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DermAssist ™ Fluid Resistant Surgical Mask / Procedure Mask is a high filtration 3 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials.

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This document is a 510(k) clearance letter from the FDA for a surgical mask. It does not contain information about acceptance criteria or a study proving device performance in the way typically found for AI/ML powered medical devices. The clearance is based on substantial equivalence to a predicate device, not on specific performance metrics derived from a study like those described in your questions.

Therefore, I cannot extract the requested information from the provided text. The questions you've asked are relevant for AI/ML devices, but this document pertains to a traditional medical device (a surgical mask).

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DermAssist ™ Fluid Resistant Surgical Mask / Procedure Mask is a high filtration 4 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials.

DermAssist ™ Fluid Resistant Surgical Mask (Tie On Style) / Procedure Mask (Ear Loop Style)

The provided text is a 510(k) clearance letter for a surgical mask. It does not contain information about acceptance criteria, device performance, study design, or ground truth for an AI/ML powered medical device. Therefore, I cannot generate the requested table and information.

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DermAssist ™ Fluid Resistant Surgical Mask / Procedure Mask with WrapAround Visor is a high filtration 4 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials. The WrapAround Visor is a 3M ® Anti Fogging Visor, is intended to act as a face shield or an eye shield, during instances where blood and bodily fluids may be splashed upon the surgeon or medical healthcare personnel.

DermAssist ™ Fluid Resistant Surgical Mask (Tie On Style) with WrapAround Visor / Procedure Mask (Ear Loop Style) with WrapAround Visor

I am sorry, but based on the provided document, the information required to answer your request is not available. The document is a 510(k) clearance letter from the FDA for a surgical mask and visor, indicating substantial equivalence to a predicate device. It does not contain details about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies that would be expected for an AI/ML device.

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