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510(k) Data Aggregation

    K Number
    K971002
    Device Name
    SMILE WITH CONFIDENCE
    Manufacturer
    LLOYD V. ZIEMENDORF
    Date Cleared
    1997-07-15

    (118 days)

    Product Code
    EHS
    Regulation Number
    872.3540
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    EHS

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

    Produ elining More Soft الاست u-S

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Smile With Confidence". The letter does not contain information about acceptance criteria or a study proving the device meets them. It primarily states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the given input. The document does not describe:

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