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The Single-use Surgical Masks are 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.

Single-use Surgical Mask Model FE2311B

This document is a 510(k) clearance letter for a Single-Use Surgical Mask and does not contain information about the acceptance criteria or a study proving the device meets criteria in the way typically associated with AI/ML devices or clinical trials.

The document is a regulatory clearance for a physical medical device (a surgical mask), which goes through a different evaluation process than software or AI-driven diagnostics. The "acceptance criteria" for a surgical mask are typically based on material properties and performance standards (e.g., fluid resistance, particulate filtration efficiency, breathability), which are demonstrated through laboratory testing, not clinical studies with "ground truth" established by experts or MRMC studies.

Therefore, I cannot provide the requested information from this document. The questions posed in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types and training set details) are relevant for evaluating AI/ML medical devices, but not for a conventional surgical mask as described in this FDA clearance letter.

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The Single-Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask 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.

Model: M and L, blue color, and Level 3 barrier level as ASTM F2100

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose.

The proposed device(s) are meet Level 3 requirements per ASTM F2100.

The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is blue masterbatch.

The Single-Use Surgical Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polypropylene fiber.

The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.

The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The dimension, the model L is bigger than model M.

The provided document is a 510(k) premarket notification for a Single-Use Surgical Mask, not an AI/ML medical device. Therefore, many of the requested criteria regarding AI/ML model acceptance (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical performance testing and biocompatibility testing, along with a comparison of physical characteristics.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Single-Use Surgical Mask with Ear Loop is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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. Model: M and L, blue color, and Level 2 barrier level as ASTM F2100.

The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven fabric, and the middle layer is made of Melt-blown non-woven fabric. The blue colorant is bule masterbatch. The Single-Use Surgical Mask with Ear Loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made with Polyester. The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices. There are two models included, Model M and L. The two models share the same indication for use, instruction for use, material used, and structure. The only difference is the dimension.

The provided text describes the acceptance criteria and study results for the "Single-Use Surgical Mask with Ear Loop" (K201691), demonstrating its substantial equivalence to a predicate device (K153496).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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