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The AIRVO and myAIRVO humidifiers are for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 5 - 50 L/min depending on the patient interface.

The AIRVO is for patients in hospitals and long-term care facilities. The myAIRVO is for patients in homes and long-term care facilities.

The AIRVO Series Humidifier system is a heated humidifier with integrated flow source and a heated breathing tube to deliver conditioned respiratory gas flow to a patient. The AIRVO Series comprises two similar devices; the AIRVO which is intended for use in hospitals and long term care facilities and myAIRVO which is intended for home use and long term care facilities.

The AIRVO Series Humidifier is comprised of two connected functional units. One is a motorised fan assembly that provides air flow. The fan speed is directly related to delivered flow, and is controlled by software with a flow sensor. The blower assembly output connects directly to a humidification chamber at the front of the device.

The second functional unit of the AIRVO Series Humidifier is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects directly to the blower assembly via a port at the back of the chamber. Software monitors ambient temperature and flow to optimise humidity delivery to the patient and minimise condensation.

The device interfaces with the patient via either a nasal cannula, tracheostomy interface, or face mask.

The AIRVO Series Humidifier is reusable and by using the high level disinfection kit it can be used on multiple patients. The interfaces, tubes and water chambers are disposable and are for single patient use only. The device may be operated by nurses, respiratory therapists, doctors or patients.

The provided text is a 510(k) summary for the AIRVO Series Humidifier, which describes its features, intended use, and comparison to predicate devices, along with the FDA's clearance letter. However, it does not contain the kind of detailed clinical study information (acceptance criteria, specific performance metrics with numbers, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that you're asking for.

The document focuses on non-clinical performance data, primarily stating that the device meets mechanical, electrical, thermal safety, environmental conditions, electromagnetic compatibility, functional verification, and performance requirements by adhering to standards like ISO 8185, IEC 60601-1, and IEC 60601-1-2.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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