(56 days)
Eusol-C is indicated when it is desired to store explanted corneas for up to 14 days. It is intended for use by physicians or highly skilled personnel, such as Eye Bank operators.
Not Found
The provided text is related to a 510(k) premarket notification for a medical device called "Eusol-C" which is intended for storing explanted corneas. However, the document does not contain any information regarding acceptance criteria, device performance, study details (sample size, provenance, expert details, adjudication methods), or training set information.
The document is primarily an FDA clearance letter and an "Indications for Use" statement. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements.
Therefore, I cannot provide the requested information based on the given text.
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