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Airtraq® SP - MR and Airtraq® Avant are intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Airtraq® Optical laryngoscope is an anatomical shaped rigid laryngoscope which allows the user to see the airway anatomy during insertion and intubation. It is designed with a guide channel in which one loads the endotracheal tube ("ET tube") that is then advanced once the glottis opening has been identified and centered in the view field of the Airtraq® optics. Prodol Meditec offers two (2) models.

Airtraq® SP - single patient
This model is a completely self-contained unit that operates on standard non-magnetic AAA batteries. It is a single patient use, disposable.

Airtraq® Avant
Avant once assembled is identical in its design and function as the Airtraq@ SP model.
Avant is designed as 2 components unlike the Airtraq® SP model.

1. Optics This is a limited life reusable components which contains the lenses and mirrors of the optical system plus the rechargeable, non-magnetic battery, and PCB which controls the LED light, heater and diagnostics for the battery.
2. Blade There are 2 blade sizes, Regular (ET tube size 7.0 mm to 8.5 mm) and Small (ET tube 6.0 mm to 7.5 mm). These are single use disposables in which the Optics are inserted and then the assembled device used. There is an eye cap that incorporates a protective lens that fits over the Optics once it has been inserted into the Blade.

Acceptance Criteria and Study for Airtraq® MR and Airtraq® Avant

This summary details the acceptance criteria a medical device needs to meet and the study conducted to prove it, based on the provided 510(k) Premarket Notification.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Airtraq® MR and Airtraq® Avant devices, as described in the provided document, primarily relate to their magnetic resonance (MR) compatibility.

Note: The document explicitly states that the "Pass criteria is deflection of < 45 degrees" for the ASTM F2052-02 test. For the proposed device, it states "Testing has been performed according to ASTM F2052-02 for deflection in a 3.0 Tesla environment," and the device is deemed substantially equivalent, which implies successful adherence to this pass criterion.

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

• Sample Size: The document does not specify a distinct "test set" sample size in terms of a patient cohort or a number of device units tested. The performance testing refers to the ASTM F2052-02 standard, which is a laboratory-based physical test on the device itself.
• Data Provenance: The testing is laboratory-based performance testing of the device's physical properties in a simulated MR environment. It is not patient data from a specific country or collected retrospectively/prospectively.

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

This section is not applicable to the provided information. The ground truth for this device's acceptance criteria is based on a standardized physical test (ASTM F2052-02) for magnetic compatibility, not on expert consensus from clinical evaluation or image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable to the provided information. The performance testing is a standardized physical measurement, not a clinical study requiring expert adjudication of results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

A MRMC comparative effectiveness study was not conducted or described. The document focuses on demonstrating the device's physical compatibility with an MR environment, not its clinical effectiveness compared to unassisted human readers or other devices in a reader-based study.

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

This section is not applicable. The device is an optical laryngoscope, a physical medical instrument, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for the acceptance criterion is defined by the standardized measurement of physical deflection of the device when exposed to a 3.0 Tesla static magnetic field, as stipulated by the ASTM F2052-02 standard. It is a direct physical measurement against a quantitatively defined threshold.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical instrument, not an AI or machine learning model that requires a "training set."

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

This section is not applicable for the reasons stated in section 8.

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