CLARUS

The CLARUS 700 is an advanced ophthalmic camera designed to aid in the diagnosis and monitoring of ocular diseases by capturing high-resolution widefield and ultra-widefield images of the retina, ocular surface, and adnexa. It employs slit-scanning ophthalmoscopy (Broad Line Fundus Imaging) with multiple imaging modes, including true color, autofluorescence, and fluorescein angiography, enhanced by features like automated Optic Nerve Head detection and smart focusing.

The CLARUS 700 is an ophthalmic imaging device designed for capturing, displaying, annotating, and storing images to assist in diagnosing and monitoring diseases of the retina, ocular surface, and visible adnexa. It utilizes imaging modes such as true color, fundus autofluorescence (with green and blue excitation), fluorescein angiography, stereo, and external eye imaging. The device provides widefield (90° single capture) and ultra-widefield (135° montage) views. Its operational principle is slit-scanning ophthalmic imaging, also known as Broad Line Fundus Imaging (BLFI), where a line of illumination scans the retina, and a 2D monochromatic camera captures the reflected light. Different LED illuminations (red, green, blue) are used for various imaging modes, and a deep learning algorithm for Optic Nerve Head (ONH) detection facilitates automated ultra-widefield image montaging. A significant addition to the CLARUS 700 is the Fluorescein Angiography (FA) imaging mode, which aids in visualizing vascular structures of the retina and choroid. This new capability involved hardware modifications from previous models, including new filters, an updated turret and motor, a revised lightbox board, increased system memory (32GB RAM) and storage (2TB HDD), an updated belt-driven slit mechanism, and an improved camera. The accompanying software (version 1.1) introduces automated ONH detection, a 'Smart (Region of Interest) Focus,' auto-brightness for FA image series, and updated EMR connectivity. Clinical testing involving 20 eyes demonstrated the device's efficacy in capturing clinically useful FA images, achieving an 85% success rate for visualizing the area and lesion of interest, and 95% for both clinical image utility and absence of interfering artifacts.

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. How does the deep learning algorithm for Optic Nerve Head (ONH) detection improve the accuracy and efficiency of ultra-widefield montage compared to manual or previous automated methods?; What are the specific advantages and potential limitations of the Broad Line Fundus Imaging (BLFI) technique used in the CLARUS 700 compared to other retinal imaging modalities like confocal scanning laser ophthalmoscopy (cSLO) for fluorescein angiography?; Could the true color imaging capabilities, particularly the separation into red, green, and blue channels, offer quantifiable advantages in diagnosing or monitoring specific retinal pathologies compared to standard color fundus photography?; What is the clinical impact of the 95% passing rate for 'clinically useful image' and 'artifacts do not interfere' in the fluorescein angiography study, particularly in complex cases or subtle pathologies?; How does the 'Smart (Region of Interest) Focus' feature technically operate, and what is its measurable impact on image quality and capture time, especially for patients with focusing difficulties or poor fixation?