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510(k) Data Aggregation

    K Number
    K974435
    Device Name
    MICHELSON ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    1998-02-19

    (87 days)

    Product Code
    KWQ,KWO
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K012305,K022344
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications:

    • Instability caused by trauma (including fractures); .
    • Instability associated with correction of cervical lordosis, scoliosis and kyphosis . deformity;
    • Instability associated with tumors; .
    • Instability associated with degenerative disk diseases defined as back pain of . discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
    • . Instability from failed previous fusions.
    Device Description

    The Michelson Anterior Cervical Plate System consists of a cervical plate, locking cap and bone screw. The locking cap is preassembled onto the plate.

    AI/ML Overview

    The provided text describes a medical device, the Michelson Anterior Cervical Plate System, and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of the requested AI/algorithm performance analysis.

    The document is a 510(k) summary and an FDA clearance letter for a physical medical device (an anterior cervical plate system). It discusses:

    • Intended Use/Indications for Use: What the device is designed to do (provide stability for cervical spine fusion due to various conditions like trauma, deformity, tumors, degenerative disk diseases, failed fusions).
    • Materials: Titanium alloys.
    • Testing Summary: A brief statement that "Submitted testing demonstrates that the Michelson Anterior Cervical Plate System fatigue strength is comparable to a predicate device and adequate for its intended use." This is a summary of mechanical and material testing, not an AI/algorithm performance study.
    • Predicate Device: The ORION Anterior Cervical Plate, Synthes CSLP System.
    • Regulatory Classification and Warnings: Class II, with specific warnings against pedicular screw fixation.

    Therefore, it is impossible to extract the requested information about acceptance criteria for an AI device and a study proving it meets those criteria from this document. The document pertains to a physical surgical implant, not an AI-powered diagnostic or assistive tool.

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