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THE SURGICAL FACE MASK IS INTENDED TO BE WORN BY OPERATING ROOM PERSONNEL DURING SURGICAL PROCEDURES TO PROTECT BOTH THE SURGICAL PATIENT AND THE OPERATING ROOM PERSONNEL FROM TRANSFER OF MICRO-ORGANISMS, BODY FLUIDS AND PARTICULATE MATERIAL.

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The provided document is a 510(k) clearance letter from the FDA for a surgical face mask (Megatech Surgical Mask). This type of document does not contain the acceptance criteria or a study detailed to prove the device meets acceptance criteria in the way requested for medical device software or AI systems.

Instead, for physical devices like a surgical mask, the "acceptance criteria" are typically related to performance standards like bacterial filtration efficiency, particulate filtration efficiency, fluid resistance, breathability, and flammability. The "study" to prove meeting these criteria would be laboratory testing against recognized standards (e.g., ASTM F2100). The 510(k) clearance itself indicates that the device has been found substantially equivalent to a legally marketed predicate device, implying it meets the same general performance and safety standards.

Therefore, I cannot extract the requested information from this document. The questions posed are most relevant to device performance studies, particularly for diagnostic software, AI, or imaging devices, where sensitivity, specificity, accuracy, and expert review are critical components of the validation process.

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