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A powder-free sterile surgeon's glove is a disposable device made of de-proteinised latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Eclipse, Non-pyrogenic, latex, powder free, sterile surgeon's glove

The provided document is a 510(k) premarket notification letter for a surgeon's glove, which is a medical device. This type of document does not contain information about acceptance criteria and study data for an AI/ML-powered medical device. It pertains to traditional medical device clearance based on substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information from the provided text. The questions posed are related to the evaluation of AI/ML device performance, which requires a different kind of documentation (e.g., a clinical study report, detailed performance testing results).

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