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The Surgical Face 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 sterile.

The Surgical Face Masks are Flat Pleated type mask, utilizing Ear straps way for wearing, and they all have Nose clip design for fitting the face mask around the nose. The Surgical Face Masks are manufactured with three layers. The outer layer is made of polypropylene spun-bond non-woven fabric. The middle layer with filtration function is made of polypropylene melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene spun-bond non-woven fabric. The nose clip is made of polyethylene strip with iron wire inside. The ear straps are made of spandex polyester fiber. The Surgical Masks are single use, disposable device, provided sterile.

The provided text is a 510(k) Premarket Notification for a Surgical Face Mask. It details the device's characteristics, comparison to a predicate device, and non-clinical testing results. However, it does not contain information about an AI/ML-based device or a comparative effectiveness study involving human readers.

Therefore, I cannot fulfill your request for information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for the test set and data provenance for an AI/ML device.
• Number of experts and qualifications to establish ground truth for an AI/ML device.
• Adjudication method for an AI/ML device.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size for an AI/ML device.
• Standalone performance for an AI/ML algorithm.
• Type of ground truth used for an AI/ML algorithm.
• Sample size for the training set for an AI/ML algorithm.
• How ground truth for the training set was established for an AI/ML algorithm.

The document focuses on the physical and performance characteristics of a surgical face mask, such as fluid resistance, particulate filtration, bacterial filtration, differential pressure, flammability, and biocompatibility.

Here's the information that is available in the document regarding the physical device (surgical face mask):

1. Table of Acceptance Criteria and Reported Device Performance (for a Surgical Face Mask):

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