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Modulap™ Probe Tips may be used with legally-marketed trumpet valves designed to provide pressurized irrigation solution to the operative site during laparoscopic/endoscopic procedures. The hollow channel present in some of the Modulap™ Probe Tips can also be used to introduce other laparoscopic instruments into the surgical site.

When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, and Trumpet Valve, the Candidate Device communicates the Trumpet Valve's suction and irrigation capabilities to the operative site during general laparoscopic surgical procedures.

This 510(k) submission describes an aspiration/irrigation cannula called "ModulapTM". The device is a relatively simple surgical tool. The provided text does not include information about acceptance criteria or a study proving the device meets said criteria.

It only describes the device's function, scientific basis, physical/performance characteristics, and intended use. There is no mention of any quantitative performance metrics, clinical trials, or any form of study results.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is absent from the provided text.

The closest information provided is about its "Technological Characteristics Summary" which indicates it's a hollow tube and connector used to communicate suction and irrigation capabilities. This is a descriptive summary of its design, not a performance study result.

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