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The High Fluid-Resistant Surgical and Procedure Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is a single use, disposable device, provided non-sterile.

The High Fluid-Resistant Surgical and Procedure Mask is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose. This device is not made from natural rubber latex.

The provided document is a 510(k) premarket notification for a High Fluid-Resistant Surgical and Procedure Mask, which is a Class II medical device. The study described focuses on benchtop performance testing and biocompatibility testing rather than a clinical study involving human readers or AI. Therefore, most of the requested information regarding AI, human readers, and ground truth establishment in a clinical context is not applicable.

Here's the summary of the acceptance criteria and the study performance for the device itself, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Type 3 mask, as per ASTM F2100. The acceptance criteria and performance data are primarily drawn from Table 2 and Table 3.

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