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The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to the Anti IV Enteral feeding tube. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.

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I am sorry, but the provided text from the FDA 510(k) K083786 for the "CORFLO Anti-IV Enteral Feeding Extension Set" does not contain any information regarding acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

This document is a clearance letter for a traditional medical device (an enteral feeding extension set), not an AI/ML device. The letter focuses on:

• Substantial equivalence to a legally marketed predicate device.
• Regulatory classifications and general controls.
• Contact information for various FDA departments.
• Indications for Use.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions you've asked (about sample sizes, ground truth, experts, MRMC studies, etc.) are highly specific to the evaluation of AI/ML algorithms, which is not applicable to this particular document.

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