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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. The lubricating or dusting powder used in the glove is excluded.

FINESSIS PERSONAL Latex Powder Free Sterile Surgical Gloves with Protein Claim.

This document is related to the FDA's 510(k) premarket notification for "FINESSIS PERSONAL Latex Powder Free Sterile Gloves with Protein Claim." This is a regulatory clearance document for a medical device (surgical gloves), not a study report for an AI/ML powered medical device.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text because the text describes the regulatory clearance of surgical gloves, not an AI/ML device and its performance study.

The document discusses:

• The trade/device name: FINESSIS PERSONAL Latex Powder Free Sterile Gloves with Protein Claim.
• Regulation Number and Name: 21 CFR 878.4460, Surgeon's Glove.
• Regulatory Class: I.
• Product Code: KGO.
• Indications for Use: 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. The lubricating or dusting powder used in the glove is excluded.

Questions regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth are typically asked for AI/ML diagnostic or prognostic devices that perform specific analyses on data (e.g., images, physiological signals), where "performance" relates to diagnostic accuracy (sensitivity, specificity, AUC) or similar metrics. This document does not describe such a device or study.

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