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The Wilson-Cook Biliary Dilation Balloon is intended to dilate strictures in the biliary tree. This device is supplied sterile and intended for single use.

The proposed Wilson-Cook Biliary Dilation Balloon is a triple lumen catheter with a balloon mounted on the distal tip. The three lumens allow one lumen for wire guide access and two lumens for inflation/deflation of the balloon when placed through the accessory channel of an endoscope. The balloon is inflatable with water to nominal pressures to exert force on biliary strictures resulting in stricture dilation. It is offered in a variety of diameters to accommodate a range of biliary strictures

The provided text describes a 510(k) premarket notification for a medical device called the "Wilson-Cook Biliary Dilation Balloon." It outlines the device's intended use, description, and comparison to predicate devices, focusing on the substantial equivalence argument for regulatory approval. However, it does not contain any information regarding specific acceptance criteria, study details, or performance metrics beyond a general statement about "Non-Clinical Testing."

Therefore, I cannot provide the requested table or detailed answers to questions 2 through 9.

Here's an explanation of what can be extracted and why the other information is missing:

1. A table of acceptance criteria and the reported device performance:

Explanation for missing data:
The 510(k) summary provided is a high-level overview for regulatory submission. It focuses on demonstrating substantial equivalence to existing predicate devices. While it mentions that "Non-Clinical Testing" was performed to verify safety and performance, it does not include the detailed results of engineering tests, bench tests, or clinical studies that would contain specific acceptance criteria and performance data (e.g., burst pressure, inflation/deflation times, material strength, fatigue testing, etc.). These details are typically found in the full 510(k) submission, which is much more extensive than this summary.

As a result, I cannot answer questions 2 through 9 because the provided text does not contain the necessary information. This includes:

• Sample size used for the test set and the data provenance: Not mentioned. The testing was non-clinical, so there wouldn't be a "test set" in the sense of patient data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was non-clinical testing.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned, and highly unlikely for a device of this nature in a 510(k) submission, especially a non-clinical one.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: Not explicitly stated beyond "safety and performance" verified through non-clinical testing.
• The sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory approval document for a physical medical device, not an AI/software device that would typically involve the detailed study characteristics you've requested. The "Performance Data" section briefly notes that non-clinical testing was done, but does not elaborate on the specific criteria or results.

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