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510(k) Data Aggregation

    K Number
    K052367
    Device Name
    SCIENT'X CEMENT RESTRICTOR
    Manufacturer
    SCIENT'X
    Date Cleared
    2005-10-05

    (37 days)

    Product Code
    JDK
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K020836,K031837
    Why did this record match?
    Device Name :

    SCIENT'X CEMENT RESTRICTOR

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

    The Scient'x Cement Restrictor is intended as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

    This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

    Device Description

    The Scient'x Cement Restrictor is a hollow trapezoidal block with 1mm toothed serrations on opposite sides to prevent migration and has a threaded hole on the superior surface to attach an insertion tool. The parts are machined from PEEK that conforms to ASTM F2026-02. As peek is radiolucent gold wire radiographic markers inserted into small holes and serve as location and orientation markers for radiographs.

    AI/ML Overview

    This document is a 510(k) summary for the Scient'x Cement Restrictor and does not contain information about acceptance criteria or a study proving the device meets those criteria. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against pre-defined acceptance criteria in the same way a clinical trial or a more rigorous performance study might for a novel device.

    The information provided focuses on:

    • Device Description: The physical characteristics of the cement restrictor.
    • Intended Use: What the device is designed for.
    • Predicate Devices: Other legally marketed devices to which the Scient'x Cement Restrictor is compared for substantial equivalence.
    • Regulatory Classification: Its class and product code.
    • Labeling Limitations: A warning regarding its use in spinal indications because safety and effectiveness in that context have not been established.

    Therefore, I cannot extract the requested information (acceptance criteria, study summary, sample sizes, ground truth details, MRMC study, standalone performance) from the provided text as it is not present. This document is a regulatory submission, not a performance study report.

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