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The Stomach (Gastric) Tube is intended for gastric decompression, gastric lavage, and administration of nutritional supplements and medication.

All Silicone Stomach (Gastric) Tube (Model 2020)

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific criteria. The text is a 510(k) clearance letter from the FDA for a device called "All Silicone Stomach (Gastric) Tube (Model 2020)".

This letter primarily focuses on:

• Device Name: All Silicone Stomach (Gastric) Tube (Model 2020)
• Regulatory Information: Regulation number, name, and class.
• Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• General Controls: Requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Indications for Use: Gastric decompression, gastric lavage, and administration of nutritional supplements and medication.

The document does not include details on:

1. Acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. Ground truth establishment for the training set.

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