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The AIRVO and myAIRVO Humidifiers are to treat patients spontaneously breathing who would benefit from receiving high flow warmed and humidified respiratory gases . This includes patients who have upper airways bypassed.

The AIRVO is for patients in hospitals. The myAIRVO is for home patients.

The AIRVO Series humidifier system is a heated humidifier with integrated flow source and a heated breathing tube. The AIRVO Series comprises two similar devices; the AIRVO which is intended for use in hospitals and myAlRVO which is intended for home use. The AIRVO Series humidifiers are intended to treat spontaneously breathing patients who would benefit from receiving high flow, warmed and humidified respiratory gases.

The AIRVO 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. The blower assembly output connects directly to a humidification chamber at the front of the device.

The second functional unit of the AIRVO 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 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 or tracheostomy interface either in the hospital or home environment.

The AIRVO device 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 does not contain information about acceptance criteria for a device, nor does it describe a study proving the device meets specific acceptance criteria based on performance data with a sample size, ground truth, or expert involvement.

The document is a 510(k) premarket notification for the AIRVO Series Humidifier. It describes:

• Device Description: The AIRVO Series humidifier system, its components, and intended use for spontaneously breathing patients needing high-flow, warmed, and humidified respiratory gases.
• Technological Characteristics Comparison: It states that the fundamental technological characteristics are equivalent to predicate devices (MR850 Humidifier and HC604 CPAP Humidifier). The key difference highlighted is the integrated flow source in the AIRVO Series, unlike the predicate MR850 which requires an external flow source.
• Non-Clinical Tests: It mentions that non-clinical testing was carried out covering mechanical, electrical, thermal safety, environmental conditions, electromagnetic compatibility, functional verification, and performance. It also states compliance with IEC 60601-1 Electrical Safety and IEC 60601-1-2 EMC. However, it does not provide details of the acceptance criteria or results of these functional performance tests. It only states that the device "meet design and performance functional requirements" and "meets the requirements of medical electrical equipment and humidifier standards for safety and performance."
• Conclusion: The device is considered substantially equivalent to predicate devices in terms of safety, effectiveness, and performance.
• FDA Communication: A letter from the FDA confirming the substantial equivalence determination for K092846.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance. The document focuses on establishing substantial equivalence for regulatory approval, primarily based on design, intended use, and compliance with general safety standards, rather than detailing a specific performance study against defined acceptance criteria.

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