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ENPOLE is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.

The Bladeless Trocar is a sterile single patient use instrument consisting of a sleeve in sizes from 5 mm to 12 mm diameters. The trocar sleeve for the devices contains two seal, an outer integrated self-adjusting seal that accommodates instruments ranging from 5 mm to 12.5 mm in diameter where indicated and an internal seal. Together, these seal minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5 mm trocar sleeve accommodates only 5 mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. Bladeless trocar is access into the abdomen of laparoscopy that is particular to the insertion of surgical instruments through small incisions. The sleeve penetrated into the intra- abdominal by the obturator is inserted and fixed in the abdominal wall, which is a principle that allows laparoscopy to be performed at a constant abdominal pressure state by keeping it sealed to the outside of the human body.

The provided document describes the FDA 510(k) clearance for the ENPOLE® Bladeless Trocar, a single-use medical device used to create a port for inserting endoscopic instruments during endoscopic procedures. It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML powered device. The "Performance Data" section lists several physical and functional tests, but the criteria are generically stated as "Internal standard" and the results as "Pass".

Therefore, I cannot fulfill your request for information regarding AI/ML related acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement as this document pertains to a traditional medical device (bladeless trocar) and not an AI/ML-powered one.

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