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The NuVasive 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 NuVasive® EMG Endotracheal (ET) Tube is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The EMG ET Tube is provided as a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation during EMG neuromonitoring of the Recurrent Laryngeal Nerve (RLN).

Here's a breakdown of the acceptance criteria and study information for the NuVasive® EMG Endotracheal Tube, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each nonclinical test (biocompatibility, functional bench testing, stability, sterilization & packaging). It generally states that "Nonclinical testing was performed."

The data provenance is from nonclinical laboratory testing conducted by the manufacturer, NuVasive, Incorporated. It is not patient or human subject data, so concepts like "country of origin" for data are not applicable in this context, nor is it a retrospective or prospective study on patient outcomes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For nonclinical tests like biocompatibility and functional bench testing, ground truth is typically established through adherence to recognized standards (e.g., ISO 10993, ISO 5361) and internal quality control specifications, rather than through expert consensus in the way clinical diagnostic studies might.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of these nonclinical tests (objective measurements against established standards), formal adjudication methods like 2+1 or 3+1 by human experts are generally not used. The results are typically interpreted against quantitative criteria defined by the test protocols and standards.

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

No, an MRMC comparative effectiveness study was not done. This study is focused on the substantial equivalence of a medical device (an EMG Endotracheal Tube) based on nonclinical performance data, not on the comparative effectiveness of human readers with or without AI assistance in interpreting medical images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This device is a passive accessory (an endotracheal tube with electrodes) that connects to a separate EMG monitor. It is not an algorithm or an AI-powered system that would have a "standalone" performance without human interaction (e.g., a surgeon using it for monitoring). The document explicitly states, "This device does not contain software."

7. Type of Ground Truth Used

The ground truth used for these nonclinical tests is based on:

• Established international standards and guidelines: Such as ISO 10993-1 for biocompatibility and ISO 5361 for functional testing.
• Manufacturer's internal specifications and criteria: Derived from engineering design and performance requirements.
• Objective measurements and observations: Against predefined pass/fail criteria for each test.

8. Sample Size for the Training Set

There is no training set for this device. This is a physical medical device, not an AI/ML algorithm that requires training data.

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

Not Applicable. As there is no training set for this physical device, there is no ground truth to establish for a training set.

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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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