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510(k) Data Aggregation

    K Number
    K161580
    Device Name
    Premier Sealant
    Manufacturer
    PREMIER DENTAL COMPANY PRODUCTS
    Date Cleared
    2016-10-18

    (132 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K243254
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or "initial layer" of composite restorations.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) premarket notification for the "Premier Sealant" does not contain any information about a medical device that uses artificial intelligence (AI) or machine learning.

    The document is a standard FDA clearance letter for a dental pit and fissure sealant, which is a physical product, not a software-based diagnostic or assistive device that would involve acceptance criteria for AI performance.

    Therefore, I cannot provide the requested information regarding:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test set or data provenance.
    3. Number of experts or their qualifications for ground truth.
    4. Adjudication methods.
    5. MRMC comparative effectiveness study or human reader improvement with AI.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Training set sample size.
    9. How ground truth for the training set was established.

    This information is simply not present in the provided text as the device in question is a traditional dental material, not an AI-powered diagnostic tool.

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