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510(k) Data Aggregation

    K Number
    K000817
    Device Name
    OMEGA II MODULAR TOTAL HIP SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    2000-06-08

    (87 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K070050
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K984227
    Device Name
    OMEGA II MODULAR TOTAL HIP SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    1999-04-08

    (134 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OMEGA® II Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is an FDA 510(k) clearance letter for the OMEGA® II Modular Total Hip System.

    This type of letter grants clearance for a device based on its substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria or the details of a study proving the device meets those criteria. The letter refers to the "indications for use" and mentions general controls and regulations but doesn't elaborate on performance testing or clinical studies for this particular submission.

    Therefore, I cannot extract the following information from the provided text:

    • A table of acceptance criteria and reported device performance: This information is not present.
    • Sample size used for the test set and data provenance: Not mentioned.
    • Number of experts used to establish ground truth and their qualifications: Not mentioned.
    • Adjudication method for the test set: Not mentioned.
    • MRMC comparative effectiveness study details: Not mentioned.
    • Standalone algorithm performance: Not mentioned.
    • Type of ground truth used: Not mentioned.
    • Sample size for the training set: Not mentioned.
    • How ground truth for the training set was established: Not mentioned.
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