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COMBOsafe/Promax Surgical Gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown. COMBOsafe/Promax Surgical Gowns will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

All fabric components used in COMBOsafe™ Surgical Gowns are made from 100% polyester. dyed blue and/or green and are laminated with a urethane film. COMBOsafe Surgical Gowns will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

This request is about a medical device and describes the information to be extracted from the provided text. The provided text is a 510(k) premarket notification for a surgical gown. However, the request asks for information relevant to an AI/ML powered device (e.g., sample size for training set, number of experts for ground truth, adjudication method, MRMC study). These concepts are not applicable to the traditional medical device described in the document.

Therefore, I cannot fulfill the request with the given input. The provided document does not contain any information about an AI/ML powered device, and thus cannot answer the questions regarding acceptance criteria, study design, or performance metrics for such a device.

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