LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K955777
    Device Name
    PMMA CLASIC
    Manufacturer
    RAND SCIENTIFIC CORP.
    Date Cleared
    1996-05-16

    (148 days)

    Product Code
    HPX
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K955777
    Why did this record match?
    Product Code :

    HPX

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as requested in the prompt. The document describes toxicology tests, eye irritation tests, and cytotoxicity tests for a contact lens material, along with design specifications and a comparison to a predicate device. However, it does not provide details like a table of acceptance criteria vs. reported performance, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, details of MRMC or standalone studies, or ground truth establishment for training and test sets.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1