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Stenting:

• Esophageal stenoses (strictures), such as stenting refractory benign . strictures and/or malignant strictures (resectable and non-resectable)
• . Stenting esophago-respiratory fistulas
• Maintaining esophagus lumen patency in esophageal strictures caused by . intrinsic or extrinsic tumors

The Polyflex Esophageal Stent System consists of a stent and delivery system. The stent is composed of a polyester braided material encapsulated with silicone. The stent has blue (endoscopic control) and black (fluoroscopic control) markers at both ends and in the center to aid with stent positioning. The delivery system is provided unassembled and consists of the following components:

• Delivery tube. Used to deliver the stent into the esophagus ●
• Stent Loader. With basket for loading the stent into the Delivery tube ●
• Wire Guide with Dilator and stent clamp. For atraumatic introduction of . the Delivery tube into the esophagus using a guidewire
• Graduated Soft Positioner. Flexible aid with inner channel to deploy the . stent from the Delivery tube
• . Stopper. Aid for the temporary fixation of the Polyflex stent during the loading procedure into the Delivery tube.

The provided document (K080332) describes a 510(k) premarket notification for the Polyflex Esophageal Single-Use Stent System. This submission is a request to clarify the existing indication for use of an already marketed device (K030559), specifically by adding "resectable or non-resectable" to the stricture types.

Therefore, this submission does not contain information about new performance testing or studies conducted for this specific 510(k). It explicitly states: "No new materials or design changes were introduced. Therefore, the performance testing presented in 510(k) K030559 was not repeated."

As a result, I cannot provide details on the acceptance criteria and a study that proves the device meets those criteria from this document (K080332). The requested information typically comes from the original submission (K030559) or a new submission involving design changes or new performance claims.

Here's a breakdown of why I cannot answer each point based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available in this document. This 510(k) references the performance testing from K030559, but doesn't reproduce it.
2. Sample sized used for the test set and the data provenance: Not available. This would have been part of the K030559 submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this submission, as no new performance testing was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this submission, as no new performance testing was conducted.
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 document describes a medical device (stent), not an AI-powered diagnostic or decision support system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document describes a medical device (stent), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available. This would have been part of the K030559 submission.
8. The sample size for the training set: Not applicable. This document describes a medical device (stent), not a machine learning model.
9. How the ground truth for the training set was established: Not applicable. This document describes a medical device (stent), not a machine learning model.

In summary, the provided 510(k) (K080332) is a "Special 510(k)" or similar submission to modify an existing indication of a substantially equivalent device, not a de novo submission with new performance data. To find the requested performance data and acceptance criteria, one would need to access the K030559 submission.

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