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The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.

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The provided document is a 510(k) clearance letter from the FDA for several air purifier devices (Microcon 800M, 400M, Ex, ExC and Wall-Map Air Purifier). It states that the devices are substantially equivalent to pre-amendment devices for the indication of filtering airborne particles from air for medical purposes.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information. The letter only grants market clearance based on substantial equivalence, implying that the manufacturer would have submitted data to demonstrate this equivalence in their 510(k) submission, but that data is not part of this letter.

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The MICROCON air filtration system is used for filtering out airborne particles from air for medical purposes.

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a previously marketed device. It acknowledges the device's indications for use but does not detail any performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies that would be necessary to answer your request.

The text is a regulatory approval document and not a scientific study report.

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