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The disposable surgical face masks are intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. 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 Kangbeier Surgical Mask (Model: KBR-1001) is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.

The document describes the non-clinical testing performed on the Kangbeier Surgical Mask (Model: KBR-1001) to support its 510(k) submission and demonstrate substantial equivalence to a predicate device. This device is a surgical mask, not an AI-based or image analysis device, therefore, many of the requested items related to AI/MRMC studies, ground truth establishment, and data provenance are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a clear table (Table 2) outlining the acceptance criteria and the results for several non-clinical performance tests.

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