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The VR® Personal Protective Level 3 Gown is intended to protect healthcare patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The VR® Personal Protective Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the VR Gown is open and non-protective. The VR Gown is not intended for use in the operating room.

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The PolyWear® Personal Protection Level 3 Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

The PolyWear® Personal Protection Level 3 Gown meets the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/AAMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).

The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective.

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "PolyWear® Personal Protective Level 3 Gown." This document outlines the regulatory approval for the gown and its intended use, but it does not contain information about acceptance criteria for an AI/ML device, nor does it describe a study proving the device meets such criteria.

The document primarily focuses on:

• Regulatory Classification: Identifying the device as a Class II surgical apparel.
• Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices.
• General Controls: Listing the general regulatory requirements the manufacturer must adhere to.
• Indications for Use: Describing the intended purpose of the gown to protect against microorganisms, body fluids, and particulate material, specifically mentioning it meets AAMI Level 3 barrier protection.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of AI/ML, as this document pertains to a physical medical garment and not a software-based AI/ML device.

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