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510(k) Data Aggregation

    K Number
    K072989
    Device Name
    AXIS SYSTEM
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2008-01-28

    (97 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K003518,K031145
    Why did this record match?
    Device Name :

    AXIS SYSTEM

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

    The Axis System is an air-powered dental handpiece system indicated for use in general dentistry.

    Device Description

    The Axis System consists of air-powered dental handpieces with an electronic accessory to limit the speed.

    AI/ML Overview

    This 510(k) summary for the Axis System, a dental handpiece, does not contain the detailed information necessary to answer your request about acceptance criteria and study results.

    Here's why:

    • Device Type: The Axis System is a dental handpiece, which is a mechanical device. The concept of "acceptance criteria" and "device performance" in the context of an AI/software device (which your questions are geared towards, e.g., sensitivity, specificity, ground truth, MRMC studies) is not directly applicable to this type of medical device.
    • Information Provided: The summary focuses on established safety and effectiveness through the prior use of its components and existing predicate devices (Rapidd Highspeed Dental Handpiece and eStylus Electric Motor System). It states, "All of the components found in the Axis System have been used in legally marketed devices and/or were found safe for dental use." It also mentions "performance data provided" and "biocompatibility information provided," but the specifics of what that performance data entails or what the acceptance criteria were for a mechanical device are not detailed within this summary.
    • Regulatory Pathway: This is a Class I device (Dental Handpiece and Accessories), which generally has a less stringent regulatory pathway compared to devices that diagnose or interpret medical images using AI. The 510(k) process for such a device primarily establishes substantial equivalence to a predicate device, focusing on similar indications for use and technological characteristics rather than requiring extensive clinical performance studies to meet AI-specific metrics.

    Therefore, I cannot provide the requested table or elaborations on AI-specific study details because the provided document does not contain information relevant to an AI/software-as-a-medical-device (SaMD) product.

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