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510(k) Data Aggregation
(28 days)
For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.
The device is a specialized lens case consisting of a transparent cup with a connected unit of screw cap, lens holders (baskets) and platinum-coated neutralization disc. The platinum catalyst coating and shape of the plastic disc are designed to effectively neutralize hydrogen peroxide in the lens care system to harmless water and oxygen gas.
This looks like a 510(k) summary for a medical device with a minor modification (change in silicone material of a gasket). Generally, devices with such minor changes do not contain extensive studies as they are not typically required for demonstrating substantial equivalence. The document confirms this in Section VII, "Performance Data," stating that the device was evaluated in "biocompatibility, physicochemical and design functionality tests."
Given the information provided in the 510(k) summary:
- No extensive clinical study was conducted or is reported for the device. The primary purpose of this 510(k) (K191795) is to demonstrate substantial equivalence to a legally marketed predicate device after a change in a gasket material.
- The "performance data" mentioned refers to nonclinical testing, which is generally not a clinical trial involving human subjects or AI algorithm performance as you might expect in more complex device submissions.
- The information you are asking for (e.g., sample size for training set, MRMC study, number of experts for ground truth) is typical for AI/ML-driven devices or devices requiring extensive clinical validation. This device (AOCup Lens Case with AODisc) is a contact lens case, which falls under a different regulatory pathway and testing requirements.
Therefore, I cannot provide the detailed information you requested about acceptance criteria and study particulars in the format you specified, as those types of studies and criteria are not described in this 510(k) submission for this specific device. The provided text outlines a regulatory submission for a contact lens case after a material change, not an AI or imaging-based diagnostic device.
However, I can interpret the "Performance Data" section to infer general acceptance criteria and the "study" (nonclinical testing) that proves the device meets them:
General Acceptance Criteria and "Study" (Nonclinical Testing) for AOCup Lens Case with AODisc (K191795)
The primary acceptance criterion for this 510(k) submission is to demonstrate that the modified device (with the new silicone gasket material) maintains the same safety and effectiveness as the predicate device. This is achieved through nonclinical testing to ensure the material change does not negatively impact the device's intended function or biocompatibility.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|---|
| Biocompatibility | The new gasket material must be biocompatible (e.g., non-cytotoxic, non-irritating, non-sensitizing) and not leach harmful substances. | "The AOCup Lens Case with AODisc and the changed gasket was evaluated in biocompatibility... tests." |
| (Implicitly, these tests were successful as the submission concludes substantial equivalence and safety.) | ||
| Physicochemical Properties | The new gasket material must maintain appropriate physical and chemical properties (e.g., durability, chemical stability) for its function as a seal in the lens case, particularly in contact with hydrogen peroxide solution. | "The AOCup Lens Case with AODisc and the changed gasket was evaluated in... physicochemical... tests." |
| (Implicitly, these tests were successful, indicating the material change did not compromise the physical or chemical integrity of the gasket or its interaction with the solution.) | ||
| Design Functionality | The device, with the new gasket, must continue to function as intended (e.g., seal properly, prevent leaks, accommodate lenses, allow neutralization). | "The AOCup Lens Case with AODisc and the changed gasket was evaluated in... design functionality tests." |
| "Dimensions and technical function of the gasket are unchanged." | ||
| "The modifications of gasket material does not change any indications for use nor the basic technical principle of the device functions." | ||
| (Implicitly, these tests were successful, confirming the gasket still performs its sealing role and the overall lens case maintains its designed function for storage and disinfection.) | ||
| Substantial Equivalence (Overall) | The modified device must be as safe and effective as the predicate device, and the material change must not raise new questions of safety or effectiveness. | "Successful results of all nonclinical testing supported the substantial equivalence and therefore safety and efficacy of the modified AOCup Lens Case with AODisc to the existing product for its intended use." |
Regarding the other points in your request:
- 2. Sample sized used for the test set and the data provenance: Not applicable. These were nonclinical (bench) tests, not involving a "test set" in the context of clinical data or AI algorithms.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for nonclinical tests is based on established testing standards and specifications, not expert interpretation of data.
- 4. Adjudication method: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an imaging or diagnostic device that would require such a study.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This device does not involve an algorithm.
- 7. The type of ground truth used: For biocompatibility, physicochemical, and design functionality tests, the "ground truth" would be defined by the established industry standards, test methods (e.g., ISO standards for biocompatibility), and internal product specifications for the performance of the gasket and the lens case.
- 8. The sample size for the training set: Not applicable. There is no training set for this type of device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a regulatory submission for a physical medical device (contact lens case) with a minor material change. The "study" refers to nonclinical laboratory and bench testing rather than clinical trials or AI performance evaluations, therefore, most of your requested information is not relevant to this specific type of device and submission.
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