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The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation.

The Neurovision Ink Printed Endotracheal Tube Electrode is a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation and continuous EMG monitoring of the laryngeal musculature during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use with any compatible EMG monitoring system, for continuous EMG monitoring of the laryngeal musculature as well as providing an open airway for patient ventilation.

The provided 510(k) summary for the Neurovision Ink Printed Endotracheal Tube Electrode primarily focuses on establishing substantial equivalence to a predicate device through technological characteristics and non-clinical testing. It does not describe a study involving acceptance criteria for device performance in a clinical setting, nor does it involve AI, human readers, or ground truth as typically understood in the context of diagnostic or interpretive devices.

Therefore, many of the requested sections regarding acceptance criteria, study details, and expert involvement cannot be extracted from this document, as they are not applicable to the type of submission made.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) does not present a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance. Instead, it demonstrates substantial equivalence through "technological characteristics" and "nonclinical testing."

The document states that the subject device "is substantially equivalent" to the predicate device (NuVasive EMG Endotracheal Tube - K094054). The underlying acceptance criterion for this type of submission is that the new device is as safe and effective as the predicate, based on its similar design, intended use, materials, function, packaging, and sterilization.

The non-clinical tests performed, and their implied "acceptance criteria" through demonstrating substantial equivalence, are:

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

Not applicable. This submission relies on non-clinical testing and comparison to a predicate device, not a test set derived from patient data.

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

Not applicable. Since there's no clinical performance study involving diagnostic interpretation or AI, there was no need for experts to establish ground truth in that context. The "experts" involved would have been the engineers and scientists conducting the non-clinical tests and the regulatory professionals assembling the 510(k).

4. Adjudication Method for the Test Set

Not applicable. No test set involving human judgment or interpretation was used.

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

No, an MRMC comparative effectiveness study was not done. This device is an Endotracheal Tube with EMG monitoring electrodes, not an AI or imaging interpretation device.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only) was not explicitly performed or reported. The device itself is hardware. Its functionality (EMG monitoring) is contingent on a compatible monitoring system (which is not part of this 510(k)). This 510(k) focuses on the safety and technological equivalence of the tube and its electrodes.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established safety and performance parameters for each test (e.g., a minimum force for wire pull, acceptable limits for impedance, passing criteria for biocompatibility assays). For the overall submission, the "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a training set in that context.

9. How Ground Truth for the Training Set Was Established

Not applicable. See point 8.

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