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510(k) Data Aggregation
(135 days)
LYX
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(110 days)
LYX
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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(177 days)
LYX
The Independent Viewing Chamber (IVC-21) is a sterile container that may be used for the transportation of corneal tissue preserved in Optisol GS storage media.
The Independent Corneal Viewing Chamber (IVC) is a sterile container (consisting of a jar, lid, and o-ring) that may be used for transportation of corneal tissue preserved in Optisol GS storage media.
The provided text describes the acceptance criteria and study proving the device meets those criteria. However, it does not pertain to an AI/ML medical device, but rather a sterile container for corneal tissue. Therefore, many of the requested bullet points, such as those regarding AI model performance, training data, ground truth establishment for AI, MRMC studies, or standalone algorithm performance, are not applicable to this 510(k) submission.
Here's a breakdown of the relevant information from the provided document, addressing the applicable points:
Device: Independent Corneal Viewing Chamber (IVC-21)
Predicate Device: Independent Corneal Viewing Chamber (IVC-12)
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a single, concise table of acceptance criteria with corresponding performance data in the traditional sense for an AI/ML device. Instead, the performance data is described qualitatively or with specific pass/fail statements regarding various tests related to biocompatibility, sterility, and functional requirements for a container.
However, based on the Implicit acceptance criteria from the "Performance Data" section (VII), we can construct a table for the tests performed:
| Test/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional & Simulated Use Testing | Device passes all functional and simulated use tests, with no failures/anomalies. Meets all design input requirements. | "The IVC-21 container passes all functional and simulated use testing with no failures or anomalies noted." |
| "Based on the attached results of the container as designed, passes all of the design input requirements." | ||
| "All tests executed for the Functional Verification Testing (Group 1) and Simulated Use Validation (Group 2) passed all requirements. The IVC-21 container passes all functional and simulated use testing with no failures or anomalies noted. Based on the attached results, the IVC-21 meets or exceeds all of the design input requirements." | ||
| Biocompatibility (General) | Meets requirements of ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1..." Test results satisfy acceptance criteria as defined by associated ISO 10993-1 standards. | "Biocompatibility assessment for the IVC-21 has been performed in accordance with the requirements of ISO 10993-1 and FDA guidance... Test results satisfied the acceptance criteria as defined by the associated ISO 10993-1 standards." |
| Sensitization | No evidence of causing delayed dermal contact sensitization. Not considered a sensitizer. | "The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test." |
| Ocular Irritation | No significant differences in ocular observations compared to control. Not irritating to intraocular tissues. | "There were no significant differences in ocular observations between eyes treated with the test article extract and those treated with the control vehicle. The test article extract was not irritating to intraocular tissues." |
| Cytotoxicity | No evidence causing cell lysis or toxicity. Grade less than 2 (mild reactivity). | "The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity)." |
| Systemic Toxicity, Genotoxicity, Pyrogenicity | Assessed by chemical characterization and analytical chemistry (implying acceptable results). | "Systemic toxicity, genotoxicity, and material mediated pyrogenicity were assessed by chemical characterization and analytical chemistry." (No explicit "pass" statement, but implied by lack of mention of failure) |
| Limulus Amebocyte Lysate (LAL) / Endotoxin | Measured EU level lower than 0.2 EU/device. Not likely to result in TASS. | "IVC-21 passed the BET testing. The measured EU level was lower than the acceptance criterion of 0.2 EU/device..." "Based on these test results, IVC-21 is not likely to result in Toxic Anterior Segment Syndrome (TASS)." |
| Sterility | Maintained after gamma sterilization (implied). | No explicit performance data provided beyond "Gamma" sterilization method and "25 kGy" minimum sterilization dose, but the functional tests were done on gamma-sterilized product, implying success. |
The following points are not applicable to this 510(k) submission for a physical medical device (corneal viewing chamber) as it does not involve an AI/ML component.
- 2. Sample size used for the test set and the data provenance: Not applicable for a non-AI/ML device. Tests were performed on the device itself (e.g., extracts, or the physical container). The numbers relate to test animals (e.g., 10 guinea pigs, 6 rabbits) or in vitro cell cultures, not data for an algorithm. Data provenance (country of origin, retrospective/prospective) is typically for clinical data or imaging datasets, which are not relevant here.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Relates to expert consensus for AI/ML model ground truth.
- 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. Relates to reader studies for AI/ML performance.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Applies to AI/ML algorithm performance.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. Refers to ground truth for AI/ML model validation. For a physical device, performance is evaluated against defined physical, chemical, and biological standards.
- 8. The sample size for the training set: Not applicable. Relates to AI/ML model training data.
- 9. How the ground truth for the training set was established: Not applicable. Relates to AI/ML model training data.
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(56 days)
LYX
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.
Not Found
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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(108 days)
LYX
Hypothermic (2-8°C) human corneal storage for 14 days
Cornea Cold® is a sterile hypothermic corneal storage medium intended for human corneal storage at 2-8°C, for up to 14 days. Corneas are directly placed in Cornea Cold storage medium after surgery, and stored in eye banks between +2°C for a maximum of 2 weeks. The shortest storage time is determined by the time needed to obtain serology results of the donor. It is for single use, to be used by physicians or highly skilled personnel such as bank operators. The device gets into direct contact with the patient by accumulation in the cornea graft.
The provided text describes the 510(k) submission for the Cornea Cold® device, a hypothermic corneal storage medium. The submission asserts substantial equivalence to a predicate device, Optisol-GS. However, the document does not contain specific acceptance criteria, detailed study results, or the other requested information for algorithm performance.
The document is a regulatory submission for a medical device that preserves biological material (corneas), not an AI/ML algorithm that analyzes data to produce performance metrics like sensitivity, specificity, or AUC. Therefore, a direct answer to the prompt's request for acceptance criteria and studies proving an algorithm's performance cannot be provided from this document.
The "Performance" section within the table comparing the device to the predicate device simply states "Substantially equivalent to predicate device." This indicates that the performance was deemed similar enough to the legally marketed predicate device to establish substantial equivalence, without providing specific metrics or a detailed study report.
In summary, the provided document does not contain the information required to answer the prompt regarding acceptance criteria and performance studies of a device that uses an algorithm. It describes a medical device in the context of its regulatory clearance rather than its analytical or diagnostic performance metrics.
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(415 days)
LYX
LIFE4°C is indicated for storage of human corneas suitable for keratoplasty up to 14 days under refrigeration (2-8°C).
Life49C is sterile, non-pyrogenic, advanced buffered corneal preservation medium which is supplemented with chondroitin sulfate (membrane stabilizer), recombinant human insulin (cell metabolism enhancer), Dextran (osmotic agent), glutathione (antioxidant, free-radical scavenger, enzyme cofactor), stabilized L-glutamine , ATP precursors, nutrient cell supplements, amino acids, vitamins, trace elements, gentamycin, streptomycin and phenol red (pH indicator).
The provided text is a 510(k) summary for a medical device called Life4°C, a sterile medium for hypothermic corneal storage. The document focuses on establishing substantial equivalence to a predicate device, Optisol GS Corneal Storage Media (K924165), rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, much of the requested information regarding acceptance criteria, performance, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.
Here's a breakdown of what can be extracted and what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicit Acceptance Criteria: Not explicitly stated in terms of quantifiable thresholds for performance metrics. The submission relies on demonstrating substantial equivalence to a predicate device. | Long-term Stability: Tests were performed, but no specific performance metrics (e.g., maximum allowable degradation, acceptable deviation from baseline) or actual results are reported. |
| Safety Testing: Tests were performed, but no specific safety endpoints or results are reported. | |
| Performance Characteristics: Tests were performed, but no specific performance characteristics or results are reported. | |
| Sterilization Validation: Tests were performed, but no specific criteria or validation results are reported. | |
| Comparison with Predicate Device: Tests were performed (implicitly to show equivalence in performance), but no direct comparison data or specific metrics are provided. | |
| Intended Use: Storage of human corneas suitable for keratoplasty up to 14 days under refrigeration (2-8°C). | Implied Performance: The device performs equivalently to the predicate, which is approved for the same intended use. No specific "success rate" or "retention of viability" metrics are provided for Life4°C itself. |
2. Sample size used for the test set and the data provenance
- The document mentions "Non-clinical tests" including "Long-term Stability," "Safety Testing," "Performance Characteristics," "Sterilization Validation," and "Comparison with Predicate Device."
- However, it does not provide any details on the sample sizes used for these tests.
- Data Provenance: Not specified. It's implied these are internal company tests conducted by Numedis, Inc., but no country of origin or whether they were retrospective or prospective is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. The nature of the tests (stability, sterility, safety, performance characteristics of a storage medium) typically does not involve human experts establishing "ground truth" in the same way an AI diagnostic device would. These tests would involve laboratory measurements against established standards or predicate device performance.
- The document explicitly states "(b) Clinical tests - Not required," which further indicates no human expert-based ground truth establishment as would be present in a clinical trial.
4. Adjudication method for the test set
- Not applicable / Not provided. Since there's no mention of human expert assessment or ground truth establishment in a diagnostic sense, there is no adjudication method described.
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
- No, an MRMC comparative effectiveness study was not done.
- The device is a corneal storage medium, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a corneal storage medium, not an algorithm or AI system. Its performance is evaluated through non-clinical laboratory tests, not standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in terms of "ground truth" as a diagnostic reference. For tests like long-term stability and sterilization validation, the "ground truth" would be established acceptance limits based on scientific principles and regulatory standards (e.g., cell viability thresholds, sterility assurance levels).
- For the "Comparison with Predicate Device," the predicate's established performance serves as a reference.
8. The sample size for the training set
- Not applicable / Not provided. The device is a physical sterile medium, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no AI model or training set, this information is irrelevant to the described device.
In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Life4°C corneal storage medium to a predicate device (Optisol GS) through non-clinical laboratory tests. It explicitly states that clinical tests were "Not required." Therefore, the detailed information typically requested for AI/diagnostic device performance studies (like expert involvement, ground truth, sample sizes for training/test sets, and MRMC studies) is not present in this document. The "acceptance criteria" are implicitly met by demonstrating performance comparable to the predicate for parameters like stability, safety, and general performance characteristics, though the specific quantifiable criteria and results are not detailed.
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(65 days)
LYX
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.
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(132 days)
LYX
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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(231 days)
LYX
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