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The E>Eye is a prescription device intended for the treatment of rosacea.

The E>Eye C is an intense pulsed light system composed of a base housing the electric and electronics sub-assemblies, and a handheld piece "applicator" connected to the base by a cord. The applicator contains the source of optical radiation.

The provided document describes the 510(k) premarket notification for the E>Eye C device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, the performance data presented is entirely focused on non-clinical testing related to device safety, usability, and software validation. There is an explicit statement: "Clinical Data: None."

Therefore, I cannot provide the requested information regarding acceptance criteria for diagnostic performance or a study demonstrating the device meets such criteria because this information is not present in the provided text.

Specifically, the document states:

• "Clinical Data: None." (Page 6)
• "The E>EYE C was found to perform as well as its predicate, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues." (Page 6)

This indicates that substantial equivalence was primarily established based on technological characteristics and non-clinical safety data, rather than a clinical study evaluating diagnostic performance against predefined acceptance criteria.

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