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To dilate strictures of the GI tract including the colon, pylorus and esophagus.

The Bard® ELIMINATOR® PET Balloon Dilators are comprised of a radioopaque polyurethanc catheter with an internally fixed guide wire and a high-pressure nondistending PET balloon.

The provided text is a 510(k) summary for the Bard® ELIMINATOR® PET Balloon Dilators. It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

The document states:

• No new biocompatibility testing was performed because there were no material changes.
• Functionality testing, Failure Pressure and Inflation/Deflation testing were completed and demonstrated substantial equivalence to the current device and safety for intended use.

This suggests that the "acceptance criteria" were related to these functional and pressure tests, and the "study" was the performance of these tests, but the specific metrics, thresholds, and detailed results are not provided in this summary.

Therefore, I cannot fill out the requested table or provide details for the study in the format specified because the necessary information is not present in the provided text. The document acts as a summary of the 510(k) application, not the full testing report.

Here's a breakdown of what can be extracted and what cannot based on your request and the provided text:

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

• Cannot be provided. The document mentions "Functionality testing, Failure Pressure and Inflation/Deflation testing were completed," and "demonstrated that the modified Bard® ELIMINATOR® PET Balloon Dilators are substantially equivalent to the current Bard® ELIMINATOR® PET Balloon Dilators and that the device is safe for its intended use and patient population." However, it does not specify the numerical acceptance criteria (e.g., "Failure Pressure > X psi") or the actual reported performance values (e.g., "Failure Pressure was Y psi").

2. Sample sized used for the test set and the data provenance

• Cannot be provided. The document does not specify sample sizes for any of the hinted-at functional or pressure tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned, as these are engineering tests, not clinical studies in humans.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Cannot be provided. This information pertains to studies where expert opinion or clinical assessment forms a ground truth, typically in AI/imaging diagnostics or clinical trials. The tests mentioned (functionality, pressure, inflation/deflation) are engineering performance tests, where ground truth is typically measured against established physical properties or engineering standards.

4. Adjudication method for the test set

• Not applicable / Cannot be provided. Similar to point 3, adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human experts in clinical studies, not for objective engineering tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a physical medical device (balloon dilator), not an AI algorithm or diagnostic tool that would be used by human "readers."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Implied ground truth (engineering specifications/predicate device performance). While not explicitly stated, for "Functionality testing, Failure Pressure and Inflation/Deflation testing," the ground truth would be the pre-defined engineering specifications for the device's performance, or the performance of the legally marketed predicate device (as stated, "substantially equivalent to the current Bard® ELIMINATOR® PET Balloon Dilators"). The document does not provide details on these specifications.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable. There is no "training set."

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