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A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)

sempermed® SUPREME is a sterile powder-free surgeon's glove. It is a disposable device made of natural rubber inside coated with a layer of polyurethane derivatives, and butadiene-based copolymer cross-linked by polyacrylates- free of process, siliconized. This glove is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. Water soluble protein less than 50 ug/dm2

The provided text is a 510(k) summary for a surgeon's glove and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML device performance. This document is for a physical medical device (surgeon's glove) and focuses on demonstrating substantial equivalence to a predicate device based on material and performance characteristics, not on a data-driven AI/ML model.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are all specific to AI/ML device evaluations and are not applicable to the content provided.

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