(151 days)
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneby Professional Nebulizer System is suitable for use in adult and pediatric patients.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance.
I apologize, but the provided text is a 510(k) clearance letter from the FDA for the Aeroneb Professional Nebulisation System. It does not contain information about the acceptance criteria, study details, or device performance metrics as requested in your prompt.
Specifically, the document is a regulatory approval letter and does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, data provenance, or details about ground truth establishment.
- Information on expert adjudication, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request using the provided input.
§ 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).