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The McLean-Ring Nasojejunal Feeding Tube Set is intended for enteral feeding and medication in adult and pediatric populations. The device is intended to be used in the treatment of the following pediatric subgroups: children and adolescents.

The McLean-Ring Nasojejunal Feeding Tube Set is composed of a feeding tube and wire guide. The feeding tube is made of a 9.5 French polyurethane tube. The feeding tube is available in 130 centimeters only, measured from the distal tip to the proximal hub. The distal end of the feeding tube features six sideports. The distal tip of the feeding tube is open with a smooth round finish. A 0.650-inch long stainless steel weight is fit outside the distal end of the feeding tube and is completely covered with a shrink tube, forming 0.180-inch outer diameter over the weight. The proximal end of the feeding tube features a hub with a cap that is made of polyurethane. The wire guide is made of stainless steel in a 0.038-inch diameter. The wire guide is 275 centimeters long. In addition, the entire length of the wire guide is coated with PTFE. The distal end of the wire guide is straight but flexible. The subject device, McLean-Ring Nasojejunal Feeding Tube Set, may be introduced directly when there is adequate peristalsis and no gastric outlet obstruction. Alternatively, the feeding tube may be passed over a wire guide. The feeding tube is intended to be indwelling up to 30 days and is for one-time use.

The provided document is a 510(k) Premarket Notification from Cook Incorporated for the McLean-Ring Nasojejunal Feeding Tube Set. It describes the device, its intended use, and its comparison to a predicate device (Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube).

Critically, this document describes a medical device, specifically a feeding tube, not an AI/ML-based medical device. Therefore, the concepts of "acceptance criteria for an AI/ML device," "study proving the device meets acceptance criteria for an AI/ML device," "sample size used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "training set," and "how ground truth for training set was established" are not applicable to the information provided.

The document focuses on the substantial equivalence of a physical medical device. The "studies" mentioned are bench testing to assure reliable design and performance (e.g., dimensional, flow rate, kink resistance, MRI compatibility) and biocompatibility testing. Additionally, clinical evidence is provided through a review of published literature on the use of similar feeding tubes in pediatric patients. This literature review is used to support the safety and performance for the device's intended use in children and adolescents, not to prove the performance of an AI algorithm.

Since the request is about an AI/ML device and the provided text describes a physical medical device, I cannot extract the requested information.

If you have a document describing an AI/ML medical device, please provide it, and I will be able to answer your questions accordingly.

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