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The Surgical 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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Mask is a single use, Flat Pleated mask with ear loops and nose piece. The Surgical Mask is consisting of three layers, the inner and outer layers are made of spunbonded polypropylene, and the middle layer is made of melt blown polypropylene filter. The Surgical Mask uses different colors to distinguish the inner and outer layers, the inner layer is white and the outer layer is blue. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire. The Surgical Mask is sold non-sterile and is intended to be single use, disposable devices.

This document describes the premarket notification (510(k)) for a Surgical Mask (K201852) and its substantial equivalence to a predicate device (K182515). The information provided focuses on non-clinical performance testing to demonstrate this equivalence. Since this is a submission for a Surgical Mask, the "device" in the context of your request refers to the surgical mask itself, not an AI or software-based medical device.

Therefore, many of the questions you've asked, which are typically relevant for AI/ML-based medical devices, are not applicable to this submission. This document does not describe an AI/ML device that requires a test set, ground truth established by experts, MRMC studies, or training sets.

Here's an analysis based on the provided document:

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

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