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510(k) Data Aggregation

    K Number
    K153136
    Device Name
    Initial LiSi Press
    Manufacturer
    GC AMERICA INC.
    Date Cleared
    2016-06-30

    (244 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K051705,K120134
    Why did this record match?
    Device Name :

    Initial LiSi Press

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

    Fabrication of occlusal veneers, thin veneers, veneers, inlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal unit, crown or splinted crown on top of an implant abutment and 3-unit bridge up to the second premolar placed on top of an implant abutment.

    Device Description

    Initial LiSi Press is a press-heated ceramic ingot formed through melting the raw materials at a very high temperature. The melting process eliminates all volatile substances and the final product is a complex oxide ceramic available in various shades and translucencies. All of the components of the applicant device have already been used in the predicate devices. The restorations may be further characterized through layering, glazing and staining, and are then cemented in place as the final restoration. The device is packaged in 5 ingots per tube and is available in a range of shades, including high, medium and low translucency, as well as high and medium opacity.

    AI/ML Overview

    The provided text is a 510(k) premarket notification from the FDA, pertaining to a dental device named "Initial LiSi Press" (a porcelain powder for clinical use). The document primarily focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than presenting a study proving a device meets specific acceptance criteria related to an AI/ML algorithm's performance.

    Therefore, the document does not contain the information required to answer your request about acceptance criteria and a study proving a device meets those criteria, especially in the context of an AI/ML device.

    The document states:

    • "No clinical testing has been performed on this device."
    • The performance testing was "Non Clinical Performance Testing" (biocompatibility assessment and bench performance testing).

    It discusses the device's physical and chemical properties and how it compares to predicate devices, but there is no mention of an AI/ML component, human readers, ground truth establishment, or any of the AI/ML-specific criteria you've listed.

    To answer your question, information from a document describing the development and validation of an AI/ML-powered medical device would be needed.

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