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Hypothermic (2-8°C) human corneal storage for 14 days

Cornea Cold® is a sterile hypothermic corneal storage medium intended for human corneal storage at 2-8°C, for up to 14 days. Corneas are directly placed in Cornea Cold storage medium after surgery, and stored in eye banks between +2°C for a maximum of 2 weeks. The shortest storage time is determined by the time needed to obtain serology results of the donor. It is for single use, to be used by physicians or highly skilled personnel such as bank operators. The device gets into direct contact with the patient by accumulation in the cornea graft.

The provided text describes the 510(k) submission for the Cornea Cold® device, a hypothermic corneal storage medium. The submission asserts substantial equivalence to a predicate device, Optisol-GS. However, the document does not contain specific acceptance criteria, detailed study results, or the other requested information for algorithm performance.

The document is a regulatory submission for a medical device that preserves biological material (corneas), not an AI/ML algorithm that analyzes data to produce performance metrics like sensitivity, specificity, or AUC. Therefore, a direct answer to the prompt's request for acceptance criteria and studies proving an algorithm's performance cannot be provided from this document.

The "Performance" section within the table comparing the device to the predicate device simply states "Substantially equivalent to predicate device." This indicates that the performance was deemed similar enough to the legally marketed predicate device to establish substantial equivalence, without providing specific metrics or a detailed study report.

In summary, the provided document does not contain the information required to answer the prompt regarding acceptance criteria and performance studies of a device that uses an algorithm. It describes a medical device in the context of its regulatory clearance rather than its analytical or diagnostic performance metrics.

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