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Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central ridence obsphagetee trachea and main bronchus), and arrways (Such as trictures due to tumors (Trachea and main bronchus) .

Compression or strictures due to tumors (trachea and main bronchus) Stenosis of the central airways (such as trachea and main bronchus) Tracheo Esophageal fistula

Airway complications such as-anastomosis and stenosis

The Rusch Polyflex Stent Kit consists of a medical silicone file Rusch folyrica beene core along with the components Suppored by insert the device into the human body. These required to inocre one he Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper.

This amendment changes the material of the Insertion ffirs amending to adds indicator markings to the stent and provides for a non-sterile version.

The provided text is a 510(k) summary for the Rusch Polyflex Stent Kit. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study demonstrating that the device meets specific acceptance criteria through clinical trials and data analysis.

Therefore, the input does not contain information about:

• Acceptance criteria in the context of a clinical performance study.
• A study proving the device meets acceptance criteria.
• Reported device performance against acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth was established.

The prompt asks for details that are typically found in clinical evaluation reports or performance studies, which are not present in this 510(k) summary. A 510(k) is primarily focused on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety/effectiveness based on comparison to existing predicate devices, rather than presenting a detailed clinical performance study with acceptance criteria.

Therefore, it is impossible to extract the requested information from the provided text.

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Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central airways(such as the trachea and main bronchus), and Compression or strictures due to tumors (Trachea and main bronchus) .

The Rüsch Polyflex Stent Kit consists of a medical silicone supported by a polyester core along with the components required to insert the device into the human body. These components consist of the Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper.

This document is a 510(k) summary for the Rusch Polyflex Stent Kit. It details the device's description, intended use, and claims of substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) process is a premarket notification to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (predicate device). It typically does not involve new clinical studies to establish acceptance criteria or device performance against those criteria in the way a PMA submission might.

Therefore, I cannot provide the requested information from the given text.

If this were a PMA or a different type of submission that included performance data, I would look for sections detailing:

• Acceptance Criteria: Often expressed as performance targets (e.g., sensitivity, specificity, accuracy, or specific clinical outcomes).
• Study Design: Information on clinical trials, their methodology, endpoints, and statistical analysis.
• Results: The reported performance of the device against the defined criteria.

Since this information is not present in the provided 510(k) summary, I can only state that it is not available here.

Ask a specific question about this device