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510(k) Data Aggregation

    K Number
    K972168
    Device Name
    SIDEXIS DIGITAL RADIOGRAPHY SYSTEM
    Manufacturer
    PELTON & CRANE CO.
    Date Cleared
    1997-09-05

    (88 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K992644
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SIDEXIS Digital Radiography System consisting of digital sensor, image display is indicated to replace conventional radiographic film when used with extraoral source X-ray systems which are intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

    Device Description

    SIDEXIS Digital Radiography System consisting of digital sensor, image display

    AI/ML Overview

    The provided FDA 510(k) premarket notification does not contain information about acceptance criteria, device performance, or any clinical study details. The document is a clearance letter for the SIDEXIS Digital Radiography System, indicating its substantial equivalence to previously marketed devices for dental radiographic examination and diagnosis.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance
    2. Sample size used for the test set and data provenance
    3. Number of experts used to establish ground truth and their qualifications
    4. Adjudication method
    5. Multi-reader multi-case (MRMC) comparative effectiveness study details
    6. Standalone performance details
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established

    The document focuses on the regulatory clearance for the device based on substantial equivalence, rather than detailing a clinical performance study.

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