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510(k) Data Aggregation

    K Number
    K030987
    Device Name
    CONTACT LENS STORAGE CASE
    Manufacturer
    PELICAN PRODUCTS
    Date Cleared
    2003-06-12

    (76 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PELICAN PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Storage of soft (hydrophilic)/rigid gas permeable and hard contact lenses during chemical disinfection. Use during chemical disinfection only. DO NOT USE WITH HEAT

    Device Description

    The Pelican Products, Inc contact lens storage cases are intended for use for storage of soft, hard and rigid gas permeable contact lenses during chemical disinfection. Not to be used for heat disinfection.

    AI/ML Overview

    The provided text describes a 510(k) summary for Pelican Products, Inc. contact lens storage cases. It does not contain information about an AI-powered device or a study involving AI performance. Therefore, I cannot generate the requested table and information about acceptance criteria and AI device study for this document.

    The document discusses:

    • Device: Contact lens storage cases (deep well cases, ultra clear single lens cases, billboard lens cases, curved lens cases, and lens vials).
    • Intended Use: Storage of soft (hydrophilic)/rigid gas permeable and hard contact lenses during chemical disinfection. Specifically states "DO NOT USE WITH HEAT."
    • Substantial Equivalence: Claimed to be substantially equivalent to Alcon contact lens case.
    • Safety and Effectiveness Studies: Cytotoxicity, systemic toxicity, and ocular irritation studies were performed in accordance with FDA guidelines for "Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products."
    • Results: No evidence of cellular or systemic toxicity, or ocular irritation was found.

    To summarize, this document pertains to a traditional medical device (contact lens storage cases) and not an AI-enabled medical device. Therefore, no information regarding AI performance, sample sizes for test/training sets for AI, ground truth establishment, or multi-reader multi-case studies can be extracted from the provided text.

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