(65 days)
Eusol-C is sterile medium for hypothermic corneal storage intended for corneal storage at 4℃ for up to 14 days, to be used by physicians or highly skilled personnel.
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.
Eusol-C is sterile medium for hypothermic corneal storage intended for corneal storage at 4°C for up to 14 days, to be used by physicians or highly skilled personnel, such as Eye Bank operators. EUSOL-C can be stored at 2-25°C until ready for use. Based on stability studies, peak temperatures up to 42°C do not affect EUSOL-C parameters and performances.
This document is a 510(k) summary for Eusol-C, a sterile medium for hypothermic corneal storage. It describes the device, its intended use, and indicates that it is substantially equivalent to a legally marketed predicate device (Eusol-C Corneal Storage Media, K032422).
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of numerical targets or thresholds for device performance. Instead, it states that "The following tests have been done on Eusol-C:" and lists general categories of tests. The overall conclusion is that "Eusol-C is equivalent in safety and efficacy to the legally-marketed predicate device."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Tests | Done |
| - Physical Tests | Done |
| - Microbiological Tests | Done |
| - Biological Tests and Assays | Done |
| - Performance tests | Done |
| Clinical Tests | Not required |
| Overall Conclusion | Equivalent in safety and efficacy to legally-marketed predicate device. |
| Stability | Can be stored at 2-25°C. Peak temperatures up to 42°C do not affect EUSOL-C parameters and performances. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench tests" and "Performance tests" but does not specify the sample size for these tests. It also does not provide details on data provenance (e.g., country of origin, retrospective or prospective) for any of the non-clinical tests. Clinical tests were "Not required."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given that clinical tests were not required, it's unlikely that "experts" in the traditional sense (e.g., radiologists) were used to establish ground truth for a clinical test set. The non-clinical tests would rely on established laboratory testing methodologies and standards.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable since clinical tests requiring adjudication were not conducted according to the submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document states "Clinical tests: Not required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
This question is not applicable as the device (Eusol-C) is a sterile medium for corneal storage, not an algorithm or AI-based diagnostic tool. Therefore, an "algorithm only" or "standalone" performance study in the context of AI is not relevant.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" would have been established through a combination of:
- Standard laboratory assays and measurements: For physical, microbiological, and biological tests.
- Established performance specifications: For "Performance tests," likely comparing against a predicate device or pre-defined benchmarks for corneal viability/integrity after storage in Eusol-C.
- The document implies comparison to a predicate device for equivalence, suggesting the predicate's performance served as a de-facto ground truth or benchmark.
8. The Sample Size for the Training Set
This question is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is not an AI/ML algorithm that requires a training set.
N/A