Search Results

The Tru-MR TM 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 Truphatek Tru-MRTM MR 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.

Here's a breakdown of the acceptance criteria and the study details for the Truphatek Tru-MR™ Laryngoscope set, based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes physical testing of the device for MR compatibility, not a study involving human or clinical data. Therefore, the concept of "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" as it refers to patient data is not applicable.

The "test set" for this device was the Truphatek Tru-MR™ Laryngoscope set itself (handle, battery, and blades). The testing was performed on the device to verify its MR Conditional properties.

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

This type of information is not applicable to this submission. The "ground truth" for MR compatibility of a medical device is established by standardized testing protocols (e.g., ASTM F2052-02), not through expert consensus or interpretation of clinical data in the same way an AI algorithm's output might be evaluated. The result (e.g., < 45 degree string deflection) is a direct, measurable physical outcome.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert opinions on clinical data are resolved. For physical device testing, the results are objectively measured according to the specified standard.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI systems in a clinical setting, often comparing human readers with and without AI assistance. The Truphatek Tru-MR™ is a physical medical device (laryngoscope) and not an AI system.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not done. This is not an AI-powered device. The "performance" described is the physical device's MR compatibility.

7. Type of Ground Truth Used

The "ground truth" used for this device was based on physical measurements and adherence to an industry standard: ASTM F2052-02. The acceptance criterion of "< 45 degree string deflection" in a 3.0 Tesla environment serves as the objective measure of its MR compatibility, which is the key performance aspect for this device's intended use.

8. Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

Ask a specific question about this device