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510(k) Data Aggregation

    K Number
    K052703
    Device Name
    ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL
    Manufacturer
    ALDEN OPTICAL LABS., INC.
    Date Cleared
    2005-11-10

    (43 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    K020942,K040523,K042079,K050868,K043232,K160249,K180862,K100867
    Why did this record match?
    Reference Devices :

    K020942, K040523, K042079, K050868, K043232, K160249, K180862, K100867

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

    The Alden Classic (polymacon), Alden Classic 55 (methafilcon A), Alden HP 49 (hioxifilcon B) and Alden HP 59G (hioxifilcon A) Multifocal (Spherical and Toric) soft contact lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia. The lenses are available for either conventional or planned replacement modalities.

    Device Description

    Alden Classic (polymacon) Multifocal Contact Lens (Spherical and Toric designs); Alden Classic 55 (methafilcon A) Multifocal Contact Lens (Spherical and Toric designs); Alden HP 49 (hioxifilcon B) Multifocal Contact Lens (Spherical and Toric designs); Alden HP 59G (hioxifilcon A) Multifocal Contact Lens (Spherical and Toric designs).

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Alden Optical Laboratories, Inc. regarding their multifocal contact lenses.

    **This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI detection algorithms.

    Therefore, I cannot provide the requested information based on the given input text. The document is a regulatory approval letter for a medical device (contact lenses), not a study report or technical specification for an AI-powered diagnostic device.

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