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The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system.

The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system. The major components of the Flexima Biliary Catheter are the drainage catheter, metal stiffening cannula, flexible stiffening cannula and luer cap.

The provided text is a summary of a 510(k) premarket notification for the Flexima™ Biliary Catheter.

This document DOES NOT contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness study (MRMC or standalone AI performance).

The document focuses on demonstrating substantial equivalence to a predicate device. This typically involves performance testing to show the new device functions similarly to the existing device, but it doesn't usually include the kind of detailed clinical study information (like ground truth establishment, expert adjudication, or AI performance metrics) requested in your prompt, especially for a non-AI medical device like a biliary catheter.

Therefore, I cannot fulfill your request for the specific details you've asked for, as they are not present in the provided text.

Here's an explanation of why the requested information is absent based on the document:

• Type of Device: The Flexima Biliary Catheter is a physical medical device for drainage, not an AI or imaging-based diagnostic tool. The performance criteria for such devices typically revolve around mechanical properties, biocompatibility, and functional equivalence, rather than diagnostic accuracy metrics.
• Regulatory Pathway (510(k)): The 510(k) pathway, particularly a Special 510(k) in this case, primarily aims to demonstrate "substantial equivalence" to a legally marketed predicate device. This often involves bench testing, limited animal studies, or comparison of design specifications, rather than large-scale human clinical trials or complex AI performance evaluations.
• Content of the Summary: The provided text is a "Summary of Safety and Effectiveness" which briefly outlines the device, its intended use, and states that "All data gathered demonstrate this device as substantially equivalent." It does not elaborate on the specific tests or their results.

To directly address your prompt points, given the provided text, I can only state that this information is not available:

1. A table of acceptance criteria and the reported device performance: Not provided. The document generally states "All data gathered demonstrate this device as substantially equivalent," but no specific performance criteria or results are listed.
2. Sample size used for the test set and the data provenance: Not provided. The type of testing and sample sizes are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth in this context (for a physical catheter) would likely relate to objective measurements of device properties rather than expert consensus on diagnostic images.
4. Adjudication method: Not applicable/Not provided.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used: Not applicable/Not provided.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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