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The device is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

The disposable rectal speculum is a non-metal (Polypropylene) device used to introduce water into the colon and dispose waste from the colon during a colonic irrigation procedure.

I apologize, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) premarket notification for a colonic irrigation system. It details the device's indications for use, technological characteristics, and claims substantial equivalence to predicate devices. However, it does not describe any specific performance acceptance criteria or a study that directly tests and proves the device meets such criteria.

Instead, the document focuses on:

• Substantial Equivalence: The primary argument for market clearance is that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, indications for use, design, and materials.
• Biocompatibility Testing: It mentions that the finished colonkit was tested for biocompatibility, indicating one type of non-clinical testing performed.

Therefore, I cannot populate the requested table or provide details on the study's methodology, sample size, expert involvement, or ground truth establishment because this information is not present in the provided text.

To answer your question, information about specific performance metrics (e.g., flow rate, safety pressure limits, material strength, etc.), the criteria set for these metrics, and the results of tests designed to meet these criteria would be needed. This depth of information is typically found in design verification and validation reports, which are part of the larger 510(k) submission but are not fully detailed in this summary letter.

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