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

The subject device is three-layers, flat-pleated mask constructed of nonwoven polypropylene materials, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene. The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex. A zinc wire nose piece with polypropylene coating is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose. The subject device is provided in blue color. The blue colorant is made of polypropylene master batch. This subject device is provided with size 17.5 cm ± 0.5 cm. The subject device is single-use, disposable device, provided non-sterile.

The provided text is related to the FDA 510(k) premarket notification for a medical face mask, not an AI/ML medical device. Therefore, a direct response to your detailed questions regarding acceptance criteria, study design for AI/ML devices, and ground truth establishment is not applicable. The information describes the performance testing of a physical product (medical face mask) against established industry standards.

However, I can extract the acceptance criteria and the device's performance based on the provided document as it pertains to the Perfetta Moderate Medical Face Mask.

1. Table of Acceptance Criteria and Reported Device Performance

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