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The Single-use Surgical Masks are intended to be worn to protect both the patient 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(s), provided non-sterile.

Single-use Surgical Mask Model FE2311B

This document is a 510(k) clearance letter for a Single-Use Surgical Mask and does not contain information about the acceptance criteria or a study proving the device meets criteria in the way typically associated with AI/ML devices or clinical trials.

The document is a regulatory clearance for a physical medical device (a surgical mask), which goes through a different evaluation process than software or AI-driven diagnostics. The "acceptance criteria" for a surgical mask are typically based on material properties and performance standards (e.g., fluid resistance, particulate filtration efficiency, breathability), which are demonstrated through laboratory testing, not clinical studies with "ground truth" established by experts or MRMC studies.

Therefore, I cannot provide the requested information from this document. The questions posed in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types and training set details) are relevant for evaluating AI/ML medical devices, but not for a conventional surgical mask as described in this FDA clearance letter.

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