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The Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube is a percutaneously placed gastrostomy feeding device used to administer nutrition directly into the stomach.

The device is available in either the guidewire or pullwire method. The domed shaped internal bolster is injection molded onto clear medical grade silicone tubing. The tubing has graduated markings which allows for verification of tube positioning. The internal bolster is also composed of medical grade silicone but which has been pigmented with barium sulfate which provides radiopacity. The internal bolsters' shape allows for ease of passage during placement and is advantages because it permits passage of a jeujenostomy tube if jeujenal feeding is required.

The provided 510(k) summary for the Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube does not contain any information related to acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML-based device.

The summary describes a traditional medical device (a PEG feeding tube) and focuses on its substantial equivalence to existing devices based on its design, materials, and intended use.

Therefore, I cannot provide the requested information. The document does not discuss:

• Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• Any study involving a test set, ground truth, or expert evaluation.
• Multi-reader multi-case studies or standalone algorithm performance.
• Training sets for an AI/ML model.

This is a traditional medical device submission, not an AI/ML device submission.

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