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MiiS Horus Scope DEC 100 is a digital hand-held eye-fundus camera used to record digital photographs and video of the fundus of the human eye and surrounding area.

MilS Horus Scope DEC 100 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area. It is more efficient and suitable for many different applications, such as telemedicine and electronic filing.

The provided text is a 510(k) summary for the MiiS Horus Scope DEC 100, a digital hand-held eye-fundus camera. This document focuses on establishing substantial equivalence to a predicate device and includes the device description, intended use, and a formal letter of clearance from the FDA.

Crucially, the document does not contain any acceptance criteria or details of a study proving the device meets acceptance criteria. It is a regulatory submission for market clearance, not a clinical study report. Therefore, I cannot provide the requested information.

The document states:

• "MiiS Horus Scope DEC 100 is substantially equivalent to the predicate device with respect to functionality, design verification, intended use and performance characteristics."
• "Based on the 510(k) summaries and the information provided herein, we conclude that the submitted device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act."

This indicates that the submission focuses on demonstrating equivalence rather than presenting specific quantitative performance metrics against predefined acceptance criteria from a clinical study.

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