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The TTP Jejunostomy Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.

The proposed TTP Jejunostomy Tube consists of a three-port device designed to be placed through a Boston Scientific gastrostomy tube to provide enteral access for decompression and delivery of nutrition and/or medication. The TTP Jejunostomy Tube is available in two tip configurations (pigtail and bent tip) and may be placed by either a pullwire (pull) or guidewire (push) technique. The proposed device is available within a kit which contains the following: a stiffening cannula, a guidewire, lubricating jelly, gauze, a double barbed fitting (attached to stiffening cannula), and a cable tie.

The provided document is a 510(k) summary for a medical device called the "TTP Jejunostomy Tube Kit." This type of submission is for demonstrating substantial equivalence to a predicate device, not for a novel device requiring extensive performance studies with acceptance criteria and ground truth validation in the way that an AI/ML medical device would.

Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth for training/testing sets is not applicable to this document.

Here's why and what the document does state:

• Type of Device: The TTP Jejunostomy Tube Kit is a physical medical device (like a tube and associated accessories) for enteral access. It is not an AI/ML-driven diagnostic or prognostic tool.
• Purpose of Submission (510(k)): The 510(k) submission seeks to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This means it has the same intended use, technological characteristics, and safety/effectiveness profiles as devices already cleared by the FDA.
• Performance Data (Section 7): The document explicitly states: "As this is a request to clarify the indication the performance testing presented in K971906 was not repeated." This means that the current submission relied on the performance data of a previous version of the device (K971906) and other predicate devices, rather than conducting new performance studies for this specific submission. The clarification of indication itself did not necessitate new performance testing.
• Conclusion (Section 8): The conclusion reinforces that the device is substantially equivalent based on its identical technological characteristics to K971906 and its indication to K971906 and K042303.

In summary, there are no acceptance criteria, device performance tables, sample sizes for test/training sets, or details about expert consensus/ground truth determination as would be found for an AI/ML device study, because this submission pertains to a physical medical device seeking substantial equivalence based on prior device data.

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