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The Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination.

Polyisoprene Powder Free, Black Colour Surgical Gloves Model 1: 0.22 mm Model 2: 0.30 mm

Based on the provided FDA 510(k) clearance letter (K192933) for "Polyisoprene Powder Free, Black Colour Surgical Gloves," none of the requested information regarding acceptance criteria, study details, expert involvement, or ground truth establishment for a device that uses AI analysis is available.

This document is a clearance letter for a physical medical device (surgical gloves), not an AI/ML-enabled diagnostic or analytical device. The letter pertains to the substantial equivalence of the gloves to previously marketed predicate devices under the Federal Food, Drug, and Cosmetic Act.

Therefore, I cannot provide details on:

• A table of acceptance criteria and reported device performance (for AI)
• Sample size used for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study or effect size
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document only covers regulatory information for the surgical gloves, such as:

• Trade/Device Name: Polyisoprene Powder Free, Black Colour Surgical Gloves
• Regulation Number: 21 CFR 878.4460
• Regulation Name: Non-Powdered Surgeon's Glove
• Regulatory Class: Class I, reserved
• Product Code: KGO
• Indications for Use: "The Polyisoprene Powder Free, Black Colour Surgical Gloves are radiation attenuating and intended to be worn by operating room personnel to protect a surgical wound from contamination."

In summary, the provided text does not contain any information related to the performance evaluation or validation of an AI-powered device.

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