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This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Non-sterile, Powder-free Nitrile Examination Glove with Polymer coating, Aloe and Vitamin E. Blue.

The provided text describes a 510(k) summary for a Nitrile Examination Glove, not a medical imaging AI device. Therefore, it does not contain information related to acceptance criteria, study methodologies (like sample size, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) typically associated with the development and validation of AI models for medical imaging.

The document focuses on demonstrating substantial equivalence of a new glove product to existing predicate devices based on material, intended use, physical properties, and biocompatibility.

Therefore, I cannot extract the requested information as it is not present in the provided text.

If you have a document describing an AI device for medical imaging, please provide that, and I will be happy to extract the relevant details.

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