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

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "FlexStent® Biliary Self Expanding Stent System".

The letter primarily:

• Confirms the device's substantial equivalence to a legally marketed predicate device.
• Specifies limitations on its labeling, particularly regarding its use in the vascular system and the prominent display of its biliary indication.
• Outlines general regulatory requirements for the manufacturer.
• Provides contact information for further regulatory guidance.

The "Indications for Use" section (page 2) simply states the intended use of the device ("palliation of malignant strictures in the biliary tree") but does not include any performance metrics, study details, or acceptance criteria.

Therefore, I cannot provide the requested table or details about a study from this document.

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

Not Found

This document is a 510(k) clearance letter for the FlexStent® Biliary Self Expanding Stent System, indicating it has been found substantially equivalent to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria, which would typically be found in a detailed study report or a summary of safety and effectiveness.

Therefore, I cannot provide the requested information from the provided text. The document is primarily an FDA communication approving the device for marketing with specific labeling limitations.

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

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for the FlexStent® Biliary Self Expanding Stent System. It approves the device as substantially equivalent to legally marketed predicate devices for the palliation of malignant strictures in the biliary tree.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter is an approval based on a substantial equivalence determination, not a detailed report of clinical study results.

Therefore, I cannot fulfill your request for the specific information laid out in your prompt based on the provided text. The document confirms the regulatory approval for marketing, but it does not detail the technical performance and study design data that would typically be found in a clinical study report or a more comprehensive FDA submission summary.

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Ask a specific question about this device

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).

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