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

The AIC Disposable Medical Masks are Blue and white color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
The blue colorant is polypropylene (PP) master batch.
The proposed device(s) 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 model of proposed device, tie-on, is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device

This document is a 510(k) Summary for a disposable medical mask, not an AI-powered medical device. Therefore, much of the requested information about acceptance criteria, ground truth, expert adjudication, MRMC studies, and training sets is not applicable to this type of submission.

However, I can extract the relevant non-clinical performance data and the acceptance criteria for those tests, as this is how the device's performance is proven to meet the required standards for a medical mask.

Here's the breakdown based on the provided document, addressing what is applicable:

Device: AIC Disposable Medical Mask
Device Type: Surgical Apparel (Class II Medical Device)

Purpose of the Study: To demonstrate substantial equivalence to a legally marketed predicate device (K153496) by showing that the AIC Disposable Medical Mask is as safe and effective as the predicate device. This is primarily done through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for medical masks are based on recognized standards (e.g., ASTM F2100). The document specifically details the performance against ASTM Level 3 requirements.

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