Search Results

The Disposable Surgical Face Masks (model: ZYD-02&ZYD-03) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

Disposable Surgical Face Mask Model No.: ZYD-02 and ZYD-03

This document is a marketing authorization letter from the FDA for a disposable surgical face mask. It verifies that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an AI/ML medical device. The information provided relates to regulatory clearance of a physical medical device (surgical face mask) based on substantial equivalence, not performance evaluation of an AI algorithm.

Therefore, I cannot answer your request based on the provided text. The questions you've asked (regarding multi-reader multi-case studies, standalone algorithm performance, training/test set sample sizes, expert ground truth, etc.) are germane to the evaluation of AI/ML-driven medical devices, for which this document provides no relevant data.

Ask a specific question about this device