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510(k) Data Aggregation

    K Number
    K974406
    Device Name
    ORTHOPLAN
    Manufacturer
    ORTHO-GRAPHICS, INC.
    Date Cleared
    1998-02-18

    (89 days)

    Product Code
    HWT
    Regulation Number
    888.4800
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO-GRAPHICS, INC.

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

    The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letters for OrthoPlan does not contain any information about acceptance criteria, study details, or performance metrics of the device.

    The letters primarily address a substantial equivalence determination and an administrative correction. They state that the device is a "Template for clinical use" (product code HWT) and describe its indications for use as:

    "The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries."

    Since the document does not contain the requested information about acceptance criteria and study data, I cannot fulfill your request to describe them.

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