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The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, these 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 non-sterile.

The Surgical Face Masks are 3-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (Spandex) or ties (polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask will be provided in blue, white, pink, green, vellow and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.

The provided document is a 510(k) summary for a Surgical Face Mask and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information related to an AI/ML powered device, comparative effectiveness studies (MRMC), or clinical studies with human readers. Therefore, several requested sections, such as those pertaining to AI/ML, human expert involvement, and ground truth establishment from clinical data, are not applicable based on the provided text.

Here’s an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Surgical Face Mask, and the performance is evaluated based on ASTM and EN standards relevant to such masks. There are three levels of surgical face masks (Level 1, Level 2, and Level 3), each with specific acceptance criteria. The test results consistently show that the device "PASS"es all specified criteria.

Level 1 Surgical Face Mask (Model: SQ-1001)

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