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The LifeStent NT35 Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

The LifeStent NT35 consist 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 tumor. The flexible, selfexpanding stent is made by laser cutting an open lattice design into a nitinol tube. The subject device is supplied in lengths of 20mm, 30mm, 60mm, 80mm and 90mm and diameters of 9mm and 10mm.

The provided document is a 510(k) Summary for the LifeStent NT35 Biliary Stent System. It details the device, its intended use, and substantial equivalence to a predicate device, but does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document states:

• Performance Data: "Edwards Lifesciences completed bench testing such as deployment testing, dimensional testing, compression force testing, expansion force testing, stent deformation 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 device cited in item 7 above."

This indicates that bench testing was performed to demonstrate substantial equivalence to a predicate device (LifeStent NT18 Self-Expanding Biliary Stent System). However, it does not provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set or their data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Details about a standalone algorithm performance study. (This is a medical device, not an AI/algorithm-driven device, so this type of study is not applicable here.)
7. The type of ground truth used. (Not applicable for a physical device bench test.)
8. Sample size for the training set. (Not applicable for a physical device bench test.)
9. How ground truth for the training set was established. (Not applicable for a physical device bench test.)

In summary, the provided text does not contain the specific information requested regarding acceptance criteria and detailed study results for the LifeStent NT35 to demonstrate meeting those criteria. The submission relies on demonstrating substantial equivalence through bench testing against a predicate device.

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