Search Results

The Livocare Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. The surgical mask is a single use, disposable device, provided non-sterile.

The Livocare Surgical Mask is a single use, three-layer, flat-folded mask with ear loops and nose piece. The Surgical Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the surgical mask. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile. This device is not made from Natural Rubber Latex.

The provided text is a 510(k) summary for the Livocare Surgical Mask (K201380). It details the device's technical characteristics, intended use, and comparison to a predicate device (K182515). However, this document does not describe a study involving an AI/Machine Learning device. Instead, it outlines the non-clinical performance testing for a surgical mask, an entirely different type of device.

Therefore, I cannot extract information related to acceptance criteria and studies for an AI/ML device because the provided text is about a physical medical device (a surgical mask).

If you have a document describing an AI/ML device, please provide it, and I will be happy to answer your request.

Based on the provided document for the LIVOCARE SURGICAL MASK:

I will extract the requested information as it pertains to this surgical mask, even though it's not an AI/ML device, to demonstrate the structure of the answer you're looking for, given the limitations of the input.

Acceptance Criteria and Study for Livocare Surgical Mask (K201380)

This document describes the premarket notification for a physical medical device, a surgical mask, not an AI/Machine Learning device. Therefore, the "study" described refers to non-clinical performance testing rather than an AI model's performance. Many of the requested categories are not applicable to the evaluation of a surgical mask (e.g., number of experts for ground truth, adjudication method, MRMC study, training set).

1. Table of acceptance criteria and the reported device performance:

Ask a specific question about this device