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510(k) Data Aggregation

    K Number
    K033630
    Device Name
    MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
    Manufacturer
    RHEIN 83 SRL
    Date Cleared
    2004-04-21

    (156 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK

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

    QUICK COUPLING DEVICE FOR DENTAL PROSTHESES

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for dental prostheses, which primarily focuses on substantial equivalence to predicate devices rather than the specifics of a performance study with acceptance criteria.

    The letter acknowledges the device's clearance for marketing but does not include:

    • A table of acceptance criteria or reported device performance metrics.
    • Information on sample sizes, data provenance, number of experts for ground truth, or adjudication methods.
    • Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • The type of ground truth used, training set size, or how ground truth was established for a training set.

    The document is a regulatory approval, not a technical report on device performance validation.

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