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A surgeon glove is a disposable device intended for medical purposes that is worn on the surgeon's hand to prevent contamination between patient and surgeon.

The device in this 510(k) submission is the SensiCare -C Synthetic Polyisoprene Powder-free Surgical Glove (Classification number 79KGO). The SensiCare C Synthetic Polyisoprene Powder-free Surgical Glove is a sterile, synthetic rubber latex surgical glove. These gloves are intended to be used as a barrier by providing protection for surgical personnel and patients against microbial migration and to protect a surgical wound from contamination.

The provided text describes the SensiCare-C Synthetic Polyisoprene Powder-Free Surgical Gloves and their regulatory clearance, but it does not contain information about a study involving an AI/Machine Learning device or its performance criteria, ground truth, or expert review process.

The document is a 510(k) summary for a medical glove, focusing on its substantial equivalence to a predicate device and its compliance with relevant ASTM standards for physical properties, sterility, and freedom from holes.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The input does not contain any of the following:

• A table of acceptance criteria and reported device performance for an AI/ML system.
• Sample sizes for test sets, data provenance, or details about training sets for an AI/ML system.
• Information on experts used to establish ground truth or adjudication methods for an AI/ML system.
• Details about Multi-Reader Multi-Case (MRMC) studies or standalone performance of an AI/ML system.
• The type of ground truth used for an AI/ML system.

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