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The Airworks™ Nebulizer pel 200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer. Airworks™ Nebulizer pe1200m is intended for use at home or a medical facility, such as a hospital or doctor's office.

The Airworks™ Nebulizer pe1200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

The Airworks™ Nebulizer pe1200m uses a vibrating mesh technology, which is comprised of a medicalgrade stainless steel disk containing 1,000 precision-formed holes. When energy is applied, the disk vibrates approximately 110,000 times per second. This rapid vibration causes a difference in pressure on either side of each aperture, drawing liquid through the holes to form consistently sized droplets.

The Airworks™ Nebulizer pe1200m is lightweight, compact and virtually silent. A rechargeable lithiumion battery powers the device.

The device described Airworks™ Nebulizer pe1200m is not an AI/ML device.

This device is a nebulizer which is a medical device that converts liquid medicine into a mist that can be easily inhaled into the lungs. The provided document is a 510(k) summary for its clearance. The summary focuses on comparing its physical characteristics and aerosol performance with a predicate device. There is no mention of AI/ML components or functionalities.

Therefore, the requested information regarding acceptance criteria and study for an AI/ML device cannot be extracted from this document.

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