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510(k) Data Aggregation

    K Number
    K042831
    Device Name
    ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)
    Manufacturer
    REICHERT INC.
    Date Cleared
    2004-10-28

    (15 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)

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

    ATP is intended to measure intra-ocular pressure and comeal thickness of the eye for the purpose of aiding in the diagnosis and monitoring of glaucoma.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the "ATP (Auto Non-Contact) Tonometer/Pachymeter)" and an "Indications for Use Form" for a diagnostic ultrasound.

    Therefore, I cannot provide the requested information, including:

    • A table of acceptance criteria and reported device performance
    • Sample sizes and data provenance for the test set
    • Number and qualifications of experts for ground truth establishment
    • Adjudication method
    • Results of a multi-reader multi-case (MRMC) comparative effectiveness study
    • Results of a standalone performance study
    • Type of ground truth used
    • Sample size for the training set
    • Method for establishing ground truth for the training set
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