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The NeuroVision EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

The NeuroVision® EMG Endotracheal (ET) Tube is a low pressure cuff endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery.

The provided text is a 510(k) summary for the NuVasive® NeuroVision® EMG Endotracheal Tube. It primarily focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use.

Crucially, this document does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria through performance metrics like sensitivity, specificity, or accuracy. Instead, the substantial equivalence argument relies on comparing the device's characteristics to already-cleared devices.

Therefore, most of the requested information cannot be extracted from this document. However, I can provide what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria (e.g., performance thresholds) are explicitly stated in this document.
• No quantitative device performance metrics (e.g., sensitivity, specificity, accuracy) are reported.
• The document states that "Engineering specifications and labeling have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device." This describes the basis for equivalence rather than performance against defined criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable. This document describes a 510(k) submission based on substantial equivalence, not a clinical study with a test set of data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. Ground truth establishment by experts for a test set is not described.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This document does not mention any MRMC comparative effectiveness study comparing AI assistance with human readers. The device itself is an endotracheal tube with EMG monitoring capabilities, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable. The device is a physical endotracheal tube with integrated electrodes; it is not an algorithm or AI system for which standalone performance would be assessed in this context.

7. Type of Ground Truth Used:

• Not applicable. Ground truth for a performance study is not described. The "ground truth" in this context is the understanding of the predicate devices' safety and effectiveness, which is assumed.

8. Sample Size for the Training Set:

• Not applicable. No training set for an algorithm is described.

9. How Ground Truth for the Training Set Was Established:

• Not applicable. No training set or ground truth establishment for it is described.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence through a comparison of device characteristics and intended use with predicate devices, rather than through a study proving performance against defined acceptance criteria.

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