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To provide nutrition directly into the stomach through an established stoma in a patient who is unable to consume nutrition by conventional means.

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This FDA letter is a 510(k) clearance for a medical device (AMT G-Tube Balloon Replacement Gastrostomy Tube), not a study report. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or other details typically found in a study proving a device meets acceptance criteria.

The letter primarily states that the FDA has reviewed the manufacturer's notification and determined the device is substantially equivalent to legally marketed predicate devices. This means it has similar indications for use and technological characteristics to a device already on the market and does not raise new questions of safety and effectiveness.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report. This 510(k) clearance letter does not provide the requested information.

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