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Plus Medical Cover Gowns are surgical apparel intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters. The gowns are single use and disposable medical device provided sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization to ISO 1135-1.

Plus Medical Cover Gowns meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

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The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "Plus Medical Cover Gown." This document pertains to the regulatory clearance of a physical medical device (surgical gown) and does not contain information about a software-as-a-medical-device (SaMD) or an AI/ML-based device.

Therefore, I cannot extract the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, MRMC studies, or training sets, as these concepts are specifically relevant to the evaluation of AI/ML algorithms, not to the physical characteristics and testing of a surgical gown.

The document primarily focuses on:

• The device name: Plus Medical Cover Gown
• Regulation number and name: 21 CFR 878.4040, Surgical Apparel
• Regulatory class: Class II
• Product Code: FYA
• Indications for Use: Intended to be worn by healthcare professionals to protect both patients and healthcare workers from the transfer of microorganisms, body fluids, and particulate matters.
• Sterilization: Single use and disposable, provided sterile or sold in bulk for EtO sterilization.
• Performance standard cited: AAMI Level 4 per ANSI/AAMI PB70:2012 for liquid barrier performance.

To answer your request, I would need a document detailing the evaluation of an AI/ML medical device, typically a clinical performance study report or a 510(k) summary for such a device.

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