Search Results

The Procedure Masks / Surgical Masks are intended to be worn to protect both the patient and healtheare 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.

The Procedure Masks / Surgical Masks with Polyethylene nose wire can be used in MRI environment.

Procedure Mask / Surgical Mask, Ear loops and Tie-On. This is a single use, disposable device(s), provided non-sterile.

The provided text is a U.S. FDA 510(k) clearance letter for a Procedure Mask/Surgical Mask. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain any information regarding the acceptance criteria, device performance testing (including details on sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details) for an AI/ML-driven device.

This document pertains to traditional medical device clearance (a surgical mask), which goes through a different evaluation process than AI/ML-driven software as a medical device (SaMD). The questions you've asked are highly relevant to the regulatory clearance of AI/ML-driven medical devices, but the provided text does not offer this information.

Therefore, I cannot fulfill your request using the given input, as the necessary information is absent.

Ask a specific question about this device