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The 3M™ High Performance Surgical Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face mask(s) are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.

The 3M™ High Performance Surgical Mask has a duckbill design consisting of three layers that are comprised of an (polypropylene spunbond) inner and outer cover web and (polypropylene melt blown) filter web. The mask has ties to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. They may be produced with or without a face shield. This is a single use, disposable device, provided non-sterile.

This device is not made with Natural Rubber Latex.

The provided text is a 510(k) premarket notification for a surgical mask, which outlines its substantial equivalence to a predicate device based on performance specifications and safety. It is not a study proving device meeting acceptance criteria in the context of an AI/ML medical device. Therefore, I cannot generate the requested table and information as this document pertains to a physical medical device (surgical mask), not an AI/ML software device.

Key reasons why the request cannot be fulfilled based on the provided text:

• Device Type: The document is about a physical medical device (surgical mask), not a software-based AI/ML device.
• Acceptance Criteria for AI/ML: The acceptance criteria for AI/ML devices typically involve metrics like sensitivity, specificity, AUC, F1-score, etc., and are evaluated against a ground truth established by experts. The criteria here are based on ASTM standards for surgical mask performance (e.g., fluid resistance, particulate filtration, bacterial filtration, flammability).
• Study Design: The document references "nonclinical tests" demonstrating equivalence to a predicate device based on performance specifications. This is not a description of a clinical study or a standalone AI/ML performance study as requested.
• Ground Truth, Sample Sizes, Experts, Adjudication: These concepts are relevant to studies evaluating diagnostic or predictive performance of AI/ML algorithms and are not applicable to the documentation of a surgical mask following ASTM standards.
• MRMC Comparative Effectiveness Study: Such studies compare human performance with and without AI assistance, which is not relevant for a surgical mask.

Therefore, the requested information (table of acceptance criteria with AI/ML performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, standalone performance, and ground truth types) cannot be extracted or inferred from the provided document.

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