Search Results

This single-use face mask covers the wearer's nose and mouth, providing a general physical barrier to protect the wearer from the environment, and the environment from the wearer. This device is designed to spatter of blood and other infectious materials.

Not Found

This document describes the 510(k) premarket notification for 3-Layer Medical Face Masks (XMM3L3C) and 3-Layer Medical Face Masks with ties (XMM3HT).

This document does not contain information about an AI/ML-driven medical device. Instead, it is a clearance letter for standard medical face masks. Therefore, I cannot extract any information related to acceptance criteria, study details, expert qualifications, or ground truth establishment for an AI/ML device from the provided text.

The closest relevant information, though not directly applicable to an AI/ML device's performance, is the "Indications for Use" section on page 2. It states: "This single-use face mask covers the wearer's nose and mouth, providing a general physical barrier to protect the wearer from the environment, and the environment from the wearer. This device is designed to spatter of blood and other infectious materials."

To fulfill your request for information on acceptance criteria and study proving device performance for an AI/ML device, I would need a different document that pertains to such a device.

Ask a specific question about this device