(168 days)
The 56 Series Jet Nebulizer is a pneumatic nebulizer, which nebulizes specific drugs for inhalation by a patient.
The 56 Series Jet Nebulizer is a pneumatic nebulizer, which nebulizes specific drugs for inhalation by a patient.
The provided text is a 510(k) clearance letter for a medical device: the "56 Series Jet Nebulizer". This type of document is concerned with demonstrating substantial equivalence to a predicate device, not with detailing the results of a primary clinical study that establishes novel performance criteria for an AI or imaging device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance for an AI/imaging device cannot be extracted from this document.
This document primarily confirms that the device has been reviewed and found substantially equivalent to existing devices, allowing it to be marketed. It does not contain the kind of performance data or study design details that would be required to answer your specific questions, which are typically relevant for AI/imaging device submissions.
§ 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).