(110 days)
CORNISOL is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C).
Cornisol is a sterile hypothermic corneal storage medium intended for human corneal storage between 2 and 8℃ for up to 14 days. Cornisol is for single use and to be used only by physicians or highly skilled personnel such as eye bank operators. Corneas are directly placed in Cornisol medium after surgery with a storage time based on the time needed to obtain serology results of the donor but for a period of time of no more than 14 days.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
The provided document is a 510(k) summary for a medical device called "Cornisol," a corneal storage solution. It discusses the device's characteristics, intended use, and comparison to a predicate device (Optisol-GS) to demonstrate substantial equivalence.
However, the document does not provide specific acceptance criteria or detailed results of a comparative effectiveness study with human readers. It focuses on the chemical, physical, and in-vitro performance of the solution itself, rather than an AI-assisted diagnostic device.
Therefore, many of your requested items, such as multi-reader multi-case studies, AI assistance, ground truth establishment for training/test sets, and sample sizes for AI model training/testing, are not applicable to this type of device (a corneal storage solution). The performance evaluation here is about the preservation efficacy of the solution, not the diagnostic accuracy of an AI algorithm.
Here's what can be extracted and inferred based on the provided text, and where information is missing:
Device Under Review: Cornisol (Corneal Storage Solution)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the in-vitro study results. The key performance characteristic is the ability to preserve human corneas for up to 14 days under refrigeration (2-8°C) for keratoplasty.
| Acceptance Criteria (Implied) | Reported Device Performance (Cornisol) |
|---|---|
| Similar Intended Use: Hypothermic corneal storage. | Met: Cornisol is a hypothermic corneal storage solution. |
| Similar Indications for Use: Storage for up to 14 days at 2-8°C for keratoplasty. | Met: CORNISOL is a corneal storage solution for storage of human cornea suitable for keratoplasty for up to 14 days under refrigeration (2-8°C). |
| Sterility: Must be sterile. | Met: Cornisol is a sterile solution. Sterilization by sterile filtration (0.2 micron polyether sulfone membrane filters) validated for aqueous extracts ( |
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