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510(k) Data Aggregation

    K Number
    K171815
    Device Name
    Registrado Scan
    Manufacturer
    Date Cleared
    2017-11-15

    (149 days)

    Product Code
    Regulation Number
    872.3690
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    -Occlusal bite registration
    -Fixing of face bow registrations

    • Location material for intraoral pin tracing templates
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) clearance letter for the device "Registrado Scan" does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance.

    The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method for a test set.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Results of a standalone algorithm performance study.
    7. The type of ground truth used.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.

    This type of detailed performance data is typically found in the 510(k) submission itself, which is a much larger document not provided here. The clearance letter only confirms the regulatory decision based on that submission.

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