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The Laparoscopic Gastrostomy Kit is indicated for use as a means of percutaneously inserting a feeding tube into the stomach through the abdominal wall. The Laparoscopic Gastrostomy Kit is disposable and designed to be used under laparoscopic visualization.

The Applied Medical Laparoscopic Gastrostomy Kit is indicated for use as a means of percutaneously inserting a feeding tube into the stomach through the abdominal wall. The Laparoscopic Gastrostomy Kit is disposable and designed to be used under laparoscopic visualization. The Kit includes (1 each):

• Electrosurgical Obturator / Stylet .
• . 26F Silicone Feeding Tube

This document describes a medical device submission, not a study for an AI/ML powered device. Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC study, standalone performance, training set details) is not applicable or cannot be extracted from the provided text.

The provided text pertains to a 510(k) summary for a medical device (Applied Medical Laparoscopic Gastrostomy Kit) seeking substantial equivalence to predicate devices, not an AI/ML algorithm requiring performance validation against specific acceptance criteria in the manner described. The document states "All testing demonstrates that the Applied Medical Laparoscopic Gastrostomy Kit is equivalent to the predicate devices and introduces no new safety and effectiveness issues when used as indicated." This generally refers to bench testing, biocompatibility, and sterilization validations, which are not typically accompanied by a table of acceptance criteria and device performance in the format requested for AI/ML validation.

Therefore, I am unable to fulfill the request based on the provided input.

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