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510(k) Data Aggregation

    K Number
    K955838
    Device Name
    ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)
    Manufacturer
    ATRIX LABORATORIES, INC.
    Date Cleared
    1996-03-21

    (90 days)

    Product Code
    NPK
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but without further context, I cannot fulfill your request. The provided text is a letter from the FDA regarding a substantially equivalent determination for a medical device. It does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

    To answer your questions, I would need a document that describes:

    • The specific acceptance criteria for the device's performance.
    • The details of the study conducted to prove the device meets these criteria.
    • Information about the test and training sets, including sample sizes, data provenance, and how ground truth was established.
    • Details about expert involvement and adjudication methods.
    • Whether any comparative effectiveness studies were performed.
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