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The IRRIS is intended for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices.

The IRRIS is designed for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices. The IRRIS is a non-invasive electronic illumination device. The device transmits light of a specific wavelength (near infra-red) to the underlying tissues. The light enables to illuminate the trachea of the patient, so it can be distinguished from other tissues while using video assisted devices (video-laryngoscopes).

The provided FDA 510(k) summary for the IRRIS (Infra-Red-Red Intubation System) offers some details about its performance evaluation but lacks specific, quantifiable acceptance criteria and a detailed breakdown of the study that proves these criteria are met. However, I can extract and infer information from the provided text to construct an answer based on what is available.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for clinical performance. Instead, it focuses on demonstrating safety, biocompatibility, and functional performance, and ultimately drawing a conclusion of "substantial equivalence." The clinical study's objective was to verify the device aids in ETT placement by illuminating the trachea, not to achieve a specific success rate or performance metric.

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

• Sample Size for Test Set:
  • Clinical Trial: 12 patients.
  • Cadaver Studies (Pre-clinical): 6 cadavers (total from 2 proof of concept studies).
• Data Provenance:
  • Clinical Trial: Conducted "outside of the USA." This indicates international prospective data.
  • Cadaver Studies: Not specified, but likely prospective.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth in either the cadaver studies or the clinical trial. It only states that the clinical trial "verified the device aids in the placement of an ETT" and the cadaver studies "confirmed the acceptability of the device to proceed on humans," implying medical professional assessment.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set or the assessment of "aid in placement" or "illumination."

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

• Was an MRMC study done? No, the document does not mention a multi-reader multi-case comparative effectiveness study. The clinical study was focused on verifying the device's function and safety, not on quantifying improvement with AI (which this device is not) or comparing human reader performance with and without its assistance in a formal MRMC setup.
• Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no such study was conducted or reported. The IRRIS is an "illumination device," not an AI-powered system, and its purpose is to aid, not to replace or directly enhance diagnostic interpretation by humans in a comparative reading setting.

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

• Was a standalone study done? This question is typically relevant for AI/algorithm-based diagnostic devices. The IRRIS is a physical illumination device, not a standalone algorithm. Its function is inherently "human-in-the-loop" as it aids a human performing intubation. Therefore, a "standalone algorithm performance" study is not applicable in the typical sense for this device. Its performance is evaluated in the context of aiding a human procedure.

7. Type of Ground Truth Used

• Clinical Trial: The ground truth for proving the device "aids in the placement of an ETT... by illuminating the trachea" appears to be direct observation and assessment by the medical professionals conducting the intubation procedures. This would likely involve visual confirmation that the trachea was indeed illuminated and distinguishable, and that the ETT was successfully placed. The lack of adverse reactions also contributes to the safety aspect.
• Cadaver Studies: Similar to the clinical trial, the ground truth would be direct observation by medical professionals confirming the "clinical utility and usability" and effectiveness of tracheal illumination.

8. Sample Size for the Training Set

The document describes the IRRIS as an illumination device, not a machine learning or AI-based device that would typically have a "training set." Therefore, there is no mention of a training set or its size. The studies conducted (biocompatibility, electrical safety, software validation, cadaver, clinical) are for verification and validation, not for training a model.

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

As there is no mention of a training set for an algorithm, this question is not applicable.

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