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The Moss P. E. G. Tray is used to place a tube through the abdominal wall and into the lumen of the stomach (and/or beyond) without open surgery. The procedure provides a channel for providing nourishment directly into the digestive system for patients who cannot swallow (e.g. after stroke). An independent channel can be suctioned to remove excess feedings, swallowed air, or other fluids that might distend the stomach and lead to vomiting.

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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Moss P.E.G. Tray, indicating substantial equivalence to a predicate device.

It includes:

• Device Name: Moss P.E.G. Tray (Percutaneous Endoscopic Gastrostomy Tray)
• Regulatory Class: II, 21 CFR 876.5980/Procode: 78 KNT
• Indications for Use: To place a tube through the abdominal wall into the stomach for nourishment, and to remove excess feedings, air, or fluids.
• Date of Clearance: March 17, 1999

However, it does not provide details about:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or details of a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a study report or clinical trial summary.

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