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The Surgical Face Mask (Non-sterile) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

The Surgical Face Masks (Non-sterile) are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch.

The inner layer and outer layer of the mask are made of spun-bonded non-woven fabric (polypropylene), the middle layer is made of polypropylene melt-blown non-woven fabric. The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with nylon and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of galvanized iron wire coated by PE.

The Surgical Face Mask (Non-sterile) is sold non-sterile and are intended to be single use, disposable devices.

The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.

The document provided is a 510(k) Pre-market Notification for a Surgical Face Mask (Non-sterile). It outlines the non-clinical testing performed to establish substantial equivalence to a predicate device. This type of submission relies on performance testing against established standards rather than clinical studies for device functionality.

Here's a breakdown of the requested information based on the provided text:

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

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The masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult 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 proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. It is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of polyester and polyurethane, not made from natural rubber latex. The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is made of polyethylene.

The proposed device is provided non-sterile and is intended to be a single use, disposable device.

The provided text is a 510(k) Summary for a Surgical Face Mask. It outlines the device, its intended use, and comparative data against predicate and reference devices to demonstrate substantial equivalence. However, this document does not describe the specific study design elements typically associated with proving a device meets acceptance criteria for an AI/ML-based medical device, as requested in the prompt.

The document details performance testing for physical characteristics of a surgical face mask (e.g., fluid resistance, filtration efficiency, flammability, biocompatibility), which are relevant for demonstrating the safety and effectiveness of the mask itself. It does not contain information about an AI/ML algorithm or its performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the AI/ML device meets the acceptance criteria based on the provided text. The text is for a physical medical device (surgical face mask), not an AI/ML device.

If the request was simply to describe the acceptance criteria and study proving the surgical face mask meets its criteria, the following information can be extracted:

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

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The Surgical Face Mask (non-sterile) 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 a single use, disposable device(s), provided non-sterile.

The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of nylon and spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

Here's a breakdown of the acceptance criteria and study information for the "Surgical Face Mask (non-sterile)" as presented in the FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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