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The Surgical Gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

This product is a new type of SMS breathable non-woven fabric. It consists of collar, gown body and sleeves. The main components of proposed device are: (1)One-piece non-woven fabric Surgical Gown: (2)One-piece helps for better protection and good visuals; (3)Lacing: It is used to tie the belt and fix the shape of the Surgical Gown.

The provided text is a 510(k) premarket notification for a Surgical Gown (K211077). It describes the device, its intended use, and a comparison to a predicate device, along with non-clinical performance test results.

This document does not describe an AI medical device or a study proving its performance. Therefore, I cannot provide the information requested in the prompt, as the questions pertain to the acceptance criteria and study design for an AI/Machine Learning (ML) medical device, including details about ground truth, expert adjudication, MRMC studies, and training/test set sample sizes.

The document is about a physical product (a surgical gown) and its substantial equivalence to another physical product based on material properties, strength, fluid resistance, etc., not a software-based AI device.

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