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The MR Fiber Optic Intubating Laryngoscope Handle, Standard ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard") is used to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

The MR Fiber Optic Intubating Laryngoscope Handle, Standard

This document is a 510(k) summary for a medical device called the "MINRAD INC.'s MR Fiber Optic Intubating Laryngoscope Handle, Standard." It outlines the device's information, intended use, and substantial equivalence to predicate devices, leading to its clearance by the FDA in 2006.

1. Table of acceptance criteria and the reported device performance

This document does not list specific acceptance criteria related to quantifiable performance metrics (e.g., accuracy, precision, sensitivity, specificity) or any reported device performance data in that context. The clearance is based on substantial equivalence, implying the device performs similarly to predicate devices without needing a new clinical performance study for this specific 510(k). The primary "acceptance criteria" for this submission are related to its similarity in technological characteristics and intended use to existing, legally marketed devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This 510(k) summary does not describe a clinical study with a test set in the traditional sense of evaluating performance metrics like sensitivity or specificity. The submission is based on demonstrating substantial equivalence to predicate devices, not on original clinical performance data for the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As noted above, there is no mention of a test set with ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical instrument (a laryngoscope handle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is described as having been established for this submission.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would require a training set.

9. How the ground truth for the training set was established

Not applicable. No training set or ground truth for it is relevant to this device submission.

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