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The Edwards Lifesciences LifeStent FlexStar Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

The LifeStent FlexStar Biliary Stent System consists of a self-expanding stent that is provided loaded into an over-the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging turnor. The flexible, self-expanding stent is made by laser cutting an open lattice design into a nitinol tube. The subject device is supplied in lengths of 20mm to 80mm and diameters of 6mm to 10mm.

The provided text describes a 510(k) premarket notification for the LifeStent FlexStar Biliary Stent System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing de novo performance criteria or conducting clinical trials to prove device performance against specific acceptance criteria.

Therefore, the document does not contain information regarding traditional acceptance criteria or a study designed to prove the device meets such criteria.

Instead, it focuses on demonstrating that the new device is substantially equivalent to predicate devices already on the market.

Here's a breakdown of why the requested information cannot be fully provided based on the input text:

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

• Not applicable for a 510(k) submission based on substantial equivalence. The document states: "Edwards Lifesciences completed bench testing such as deployment testing, dimensional testing, as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the system performed in a manner substantially equivalent to the predicate devices cited in item 7 above." This indicates the tests were to show similarity, not to meet pre-defined performance acceptance criteria unique to this device against a new standard.

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

• Not provided. The document only mentions "bench testing" without specifying sample sizes for these tests. Data provenance like country of origin or retrospective/prospective is not relevant to bench testing.

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. Bench testing does not involve establishing ground truth through expert consensus.

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

• Not applicable. Adjudication methods are typically for clinical studies or image interpretations, not bench testing of material properties.

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 device is a physical medical implant (biliary stent), not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This is not an algorithmic device.

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

• Not applicable. Bench testing for substantial equivalence evaluates physical and performance characteristics against a known predicate, not against a "ground truth" in the clinical sense.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning, so there is no "training set."

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

• Not applicable. As above, no training set or ground truth in this context.

Summary of available information related to performance:

• Type of Study: Bench testing to demonstrate substantial equivalence.
• Tests Performed: Deployment testing, dimensional testing, tensile strength testing on applicable joints of the delivery system.
• Conclusion: The results indicate that the system performed in a manner substantially equivalent to the predicate devices (LifeStent NT18 and LifeStent NT35 Self-Expanding Biliary Stent Systems).
• Key Argument for Approval: The device has the same intended use, similar materials, similar performance properties, packaging, and sterilization methods as the predicate devices.

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