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The Seidmon Antegrade AQ Stent is internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent as well as providing external drainage in patients age 18 years and older when treated as adults.

The Seidmon Antegrade AQ Stent Set contains a nephroureteral stent with hydrophilic coating, a Luer lock drainage adapter, and a Peel-Away Introducer. The stent tubing is made of radiopaque polyurethane and is provided in 6.0 French diameter with 50 centimeters in overall length (28 centimeters ureteral working length). The Luer lock drainage adapter is to be used with a drainage bag to provide the external drainage. The Peel-Away Introducer consists of a polyethylene dilator and a tetrafluoroethylene sheath, which is used to facilitate percutaneous placement of the nephroureteral stent. The dilator is provided in 8.0 French diameter and 37 centimeters length. The sheath is provided in 10.0 French diameter and with 32 centimeters working length.

The provided text is a 510(k) Premarket Notification for a medical device called the "Seidmon Antegrade AQ Stent Set." This document describes the device, its intended use, and its comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not contain the acceptance criteria and detailed study information required to answer your specific questions in the requested format. It broadly states that "All predetermined acceptance criteria of the testing were met," but it does not specify what those criteria were, nor does it provide the results of any specific studies in a quantifiable manner as you requested.

The document lists the types of tests conducted (e.g., Sterilization, Biocompatibility, Dimensional Verification, Pigtail Restoration, Curl Retention, Tensile, Lubricity, Functional Use Flow Rate and Liquid Leakage, Radiopacity, MR Imaging Safety, Shelf Life/Stability), but it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance. Only the device specifications (e.g., 6.0 French diameter, 50 cm length) are mentioned.
3. Number of experts and their qualifications for ground truth establishment. This type of information is usually relevant for AI/software devices, which this stent set is not.
4. Adjudication method. (Again, primarily relevant for AI/software evaluations).
5. MRMC comparative effectiveness study results. The device is not an AI algorithm.
6. Standalone performance. (Not applicable for this type of device in the AI context).
7. Type of ground truth used. (Not applicable).
8. Sample size for the training set. (Not applicable as it's a physical device, not an AI model).
9. How ground truth for the training set was established. (Not applicable).

In summary, the provided text describes a physical medical device (a ureteral stent set) and the process of demonstrating its substantial equivalence to a predicate device through various performance and safety tests. It does not involve an AI algorithm or software and therefore does not contain the information typically required for evaluating AI device performance as per your detailed questions.

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