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This product is intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use.

The AeroChamber2go* Anti-Static Valved Holding Chamber (VHC) is a portable holding chamber intended to be used by patients (5+ years) who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. It is a single patient, multiple use device intended for home use. This device is not used with a specific druq nor is it distributed with such drugs.

The provided text is a 510(k) summary for a medical device (AeroChamber2go Anti-Static Valved Holding Chamber). It describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

It does NOT describe a study that proves the device meets the acceptance criteria of an AI/ML model for an image analysis task.

Therefore, I cannot fulfill your request for information related to AI/ML model performance, ground truth, expert adjudication, or MRMC studies based on this document. The document pertains to the physical and chemical properties of a medical device, not a software-driven diagnostic or image analysis tool.

The "acceptance criteria" discussed in this document refer to the device's mechanical, material, and aerosol delivery performance characteristics, not the performance of an AI system.

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