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Optomed Smartscope M5 camera with optics modules EY3 and ES1 is a digital ophthalmoscope intended to capture digital images and video of the fundus of the human eye and surrounding area.

Optomed Smartscope M5 is a hand-held digital ophthalmoscope that together with the optics modules EY3 and ES1 is used to capture digital images and video of fundus and surrounding area of the human eye. M5 EY3 has an LED light source with visible white light and infrared light. M5 ES1 has an LED light source with white light and cobalt blue light. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable batteries.

The provided text describes a 510(k) summary for the Optomed Smartscope M5 ophthalmoscope and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., performance metrics, sample sizes, expert adjudication, etc.).

The document focuses on demonstrating substantial equivalence to predicate devices. It discusses:

• Device description and intended use: Capturing digital images and video of the fundus and surrounding area of the human eye.
• Comparison to predicate devices: Highlighting similar indications for use and technological features like digital image capture, storage, connectivity, illumination, and method of operation.
• Improvements over predicate devices: Such as infrared light for targeting, autofocus, improved image quality due to a new sensor and increased pixel resolution, and better connectivity to newer operating systems.
• Safety information: Specifically, optical radiation hazards as defined by the ISO 15004-2 standard.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the provided text.

The document states that "Technical Information was gathered by side-by-side comparison and labeling of the devices. Optomed Smartscope M5 with optics modules EY3 and its predicates were also evaluated by Optomed development team and practicing physicians throughout the product development. Outcome of the evaluation is that ease-of-use and effectiveness of the Optomed Smartscope M5 with optics modules EY3 and ES1 is equivalent or better as its predicates." This implies some form of qualitative assessment, but it does not detail a structured study with quantifiable acceptance criteria or the specific elements you requested.

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