(177 days)
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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