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Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.

Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a letter from the FDA to Far East Science & Technology Development Company, Ltd., regarding the 510(k) premarket notification for "Far-East Bouffant Caps." It states the FDA's finding of substantial equivalence for the device. The "DEVICE INDICATION FOR USE" is also provided, describing the intended purpose of the bouffant caps.

However, it does not contain any technical study details or performance data that would allow me to answer your specific questions.

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