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The NovaMed MRI Conditional laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

The NovaMed MRI Conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.

The NovaMed MRI Conditional Laryngoscope set was evaluated for safety in a Magnetic Resonance (MR) environment up to 3.0 Tesla. The primary study was to determine the device's magnetic attraction in this environment.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify the exact sample size used for the test set of laryngoscope components. It states "many handle and blade configurations offered" were tested.

The data provenance is not explicitly stated as retrospective or prospective, nor the country of origin. However, the study involves testing the physical device in a lab setting rather than clinical patient data. The standard used, ASTM F2052-02, is an American Society for Testing and Materials standard.

3. Number and Qualifications of Experts for Ground Truth

This information is not provided. The ground truth for this type of test (magnetic attraction) is objectively measured based on physical properties and adherence to the ASTM standard, rather than expert consensus on medical image interpretation.

4. Adjudication Method

This information is not applicable for this type of physical device testing. The results of the magnetic attraction test against the ASTM standard are objective measurements, not subject to adjudication by experts.

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

No. An MRMC comparative effectiveness study was not conducted. This device is a physical instrument, and its performance regarding magnetic safety is determined by objective physical testing, not by human reader interpretation of images. The device facilitates a medical procedure; it is not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical instrument, not an algorithm or software. Its performance is inherent to its material properties and design.

7. Type of Ground Truth Used

The ground truth used is based on objective physical measurements related to magnetic attraction as defined by the ASTM F2052-02 standard. This standard specifies a method for measuring the magnetic attraction of medical devices in an MR environment.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI model requiring a training set.

9. How Ground Truth for the Training Set was Established

Not applicable, as there is no training set for a physical medical instrument.

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