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The S.M.A.R.T. ® RE-FLEX™ Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

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This document is an FDA 510(k) clearance letter for a medical device called "The S.M.A.R.T. RE-FLEX™ Biliary Self Expanding Stent System". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed information necessary to describe acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed premarket submission documents.

The provided text is an FDA clearance letter, which is a regulatory decision document. It states that the device is substantially equivalent and can be marketed, but does not explain the data leading to that conclusion in the format requested.

Therefore, I cannot populate the table or answer most of the questions based on the input provided. The document primarily focuses on regulatory approval, labeling requirements, and general controls, not on the specifics of performance testing or clinical study results.

Here's what can be extracted and what cannot:

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

• Cannot be provided. This document does not specify acceptance criteria (e.g., specific clinical endpoints, success rates, patency rates) or detailed performance results in a quantitative manner.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided. This information is not present in the FDA clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable/Cannot be provided. This type of detail is relevant for studies involving human interpretation (e.g., medical imaging AI), not typically for a self-expanding stent device in this context where "ground truth" would be related to clinical outcomes or device functionality established through different types of studies (e.g., mechanical testing, animal studies, human clinical trials). The document mentions no such experts or ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable/Cannot be provided. Similar to point 3, this is for studies involving human interpretation.

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/Cannot be provided. This type of study relates to AI-assisted diagnostic or interpretative devices. The S.M.A.R.T. RE-FLEX™ Biliary Self Expanding Stent System is a physical interventional device, not an AI diagnostic tool.

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

• Not applicable. This pertains to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cannot be provided. The document does not describe the types of data (e.g., clinical trial results, pathology) that would have established the ground truth for the performance claims in the actual submission to the FDA.

8. The sample size for the training set

• Not applicable/Cannot be provided. This applies to machine learning models, not to a physical medical device like a stent.

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

• Not applicable/Cannot be provided. This applies to machine learning models.

In summary: The provided FDA 510(k) clearance letter serves as proof of regulatory approval based on substantial equivalence, but it is not the study report itself. The detailed clinical or performance study data (including acceptance criteria, sample sizes, and specific results) that informed this FDA decision would be found in the actual 510(k) submission and associated technical reports, which are not included in this extract.

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FlexStent® Biliary Self-Expanding Stent System is indicated for the palliation of malignant strictures in the biliary tree.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device (FlexStent® Biliary Self-Expanding Stent System). It confirms the device's substantial equivalence to a predicate device for a specific indication (palliation of malignant strictures in the biliary tree).

However, this document does not contain any information about acceptance criteria for device performance, study details, or ground truth establishment. The letter is solely focused on regulatory clearance based on substantial equivalence, and it explicitly states that "The safety and effectiveness of this device for use in the vascular system have not been established." This indicates that the 510(k) process relied on demonstrating equivalence to a previously approved device, rather than providing new clinical performance data against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or the number/qualifications of experts.
• Adjudication methods.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth used.
• Sample size for the training set or how its ground truth was established.

This is a common characteristic of 510(k) clearances, which often do not require new clinical studies if substantial equivalence can be demonstrated through other means (e.g., performance testing, comparison to predicate device characteristics).

Ask a specific question about this device