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510(k) Data Aggregation

    K Number
    K021146
    Device Name
    D/SENSE 1-STEP
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    2002-07-02

    (84 days)

    Product Code
    EJK
    Regulation Number
    872.3250
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    D/SENSE 1-STEP

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental device called "D/Sense 1-Step." This document primarily addresses the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.

    The document does not contain the information requested in your prompt regarding:

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

    This type of information would typically be found in a clinical study report or a more detailed section of the 510(k) submission itself, which is not provided in the given text. The letter only confirms that the FDA reviewed the submission and found the device substantially equivalent.

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