(122 days)
The ultrasonic mesh nebulizer model NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital & sub-acute care setting.
The ultrasonic mesh nebulizer model NM211A is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient.
The provided text is a 510(k) summary for a medical device (Ultrasonic Mesh Nebulizer Model NM211A), which primarily focuses on regulatory clearance based on substantial equivalence to a predicate device. It states the indications for use but does not contain information about specific acceptance criteria or a study proving the device meets those criteria, especially in the context of AI/ML performance.
Therefore, I cannot provide the requested information from the given document. The document describes a traditional device clearance, not one for an AI/ML-driven medical product that would typically involve acceptance criteria related to algorithm performance, training/test sets, ground truth establishment, or clinical effectiveness studies as described in your prompt.
§ 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).