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The Rusch TracheoFix-Set (TFS) is a single patient disposable tracheostomy Tube for airway management of tracheostomized patients.

The TracheoFix-Set consists of the following:

• . outer tube with low pressure cuff and pilot balloon, flexible fixation flange and turn lock fastener (the flange is not adjustable).
• luer activated valve for cuff inflation/deflation .
• luer activated valve for carr inituseem.
  Inner tube with standard taper and a replacement inner . tube
• introducer .
• standard connector .
• neck band .
  · neck band
  The Rusch TracheoFix-Set is a sterile, single patient, The Rusch fracheorin , pressure tracheostomy tube.

The provided text is a 510(k) summary for the Rusch TracheoFix-Set, a tracheostomy tube. It describes the device, its intended use, and claims substantial equivalence to existing predicate devices.

Crucially, this document focuses on regulatory equivalence and does NOT contain information about specific acceptance criteria, performance studies, or clinical trial data on the device itself. It is a regulatory submission, not a scientific publication detailing performance metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided text does not contain this information.

The document only states that the device is "substantially equivalent in design, use, and materials" to predicate devices and that its "technological characteristics are the same as or equivalent to predicate devices." This substantial equivalence claim is the basis for its clearance, not a demonstration of specific performance against acceptance criteria in a clinical study.

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