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The EntraCare Gastrostomy Feeding Tube is indicated for use as a replacement gastrostomy tube in an established stoma tract for patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning stomach who require long term feeding support.

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This document is a 510(k) premarket notification for a medical device called the "EntraCare Gastrostomy Feeding Tube." It's a regulatory approval document from the FDA, not a study report or technical specification outlining acceptance criteria and performance data for a device.

Therefore, the requested information about acceptance criteria and a study proving device performance cannot be extracted from this document.

This document primarily states:

• The device name: EntraCare Gastrostomy Feeding Tube
• Its intended use: as a replacement gastrostomy tube in an established stoma tract for patients who cannot consume an adequate diet orally, and who have a functioning stomach requiring long-term feeding support.
• That the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

To provide the requested details, a different type of document, such as a validation study report, clinical trial results, or a technical design specification with performance data, would be needed.

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