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

The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Disposable Medical Face Masks are 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 proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene with steel wire. The proposed devices are sold non-sterile and are intended to be single use. disposable devices.

The provided document is a 510(k) Premarket Notification for a Disposable Medical Face Mask (Model FM-04). This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a full study proving a device meets strict acceptance criteria in a clinical setting in the way an AI/Software as a Medical Device (SaMD) study would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set sample size, how ground truth for training set was established) are not applicable to this type of medical device submission.

The "acceptance criteria" and "reported device performance" here refer to non-clinical performance and safety testing against established standards for medical face masks.

Here's the information extracted from the document relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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