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Used to feed nutrients directly into the stomach through a stoma in the abdomen. The tubes are intended as a replacement device and are labeled as such.

Moss Tubes, Inc. All Silicone Gastrostomy Tube

The provided document is a 510(k) clearance letter from the FDA for the Moss Tubes All Silicone Gastrostomy Tube. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on novel performance studies with detailed acceptance criteria as one might find for a new, high-risk device or an AI/ML-based device.

Therefore, I cannot provide the requested table and information based solely on the text provided. The document confirms the device's clearance but does not elaborate on the specific studies and acceptance criteria that would typically be detailed for performance evaluation.

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