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The Yeescope laryngoscope is a single use, disposable laryngoscope blade and handle that is intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Yeescope laryngoscope blades and handles are single use, fully disposable laryngoscopes identical to our standard units except we have exchanged the battery to one that is less magnetic and thus would meet the requirements for MR conditional environments.

Yeescope laryngoscope are offered in one (1) style and two (2) sizes; Macintosh style (curved) and in Sizes 3 and 4.

The Yeescope Laryngoscope is a single use, disposable laryngoscope blade and handle intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment up to a 3.0 Tesla static magnetic field.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document specifies "Mac 4" and "Mac 3" without detailing the exact number of units tested for each size. However, it implies at least one of each size was tested to obtain the reported deflection values.
• Data Provenance: The testing was performed according to ASTM F2052-02, a standard test method. The country of origin of the data is not explicitly stated, but the manufacturer is based in Australia. It is a prospective test, as the document describes the testing performed on the device itself.

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

This information is not applicable to this submission. The ground truth for this device is based on objective, quantifiable physical properties (magnetic deflection) as measured by a standardized test method (ASTM F2052-02), not on expert subjective opinion or interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The test involves direct physical measurement of magnetic deflection, which does not require adjudication.

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

Not applicable. This device is a physical medical instrument, not an AI or imaging diagnostic tool that would involve human readers interpreting output.

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

Not applicable. This device is not an algorithm or AI system. Its performance criteria are based on its physical properties in an MR environment.

7. Type of Ground Truth Used:

The ground truth used is a standardized physical test method (ASTM F2052-02) that objectively measures the magnetic field displacement force on medical devices. The pass criteria for this test (deflection < 45 degrees) serves as the defined ground truth for magnetic compatibility in an MR environment.

8. Sample Size for the Training Set:

Not applicable. There is no training set for this device as it is not an AI/ML product.

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

Not applicable. There is no training set.

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