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MiiS Horus Eye Anterior Camera is a digital hand-held slit lamp system indicated for non- invasive illumination, magnification, visualization and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area.

MiiS Horus Eye Anterior Camera is a digital hand-held slit lamp system indicated for non-invasive illumination, magnification, visualize and to record digital photographs and video of anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. It is a Li-ion battery-powered optical device. It brings more complete medical records about the static photos as well as the dynamic videos. MiiS Horus Eye Anterior Camera has an LED light source with visible white light. The device is designed with high-resolution lens and 5M pixels CMOS Sensor, faithful rendering color of the anterior segment (including cornea, anterior chamber, and lens) of the human eye and surrounding area. The device can store pictures or videos in memory card, or via the USB, Wi-Fi and Bluetooth transfer pictures or videos to a computer. In addition to rendering images in the 3.5-inch full color TFT-LCD, through the HDMI output, you can connect the device to the big screen (TV, LCD screen) showing the pictures or videos.

MiiS Horus Eye Anterior Camera includes two models. The first model consists of control unit DSC 300 and lens unit DEA 200. The second model consists of control unit DSC 300P and lens unit DEA 200P. Either auto or manual focus can be used in first model while only manual focus is used in the second model.

The control unit DSC 300 includes a cover glass while DSC 300P does not. The contact rim in lens unit DEA 200 is different from that in DEA 200P.

This document does not include information about AI/ML features, acceptance criteria, or ground truth establishment. The device described, MiiS Horus Eye Anterior Camera, is a digital hand-held slit lamp system. It is a traditional medical device for visualization and recording of the anterior segment of the eye, not an AI/ML-powered diagnostic tool.

Therefore, I cannot provide details on acceptance criteria for AI/ML performance, study designs involving AI assistance, or related ground truth methodologies, as these are not relevant to the information provided in the input text.

The closest relevant sections in the provided text are regarding nonclinical tests and optical radiation safety assessment. These sections outline tests performed to ensure the device's safety and functionality in a traditional sense, not related to AI/ML performance metrics.

Specifically, the document states:

• Nonclinical Tests: "The following tests have been performed in support of the substantial equivalence determination: IEC 62304 for Software verification and validation testing. - IEC/EN 60601-1:2005/2006+A1:2012/2013 for electrical safety. - IEC/EN 60601-1-2:2014/2015 for electromagnetic compatibility. - Bluetooth testing for compatibility and functionality. - HDMI compliance test was conducted in compliance with HDMI 1.4b sink and source devices. - ISO 14971:2007 and EN ISO 14971:2012 for risk management. - -ISO 15004-2:2007 for light hazards. ISO10993-5:2009 and ISO10993-10:2010 standards for biocompatibility. The patient contacting parts are the holder of chin rest CR100 and the forehead stopper."
• Clinical Tests: "No clinical studies were performed."
• Optical Radiation Safety Assessment: "The MiiS Horus Eye Anterior Camera was tested according to 15004-2:2007 to determine acceptable light safety limits for both the illumination and background lights. The test results demonstrate the MiiS Horus Eye Anterior Camera is in compliance with the of Group 2 instrument requirements provided by the standard."

These tests confirm the device's compliance with safety and performance standards for a medical imaging device, but not for an AI/ML algorithm's diagnostic accuracy or performance.

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