(219 days)
The HEPA-CARE/Air filtration systems are used for filtering out airborne particles from the air for medical purposes.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "HEPA-CARE Air Cleaner." It is not a study report or a technical document detailing acceptance criteria and performance data. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text.
The document primarily focuses on:
- Confirming the FDA's review and determination of substantial equivalence for the device.
- Stating the regulatory class of the device.
- Outlining the general controls and regulations the device is subject to.
- Providing contact information for regulatory inquiries.
- Stating the intended use of the device, which is "for filtering out airborne particles from the air for medical purposes."
In summary, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria and performance study details.
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).