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510(k) Data Aggregation

    K Number
    K014068
    Device Name
    ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
    Manufacturer
    W & H DENTALWERK BUERMOOS GMBH
    Date Cleared
    2002-05-03

    (144 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Indications are very widespread in the field of oral surgery.

    • A. Implant placement, including
        1. preparation of the osteotomy site
        1. bone reconturing, osteoplasty
    • B. Bone grafting
        1. granns
      1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
        1. harvesting autogen living bone
        1. sinus elevation & grafting of alveolar sockets
    • C. Removal and sectioning of teeth ant teeth bone for e.g. impacted third molars and complicated extractions
    • D. Periodontal surgeries
        1. bone recontouring & alveoplasty around living teeth
        1. removal of exoslosis
    • E. Endodontic treatment
        1. Intracanal preparations using rotating NiTi-files
    Device Description

    elcoMED SA-200 and elcoMED SA-200 C consist of a small hand held motor, a foot control and a controller. The system components connect to each other via a proprietary coupling system.

    AI/ML Overview

    The provided 510(k) summary for the elcoMED SA-200 and SA-200 C devices does not contain information related to specific acceptance criteria, performance studies, or AI/ML aspects.

    This submission is for a dental surgical unit, which is a physical device, and the information provided focuses on its technical characteristics, intended use, and substantial equivalence to a predicate device (elcomed 100). The typical contents of a 510(k) for such a device do not usually include the kind of detailed performance study data, ground truth establishment, or AI/ML-specific metrics that your request outlines.

    Therefore, I cannot extract the requested information from the provided text.

    Specifically, the following information is not available in the provided document:

    1. A table of acceptance criteria and the reported device performance: This document primarily discusses the device's technical specifications and intended use, not performance metrics against acceptance criteria.
    2. Sample size used for the test set and the data provenance: No performance test data is presented.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
    4. Adjudication method for the test set: Not applicable.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as this is not an AI/ML diagnostic or image analysis device.
    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
    7. The type of ground truth used: Not applicable.
    8. The sample size for the training set: Not applicable.
    9. How the ground truth for the training set was established: Not applicable.

    The submission is a standard 510(k) for substantial equivalence of a physical medical device, not a software or AI/ML-driven device that would require the types of criteria and studies you've asked about.

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