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The AMSure Foley Insertion Tray is intended for use in the drainage of urine from the bladder

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This is a 510(k) premarket notification for a medical device called the "AMSure™ Foley Insertion Tray", not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are specific to AI/ML device evaluations, are not applicable and cannot be extracted from this document.

The document focuses on the FDA's determination of substantial equivalence for a physical medical device (Foley Insertion Tray) to a legally marketed predicate device. The review process outlined here does not involve performance studies in the way an AI/ML algorithm would be evaluated. It addresses regulatory compliance, manufacturing practices, and the classification of the device and its components (including the drug component Povidone Iodine Swabsticks).

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