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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 status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

The Neurovision Ink Printed Endotracheal Tube Electrode is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring 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 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 Laryngel Nerve (RLN).

The provided 510(k) summary for K130806, the Neurovision Ink Printed Endotracheal Tube Electrode, does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner typically expected for AI/ML devices. This submission for the Neurovision Ink Printed Endotracheal Tube Electrode is a Special 510(k), which is used for modifications to a legally marketed device where the modification does not affect the device's fundamental scientific technology. In such cases, the primary focus is on demonstrating that the modified device remains substantially equivalent to the predicate device and that the modifications do not introduce new questions of safety or effectiveness.

The document states that nonclinical testing was performed to demonstrate substantial equivalence. These tests focused on the functional and material characteristics of the modified device in comparison to the predicate device.

Here's an analysis of the provided information, focusing on aspects that might loosely correspond to "acceptance criteria" and "study results" in the context of this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document does not explicitly list "acceptance criteria" with quantitative targets as one might find for a new AI/ML device. Instead, it focuses on demonstrating equivalence to the predicate device through various non-clinical tests.)

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

• Test Set Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical cases. The tests described (valve functionality, electrode impedance, bend tests, biocompatibility) are non-clinical, bench-top tests performed on device samples. The specific number of device units tested for each non-clinical test is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data for this submission. The tests are non-clinical (bench testing and biocompatibility).

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

• Not applicable. The ground truth for the non-clinical tests (e.g., whether a valve functions, impedance values, bend resistance, biocompatibility) is established through standardized testing protocols and measurements, not expert human interpretation of clinical data or images.

4. Adjudication Method for the Test Set

• Not applicable. There is no human adjudication for non-clinical, objective measurements like impedance or bend tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is not an AI/ML diagnostic or assistive technology for human readers. It is a medical device for EMG monitoring.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the non-clinical tests is based on objective, quantifiable measurements against established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and functional equivalence to the legally marketed predicate device.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" described in the 510(k) summary is a collection of nonclinical tests designed to demonstrate that the modified Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to its predicate device (K110989 Neurovision Ink Printed Endotracheal Tube Electrode) and that the modification (change in reinforcing material's attachment adhesive) does not alter the fundamental safety or effectiveness.

The document states:
"Nonclinical testing, including valve functionality, electrode impedance and bend tests demonstrated that the subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicate."

Additionally, biocompatibility testing was performed following ISO standards:
"Biocompatibility testing included ISO 10993-11 Systemic Toxicity, ISO 10993-10 Intracutaneous Sensitivity and ISO 10993-10 Irritation and Skin Sensitization."

These tests, by demonstrating equivalence in critical functional aspects and meeting safety standards for biological interaction, serve as the evidence that the modified device "meets acceptance criteria" in the context of a Special 510(k) submission. The inherent acceptance criteria for such a submission are successful completion of these tests, confirming that the device performs functionally the same as the predicate and is safe for its intended use, despite the minor material modification.

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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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