(62 days)
For Transporting and Isolating a TB patient or a suspected TB patient
Not Found
The provided text is a 510(k) summary for a medical device (Failsafe Isolation Systems Transport Model 07 and Portable Isolation Model 77). It is a letter from the FDA confirming substantial equivalence to a predicate device. This type of document does not contain details about specific acceptance criteria, study designs, sample sizes, or ground truth establishment for the device itself.
It focuses on regulatory approval based on equivalence to existing devices, not performance criteria from a clinical trial or algorithm validation study. Therefore, I cannot extract the requested information from the provided text.
To answer your questions, I would need a different type of document, such as a clinical study report, a device validation report, or a detailed technical submission describing the performance evaluation.
§ 880.5450 Patient care reverse isolation chamber.
(a)
Identification. A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.(b)
Classification. Class II (performance standards).