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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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Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.

Far-East Shoe Covers are disposable and single used devices, intended for medical purposes, that are worn on to cover the shoes of all personnel during the general medical procedures, or surgical procedures to protect the medical personnel, or surgical personnel from transfer of bacteria, micro-organisms and particulate material.

The provided text is a 510(k) premarket notification letter from the FDA regarding a device called "Far-East Shoe Covers." It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market, but it does not detail any performance studies conducted by the manufacturer.

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Isolation for Far-East Barrier Gowns

Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.

Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.

This document is an FDA 510(k) clearance letter for "Far-East Isolation Gowns." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI-powered medical device.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

Substantial equivalence is based on comparing the new device to a predicate device, not on specific performance criteria demonstrated through a clinical study as would be expected for an AI device.

Therefore, I cannot provide the requested information. The document pertains to general medical gowns, not an AI device, and the clearance is based on substantial equivalence, not a performance study.

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