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The TotalShield II Zippered Surgical Toga and /or TotalShield II Surgical Hood is for use with the TotalShield II Surgical Helmet and/or TotalShield 11 Surgical Helmet with LED Lighting as the TotalShield II Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

TotalShield II Surgical Helmet System

This document is an FDA 510(k) clearance letter for the TotalShield II Surgical Helmet System. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The letter focuses on the regulatory aspects of device clearance, such as product codes, regulatory class, general controls, and compliance with federal statutes and regulations. It also includes the "Indications for Use" for the device, which describes its intended purpose.

Therefore, I cannot provide the requested information based on the text provided. The document does not contain the details of performance testing or clinical studies.

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