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The Eye Cup Sterile I 's and the Eye Cup Non Sterile are each a cup that holds liquids, such as eye wash solution, used to flush out the eye.

a) Eye Cup Sterile 1's b) Eye Cup Non Sterile

The provided text is a 510(k) premarket notification letter from the FDA for an "Eye Cup Sterile 1's and Eye Cup Non Sterile" device. This document does not contain information typically found in a study or a description of acceptance criteria for an AI/CADe (Computer-Aided Detection) device.

The letter explicitly states that the device is an "Eye Cup" used to "flush out the eye." It pertains to a physical medical device, not a software algorithm. Therefore, the requested information about acceptance criteria for an AI device, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not applicable and cannot be extracted from this document.

The letter is a regulatory approval, confirming that the device is substantially equivalent to legally marketed predicate devices, and outlines general regulatory compliance. It does not include any performance data or study details for the device itself.

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