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The MTP Hamou Endomat Disposable Tubing Sets are intended for use by qualified surgeons for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures.

The MTP Hamou Endomat Disposable Tubing Set is intended to be utilized with the Karl Storz Hamou Endomat Irrigation System for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures.

The MTP Hamou Endomat Disposable Tubing Sets are intended for use by qualified surgeons for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures. The body contact materials are PVC, silicone, polyolefin, and Makrolon.

The provided document is a 510(k) Summary of Safety and Effectiveness for the MTP Hamou Endomat Disposable Tubing Sets. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance data for the device itself.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, ground truth type for test and training sets, training set sample size, and ground truth establishment for training set) is not available in the provided text.

The document states:
"The MTP Hamou Endomat Disposable Tubing Sets are substantially equivalent to the predicate device since the basic features, design and intended uses are the same."

This means the submission relies on the established safety and effectiveness of a previously cleared device (the predicate device) because the new device shares fundamental characteristics and intended use. There is no new performance study described in this 510(k) summary.

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