Search Results

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.

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device