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The Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons 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, provided non-sterile.

Face Masks intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

The provided text does not describe an AI/ML device but rather a surgical mask (Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons). Therefore, the information requested for AI/ML devices, such as sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable and cannot be extracted.

However, I can provide the acceptance criteria and the reported device performance for the surgical masks based on the provided text, as these are relevant to non-AI/ML medical devices.

1. A table of acceptance criteria and the reported device performance (for the Surgical Mask):

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