VISIONAIR

The VISIONAIR™ system is a software application intended for use with third-party endoscopes to measure the nasal respiratory airway, specifically the internal nasal valve and nasal cavum. It utilizes an AI-driven algorithm to automatically analyze and segment endoscopic images, which are based on light reflection, to provide quantitative cross-sectional area measurements of these anatomical structures.

The VISIONAIR™ system is a software application designed to measure the nasal respiratory airway by analyzing images obtained from third-party endoscopic systems. Its primary function is to quantify the cross-sectional area of the internal nasal valve (INV) and nasal cavum (NC). The system architecture includes the VISIONAIR™ AI algorithm for automated segmentation, a graphical user interface (GUI) for data interaction, a smart device (Windows 10 or later tablet/laptop) to run the application, an optional cloud service (REAl) for secure and anonymous data storage, and a USB memory key. This USB key is crucial for encrypting and anonymizing patient information, storing decryption keys, and holding credits necessary to activate the software for each case. The application interfaces with endoscopes via standard ports on the smart device, allowing video streaming and image capture for analysis. The scientific principle behind VISIONAIR™ involves its AI algorithm analyzing endoscopic images, which are generated through light reflection mapping the nasal passage's topography. The algorithm is trained to identify and segment the INV and NC to determine their surface areas, providing quantitative data for assessing the nasal airway. Patient information (name, DOB, optional ethnicity for normative data comparison) is encrypted before being stored either locally on the smart device or on the cloud. Non-clinical performance testing was conducted to validate the system's design specifications, covering system-level functionality, interface and connectivity, application performance, patient database encryption and verification, endoscopic display quality, AI-driven nasal airway analysis accuracy (including comparisons against CT scans and clinician segmentations), report generation, and overall user validation.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What were the specific quantitative results of the 'CT vs Segmentation Accuracy Test' and the 'VISIONAIR™ AI Segmentation Accuracy Test' compared to experienced clinicians?; How does the VISIONAIR™ system account for potential variabilities in image quality (e.g., lighting, angle, secretions) from different third-party endoscopic systems when performing AI-driven measurements?; What is the range of third-party endoscopic systems validated for use with the VISIONAIR™ application, and are there specific compatibility requirements or limitations?; How does the system's reliance on credits via a USB TOKEN for image analysis impact workflow in a busy clinical setting, and what is the cost structure for these credits?; What normative dataset is used for comparing patient measurements, and how was this dataset established and validated for diverse patient populations, including different ethnicities?