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510(k) Data Aggregation

    K Number
    K020617
    Device Name
    NSI HEXED AND NON-HEXED IMPLANT SYSTEM
    Manufacturer
    NSI
    Date Cleared
    2002-05-10

    (74 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K003620,K951111,K944068,K874590,K894594,K925773,K002475,K925769,K925777
    Predicate For
    K033171,K052490,K053478,K061169,K070841,K070905,K071161,K161548,K163634
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.

    Device Description

    The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.

    AI/ML Overview

    The provided document is a 510(k) summary for a dental implant system (NSI Hexed and Non-Hexed Implant System). It explicitly states that "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." Therefore, there is no information available in this document regarding acceptance criteria or a study proving device performance against such criteria.

    The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and intended use, rather than on new clinical performance data.

    Consequently, I cannot provide the requested information, which includes:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and their qualifications
    4. Adjudication method for the test set
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
    6. If a standalone performance study was done
    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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