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AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON.

AMSure® Cleansing Enema Set

This document, K974042, is a 510(k) premarket notification decision letter for the AMSure® Cleansing Enema Set. It declares the device substantially equivalent to legally marketed predicate devices.

The information provided does not contain the details typically sought when describing acceptance criteria and a study to prove a device meets those criteria in the context of a new, potentially AI-driven, medical device. This is largely because the document pertains to a Class I medical device (a cleansing enema set) cleared in 1997, which would not involve the complex performance studies, statistical analysis, or AI-specific criteria requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria development, study design, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth establishment, or sample sizes related to a performance study for this device based on the given text.

The closest information provided is:

• Device Name: AMSure® Cleansing Enema Set
• Indications For Use: "AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON."
• Regulatory Class: I (21 CFR §876.5210/Product Code: 78 FCE)

For Class I devices like this, substantial equivalence is often based on fundamental design, materials, and intended use being similar to existing legally marketed devices, rather than extensive clinical performance studies as would be required for higher-risk devices or novel AI/software as a medical device. The "acceptance criteria" here implicitly refer to meeting the general controls provisions of the Act and demonstrating substantial equivalence to a predicate device, which would involve showing that the device is as safe and effective as the predicate.

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