(168 days)
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
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ||
| Cytotoxicity testing – MEM Elution | Non-cytotoxic | Discrete intracytoplasmic granules; no cell lysis (Grade 0) - Pass (Non-cytotoxic) |
| Intracutaneous testing – NS and CSO | No erythema (Score 0) & No edema (Score 0) | No erythema (Score 0) & No edema (Score 0) - Pass (Requirements met) |
| Sensitization testing – NS and CSO | No sensitization observed (Score 0) | No sensitization observed (Score 0) - Pass (Non-sensitizer) |
| Systemic toxicity – NS and CSO | No signs or symptoms of systemic toxicity observed | No signs or symptoms of systemic toxicity observed - Pass (Requirements met) |
| Functional Bench Testing | ||
| Functional testing per ISO 5361 | Meets specifications of ISO 5361 | Meets specifications and criteria |
| Inflation valve functionality | Functional | Meets specifications and criteria |
| Leak test | No leaks | Meets specifications and criteria |
| Electrode resistance test | Appropriate resistance levels | Meets specifications and criteria |
| System integration test | Compatible with EMG monitor | Meets specifications and criteria |
| Bending test | Maintains integrity and function after bending | Meets specifications and criteria |
| Other Testing | ||
| Stability Testing | Maintains performance over time | Meets specifications and criteria |
| Sterilization & Packaging Validations | Sterile/maintains sterility & packaging integrity | Meets specifications and criteria |
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.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.