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The device is a low profile replacement gastrostomy tube kit designed for percutaneous insertion through an established stoma tract.
The device is indicated for percutaneous placement of a low-profile long term gastrostomy feeding and decompression device through an established stoma.

The Low Profile Gastrostomy Tube Kit is a collection of medical devices that are assembled for the convenience of the health care professional for the purpose of creating a percutaneous gastrostomy through which an enteral feeding tube is placed. The Kit contains items that are commonly used in this type of procedure and which otherwise would be procured through the facility's central supply system. The units are packaged in a kit form with related feeding components and is ethylene oxide sterilized. It is packaged in a preformed plastic tray, and is sealed with a 1073B tyvek lid containing a description of the kit components. This packaging is similar to the predicate unit and is a system commonly used in the medical device industry.

The provided text describes a 510(k) summary for the "Radius Low Profile Gastrostomy Tube Kit." This document explains the device, its intended use, and its comparison to a predicate device for regulatory purposes. However, it does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or any of the detailed analytical performance metrics typically associated with a medical device study.

The document is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical or performance study report.

Therefore, I cannot fulfill your request with the provided input text. To answer your questions, I would need a different document, such as a clinical study report or a detailed performance verification and validation report for the device.

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