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Optomed Smartscope M3-1 EY1 digital ophthalmoscope is intended to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye.

Optomed Smartscope M3-1 EY1 is a hand-held digital ophthalmoscope used to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye. M3-1 EY1 has a LED light source. Image data is stored on the Flash memory card using 6.6 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable batteries.

The provided text describes the Optomed Smartscope M3-1 EY1, a digital ophthalmoscope, and its substantial equivalence to predicate devices for regulatory approval (K092056). However, the document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding a ground truth establishment process for image analysis.

The document primarily focuses on establishing substantial equivalence to predicate devices (WELCH ALLYN 11810 Ophthalmoscope and KOWA GENESIS-D hand-held retinal camera) based on:

• Intended Use: Similar capabilities for capturing images/video of eye structures.
• Technological Features: Similar image capture methods, data storage, illumination, user interfaces, etc.
• Non-clinical Performance Data: Optical Equivalency and Radiation Safety measurements described in FDA's Ophthalmoscope Guidance.
• Field of View Comparison: The Optomed device's field of view is stated to be similar to or larger than the predicate Welch Allyn PanOptic Series 118 ophthalmoscope.

Therefore, it is not possible to fill out the requested table and sections as the provided text does not contain the necessary information regarding acceptance criteria, a specific performance study with a test set, ground truth, or details about training sets, MRMC studies, or standalone performance.

The document is a 510(k) summary, which typically focuses on demonstrating equivalence rather than providing detailed clinical study results against specific performance metrics for a novel technology or AI-driven diagnostic device.

If this were a submission for an AI/ML-driven device, the information requested (acceptance criteria, performance metrics, ground truth, study design, etc.) would be crucial. However, for a digital ophthalmoscope seeking equivalence to existing devices, the focus is on safety and effectiveness through technological similarity and adherence to established guidance.

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