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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.

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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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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."

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.

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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

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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