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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

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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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.

The provided text describes a 510(k) premarket notification for a medical device called "Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc." This submission is for a modification to an existing device, specifically a change in the silicone material of a gasket and its coating within the lens case.

The document does not contain the kind of detailed acceptance criteria and study information typically associated with AI/ML-based medical devices or diagnostic tools. Instead, it focuses on the safety and efficacy of a contact lens care product and its components. Therefore, many of the requested fields related to AI/ML study design will not be applicable.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

1. A table of acceptance criteria and the reported device performance

• No negative effect on functionality characteristics of the gasket in the lens case assembly.
  (Implicitly, the criteria would be acceptable adhesion and no degradation of the gasket's designed function). | "Design functionality tests were conducted to confirm that the coating adheres reliably to the silicone material and does not affect negatively any functionality characteristics of the gasket in the lens case assembly." (Implicitly successful, as the conclusion states substantial equivalence and safety.) |
  | Overall Safety & Efficacy| The modified device must be "substantially equivalent" to predicate devices, ensuring continued safety and efficacy for its intended use (storage of soft and RGP contact lenses during disinfection with 3% hydrogen peroxide solution). The modifications should not change the indications for use or the basic technical principle of the device. | "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." (Met) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the tests conducted (biocompatibility, physicochemical, and design functionality). It also does not provide details on data provenance beyond indicating the submitter (Alcon Laboratories, Inc., USA, with a contact in Germany) and the FDA's review process. These types of tests are typically bench tests or laboratory assessments of materials, not clinical studies with human subjects or retrospective/prospective data collection in the sense of an AI/ML diagnostic.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the scope of this regulatory submission. The "ground truth" here is established by adherence to recognized international standards (ISO, USP, EP) and internal engineering design specifications for material properties and device function. There were no human experts establishing a "ground truth" for a diagnostic outcome.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The tests described are laboratory and bench tests, not assessments requiring human adjudication of diagnostic outcomes.

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/ML device or a diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" or reference standards used are:

• International Standards: Subparts of ISO 10993 (for biocompatibility).
• Pharmacopeia Standards: USP (United States Pharmacopeia) and EP (European Pharmacopoeia) requirements (for extractable and leachable testing).
• Engineering Design Specifications: Related to coating adhesion and overall functionality of the gasket within the lens case.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not involve a "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device and does not involve a "training set."

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For use in simultaneous cleaning, daily protein removal, disinfecting, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

The two color AOCup Lens Case with AODisc is equivalent to the predicate device except modifications of colorants and minor modifications to basket geometry.

It 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 the strong oxidizing agent hydrogen peroxide to harmless water and oxygen gas.

The modifications of colorants and basket geometry do not change any indications for use nor the basic technical principle of the device functions.

The provided text is a 510(k) Premarket Notification from the FDA regarding a contact lens care product. It does not contain information about an AI-powered device or a study involving acceptance criteria, expert ground truth, multi-reader multi-case studies, or training/test set details as requested in your prompt.

Therefore, I cannot provide the information you asked for based on the input text. The document is a regulatory filing for a physical medical device (contact lens case and solution), not a software or AI-based device that would require the type of performance evaluation details you've described.

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