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510(k) Data Aggregation

    K Number
    K123695
    Device Name
    TRAUS SIP10
    Manufacturer
    SAESHIN PRECISION CO., LTD.
    Date Cleared
    2012-12-18

    (15 days)

    Product Code
    EKY
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K052741,K011061
    Why did this record match?
    Product Code :

    EKY

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

    The TRAUS SIP10 is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.

    Device Description

    The TRAUS SIP10 is an AC-powered device that includes a hand-held motor, controller, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.

    AI/ML Overview

    The provided text is a 510(k) summary for the Saeshin TRAUS SIP10 dental handpiece. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or adjudication methods for an AI-powered device. Therefore, I cannot generate the requested table and information based on this document.

    The document discusses:

    • Company and Device Information: Saeshin Precision Co., Ltd., and the TRAUS SIP10 dental handpiece.
    • Predicate Device: ImplantMED SI-915/923, K052741, and Surgical Contra-Angle Handpiece WS-75E/KM, K011061.
    • Device Description and Indication for Use: The TRAUS SIP10 is an AC-powered dental handpiece for surgery, implantology, maxilla-facial surgery, and endodontics.
    • Bench Testing and Standards Conformance: Biocompatibility testing (ISO 10993-1) and conformance to electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2) are mentioned to demonstrate safety and effectiveness.
    • Substantial Equivalence: The document concludes that the TRAUS SIP10 is substantially equivalent to the predicate device based on similar intended use, material, design, and use concept.

    There is no mention of AI, machine learning, or software-based performance evaluation studies that would typically involve acceptance criteria, test sets, ground truth, or expert review as described in your request.

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