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The Rüsch Edgar Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management. The integral instillation system is indicated for drug instillation by the endobronchial route, anesthetic administration and gas monitoring.

The Rüsch Edgar Tube will be offered in the Magill pattern in two (2) versions - cuffed and uncuffed. Cuffed versions will have a low-pressure/high volume cuff, inflated via a luer activated valve. A pilot balloon will be provided to give a visual indication of cuff status.

The Rüsch Edgar Tube consists of a clear endotracheal tube with a radiopaque stripe. The main tube is graduated with multiple centimeter markings to facilitate determination of intubated length. The instillation lumen is connected to a luer lock connector with cap by a tube that is color coded to prevent confusion with the cuff inflation line.

The Rüsch Edgar Tube will be available in a variety of sizes ranging from 2.5mm - 6.0mm uncuffed and 6.5mm - 10.0mm cuffed. Both versions will be available in 0.5mm increments.

The provided text is a 510(k) premarket notification summary for the Rüsch EDGAR Tube. This document establishes substantial equivalence to previously marketed devices, rather than presenting a study proving a device meets specific acceptance criteria for performance.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), training set details, and ground truth establishment cannot be extracted from this document, as such a study was not conducted or reported for this type of device submission.

The 510(k) process is primarily a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and intended use, and not through performance studies with acceptance criteria in the way you've outlined for novel AI/medical device performance.

Here's what can be extracted from the document:

• Device Name: Rüsch EDGAR Tube
• Intended Use: "The Rüsch Edgar Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management. The integral instillation system is indicated for drug instillation by the endobronchial route, anesthetic administration and gas monitoring."
• Predicate Devices:
  • Rüsch Safety Tracheal Tubes - Preamendment
  • Rüsch AGT PVC Preformed Nasal Tracheal Tubes - K931163/K931166
  • Rüsch Oral/Nasal (Safety Clear Plus™) Tracheal Tube, Cuffed, Magill/Murphy, Sterile - K993786
  • The Hudson RCI Sheridan ETCO2 Uncuffed Tubes K861454
  • The Hudson RCI Sheridan LITA Cuffed Tracheal Tubes - K834463
  • The Mallinckrodt Emergency Medical Tube (EMT) 510(k) # Unknown

Conclusion:

The provided document does not contain the information necessary to fill out your requested table and study details because it describes a 510(k) submission based on substantial equivalence, not a performance study against predefined acceptance criteria for a novel medical device like an AI algorithm.

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