(132 days)
Eusol-C is indicated for corneal storage for up to 14 days.
Eusol-C is indicated for the storage of donor corneas for up to 14 days.
Eusol-C is sterile medium for hypothermic corneal storage intended for corneal storage at 4℃ for up to 14 days.
This document describes a 510(k) submission for the Eusol-C corneal storage medium. The information provided is primarily focused on regulatory submission and does not detail a clinical study with an AI device or a direct comparison of device performance against established acceptance criteria in the manner requested for an AI/device performance study.
Based on the provided text, here's a breakdown of the information, with explicit notes where the requested details are not present:
The device in question, Eusol-C, is a sterile medium for hypothermic corneal storage, not an AI-powered device. Therefore, the questions related to AI performance, such as MRMC studies, standalone algorithm performance, and training/test set details for AI, are not applicable.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the document. The submission aims to demonstrate substantial equivalence to a predicate device. | Not explicitly defined in the document as a "performance metric" against a pre-set acceptance criteria. The submission states "Eusol-C is equivalent in safety and efficacy to the legally-marketed predicate device" (Optisol-GS Corneal Storage Media, K924165). |
Note: For medical devices, "acceptance criteria" are usually specific metrics (e.g., cell viability percentage, storage duration without adverse events) that the new device must meet to be considered safe and effective. This document focuses on demonstrating equivalence to a predicate device, rather than meeting novel performance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical "test set" in the context of an AI study or a patient-based clinical trial is described. The submission refers to "non-clinical tests" and explicitly states "Clinical tests: Not required."
- Data Provenance: Not applicable for a clinical test set. The non-clinical tests (long-term stability, accelerated aging, container closure, performance characteristics, sterilization validation, comparison with predicate device) would have been conducted by the manufacturer, AL.CHI.MI.A. S.r.l. in Italy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of expert-derived ground truth for diagnoses. For the non-clinical tests, the "ground truth" would be established by standard laboratory methods and comparisons to the predicate device's characteristics. For example, for "long-term stability," the ground truth would be chemical and physical properties measured over time.
8. The sample size for the training set
- Not applicable. This is not an AI device and thus has no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device.
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