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Stenting: Esophaqeal stenoses (strictures), such as stenting refractory beniqn strictures and/or malignant strictures Esophageal-respiratory-fistula Maintaining esophagus lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors

The Rüsch Polyflex Stent for the Esophagus with Introducer System consists of the Polyflex Stent, Introducer Sleeve, Stent Loader, Insertion Tube with Dilator, Soft Positioner, Stopper and Stent Clamp.

This document is a 510(k) Summary for a medical device called the "Rüsch Polyflex Stent for the Esophagus with Introducer/Delivery System." It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not include information about acceptance criteria or a study proving the device meets acceptance criteria as this type of information is typically found in a clinical study report, not a 510(k) summary for a Class II device.

Therefore, I cannot provide the requested information based on the provided text.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or its data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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