronics and transports away the extra heat produced by the electronics.

    Airsonett is based on a microprocessor controlled supervisory system. This system controls the device behaviour by measuring temperatures, controlling thermoelectric modules and fan unit, monitoring user interaction as well as management of internal timers to keep track of the total ontime for the system and time since last filter change. The control functions (Front Panel Board) and power distribution function (Power Electronics Board) are allocated on two separate circuit boards.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Airsonett device, based on the provided text:

    Acceptance Criteria and Device Performance

    Study EndpointAcceptance CriteriaReported Device Performance
    Air quality in treated air envelope (clean zone)Filter Filtration efficiency ≥99.5% of particles with size Ø≥0.5µmConforms with filtration efficiency ≥99.5%.
    Air quality in treated air envelope (clean zone)Clean zone Filtration efficiency ≥99.5% of particles with size Ø≥0.5µm, which is equivalent to -Class 1000 according to FED STD 209E and -Class 6 according to ISO 14644-1 in environments of <200 000particles/ft³.Conforms with filtration efficiency ≥99.5%. ⇒ Class 1000 according to FED STD 209E and Class 6 according to ISO 14644-1 in environments of ≤200 000particles/ft³. AIR-4 is equivalent or better than previous version AIR-3, with regard to Air quality in treated air envelope (clean zone).
    Air quality in treated air envelope (clean zone)Stability of the clean zone shall be preserved. Filter efficiency shall be preserved.The stability of the clean zone is preserved and the filter does not deteriorate on efficiency over a normal working life.
    Temperature difference between supply air and ambient airTemperature difference between supply air and ambient air: ≥0.75°C (1.35 degrees F).Conforms with temperature difference between supply air and ambient air: ≥0.75°C (1.35 degrees F).

    Study Details

    1. Sample size used for the test set and the data provenance:

      • Sample Size: The document does not explicitly state a sample size for the test set. The performance tests appear to be conducted on the device itself, rather than using patient data. For example, "Efficiency test results of filter" and "Particle cleanliness of clean zone of Airsonett AIR-4."
      • Data Provenance: Not applicable as the tests are on device performance, not patient data.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • Not applicable. The ground truth for the device's technical performance is established by standardized measurement methods (e.g., laser counters for particles, temperature sensors for temperature difference) and engineering specifications, rather than expert consensus on medical images or diagnoses.

    3. Adjudication method for the test set:

      • Not applicable. The tests are objective measurements of the device's physical and mechanical performance characteristics against predefined standards, not subjective interpretations requiring adjudication.

    4. 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:

      • No MRMC study was done. This device is a "Mobile Air Cleaner" and does not involve AI or human readers for diagnostic interpretation. Its function is to physically clean air.

    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

      • A standalone performance assessment of the device (without human intervention in its function) was done, as evidenced by the "Performance Tests" section. The device's filtration efficiency and temperature control were measured directly.

    6. The type of ground truth used:

      • Objective Measurement/Engineering Standards: The ground truth for the Airsonett device's performance is based on objective measurements against established engineering and environmental control standards (e.g., particle counts, temperature differential) and filtration efficiency as defined by industry norms (e.g., FED STD 209E, ISO 14644-1).

    7. The sample size for the training set:

      • Not applicable. This device is an air cleaner, not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of these performance tests.

    8. How the ground truth for the training set was established:

      • Not applicable, as there is no training set for this type of device.
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