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The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical Mask is 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.

Disposable Surgical Mask, Ear Loop Type, Size M and S is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The latex free elastic ear loops are made of polyamide fibers and spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of core iron wire with halogen-free polyethylene covering. The Disposable Surgical Mask will be provided in blue of outside and white of inside. The Disposable Surgical Mask is provided non-sterile and for single use.

The provided document is a 510(k) Premarket Notification for a Disposable Surgical Mask (K212944). It describes the device, its intended use, and a comparison with a predicate device, along with non-clinical test results.

However, the questions you've asked are typically relevant to the validation of Artificial Intelligence (AI)/Machine Learning (ML) medical devices, particularly those that involve image analysis, diagnosis, or risk prediction. This document is for a physical medical device (surgical mask) and the submitted information pertains to its physical performance characteristics, not its performance in an AI/ML context.

Therefore, many of your specific questions, such as those related to:

• Ground truth establishment by experts
• Adjudication methods
• Multi-reader multi-case (MRMC) studies
• Standalone algorithm performance
• Training set size and ground truth establishment

are not applicable to the context of this 510(k) submission for a surgical mask. The document does not involve AI/ML.

I can, however, extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria for the surgical mask, based on the provided text.

Acceptance Criteria and Device Performance for Disposable Surgical Mask (K212944)

The device in question is a Disposable Surgical Mask, and its performance is evaluated against established physical and biological standards for medical masks.

Here's a summary tailored to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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