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The Honeywell 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. This is a single use, disposable device, provided non-sterile.

The Honeywell Procedure Mask is composed of three layers that are a flat, pleated style mask with earloops to secure it over the users' mouth and face. The inner and outer layers are manufactured from spun-bond polypropylene. The middle layer is made of melt-blown polypropylene. The mask is a single use, disposable device, provided nonsterile and is not made from natural rubber latex.

The provided text is a 510(k) Premarket Notification for a medical device, specifically the "Honeywell Procedure Mask". It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

However, it's crucial to understand that this document does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the physical and performance characteristics of a surgical mask, not the performance of an AI algorithm in a diagnostic imaging context.

Therefore, many of the requested points related to AI/MRMC studies, such as the number of experts, adjudication methods, effect size, and ground truth establishment for AI training/test sets, are not applicable to this submission.

I will interpret the request in the context of the provided document, focusing on the acceptance criteria and performance testing for the surgical mask device.

Here's the information extracted from the document:

1. A table of acceptance criteria and the reported device performance:

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