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510(k) Data Aggregation
(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 (< 0.25 EU/ml endotoxin) and finished product endotoxin specification (5 EU/device) confirmed. Vial caps sterilized by EO (limits for EO/ECH exposure met). |
| Physical/Chemical Stability: Maintain pH, contain proper nutrients, etc. | Met: Buffered corneal preservation medium with ingredients (Chondroitin Sulphate, Dextran 40, HEPES Buffer, Sodium Pyruvate, Gentamycin, Streptomycin, Sodium Bicarbonate, Medium 199, Minimum Essential Medium, Glutamax i200, Vitamin B12, Phenol Red Indicator, Recombinant Human Insulin, Purified Water IP). Designed to maintain pH for endothelial cell viability, nutrient delivery, and prevent degradation. |
| Biocompatibility: Non-toxic, non-sensitizing, non-irritating. | Met: Chemical characterization performed. No novel ingredients. Biocompatibility testing conducted: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Acute ocular irritation testing (ISO 10993-10). These tests would confirm non-toxicity and safety for use with human tissue. |
| Preservation Efficacy (Implied Equivalence to Predicate): Maintain endothelial cell viability and structural/functional integrity for 14 days. | Met: Two in-vitro studies conducted: 1. Prospective, in vitro, randomized study using paired donor corneas. Assessments: endothelial cell loss, endothelial cell density (ECD), coefficient of variance, and percentage hexagonality on days 3, 7, 10, and 14. Result: Indicated Cornisol adequately preserved the cornea for up to 14 days in storage. 2. Comparison study with Optisol-GS (predicate) on donor corneas. Immunostaining for structural integrity (ZO-1, Phalloidin) and functionality (Na+/K+ ATPase). Result: Cornisol had similar performance in preserving cell structural integrity and functionality. |
| Shelf-Life: 12 months. | Met: Shelf life of 12 months when stored at 2℃ to 8℃. |
| Packaging Integrity: Maintain sterile barrier. | Met: Tested on every batch of components (vial and caps) by dye ingress/egress vacuum testing. Finished product also tested using inverted vacuum challenge testing. Confirmed ability to maintain sterile barrier. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Study 1 (Prospective, in vitro, randomized): "paired donor corneas" - The exact number is not specified in the provided text.
- Study 2 (Comparison with Optisol-GS): "donor corneas" - The exact number is not specified.
- Data Provenance: The studies were "in vitro," implying lab studies using donated human corneas. The country of origin for the donor corneas is not specified. It is retrospective in the sense that they are studying the effect on previously donated corneas, but the study design (e.g., "prospective, in vitro, randomized") refers to the execution of the experimental work.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as this is a biochemical/biophysical product evaluation, not an AI diagnostic device. Ground truth is established by objective measurements (e.g., endothelial cell counts, protein expression via immunostaining) on the preserved corneas, not by expert interpretation of images.
4. Adjudication Method for the Test Set
Not applicable for this type of product testing. The "ground truth" is measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this type of study is for diagnostic AI devices involving human interpretation of medical images. Cornisol is a storage solution.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no AI algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance evaluation was based on objective biological and physical measurements from ex-vivo human corneas after storage. These included:
- Endothelial cell loss
- Endothelial cell density (ECD)
- Coefficient of variance of endothelial cells
- Percentage hexagonality of endothelial cells
- Immunostaining for markers of structural integrity (ZO-1, Phalloidin)
- Immunostaining for markers of functionality (Na+/K+ ATPase)
8. The Sample Size for the Training Set
Not applicable. There is no AI model being trained. The "training" for this product type involves R&D and formulation optimization, not data-driven machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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