Search Results

The spirometer (Air Smart Extra) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a spirometer. It confirms the device's substantial equivalence but does not contain any information about acceptance criteria, device performance metrics, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies (MRMC) or standalone algorithm performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

Ask a specific question about this device

The device is a Vibrating Mesh Nebulizer System that designed to aerosolize liquid medication for inhalation therapy by the patient. It is not intended for use with Pentamidine.

Vibrating Mesh Nebulizer System

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study proving a device meets acceptance criteria.

The document is an FDA 510(k) clearance letter for a "Portable Mesh Nebulizer" and primarily focuses on:

• The FDA's review and determination of substantial equivalence.
• Regulatory requirements for the device.
• Instructions for use, patient population, and environment of use for the device.

Therefore, I cannot fulfill your request based on the given input.

Ask a specific question about this device