(155 days)
The 56 series Aerosol Generator is for the production of compressed air to operate a nebulizer for the production of medical aerosol for respiratory disorders. The 56 series Aerosol Generator requires a nebulizer and medication for operation. The use of the 56 series Aerosol Generator is for the sole purpose of compressed air production and requires the order of a physician for medical use.
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The provided text is a 510(k) clearance letter from the FDA for a device called "56 Series Compressor" (referred to as "56 series Aerosol Generator" in the Intended Use section). This document does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing its commercialization. It discusses general regulatory provisions and contact information for further inquiries.
Therefore, I cannot provide the requested information from the given text. The text does not describe a study, sample sizes, expert qualifications, ground truth, or any performance metrics.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).