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510(k) Data Aggregation

    K Number
    K021248
    Device Name
    ICASE
    Manufacturer
    Date Cleared
    2002-09-24

    (158 days)

    Product Code
    Regulation Number
    886.5928
    Reference & Predicate Devices
    N/A
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The icase™ Contact Lens Case is designed for storage of soft (hydrophilic) lenses during chemical disinfection.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a contact lens case, not a study report or clinical trial. Therefore, it does not contain the information requested regarding acceptance criteria, device performance, sample sizes, ground truth, or expert qualifications for AI/ML-based medical devices.

    The document states that the "icase™ Contact Lens Case" is substantially equivalent to legally marketed predicate devices. This means that its safety and effectiveness were demonstrated by showing it is as safe and effective as a device already on the market, not through a study involving acceptance criteria and performance metrics as typically evaluated for AI/ML algorithms.

    Here's why the requested information cannot be provided from this document:

    1. Table of acceptance criteria and reported device performance: This document does not describe performance metrics or acceptance criteria for the contact lens case itself. Its clearance is based on substantial equivalence.
    2. Sample size, data provenance: Not relevant for a substantial equivalence determination of a contact lens case. There's no "test set" in the context of an AI/ML study.
    3. Number of experts, qualifications: Not relevant. The review is by FDA staff based on regulatory requirements.
    4. Adjudication method: Not relevant.
    5. MRMC comparative effectiveness study: Not applicable as this is not an AI-assisted device.
    6. Standalone performance: Not applicable.
    7. Type of ground truth: Not applicable.
    8. Sample size for training set: Not applicable.
    9. How ground truth for training set was established: Not applicable.

    In summary, the provided text is a regulatory clearance letter for a physical medical device (contact lens case) based on substantial equivalence to a predicate device, and it does not contain information related to the rigorous testing and validation processes typically associated with AI/ML-based medical devices.

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