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Cardinal Health™ RoyalSilk™ Surgical Gown is a single use, disposable medical device intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70).

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I am sorry, but based on the provided text, there is no information about a medical device that uses AI or machine learning, nor any details about a study to prove its performance or acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Cardinal Health LLC regarding their RoyalSilk Surgical Gown and RoyalSilk Scrub Nurse Gown. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The content focuses on regulatory information, such as:

• The trade/device name and regulation number
• General controls provisions of the Act
• Requirements for registration, listing, labeling, and medical device reporting
• Information about the regulation entitled "Misbranding by reference to premarket notification"
• Links to FDA resources for medical devices
• Indications for Use for the surgical gowns, specifically stating that the Cardinal Health RoyalSilk Surgical Gown meets the requirements of AAMI Level 3 barrier protection per ANSI/AAMI PB70:2012.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or AI performance, as these topics are not present in the provided text.

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