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510(k) Data Aggregation

    K Number
    K123608
    Device Name
    ENDO E CLASS
    Date Cleared
    2013-08-16

    (268 days)

    Product Code
    Regulation Number
    872.4200
    Panel
    Dental
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    ENDO E CLASS

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

    For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.

    Device Description

    The motor turned by the power converted into DC24V by controller delivers its turning power to the bur through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Saeyang Microtech ENDO e class device, which is a dental handpiece and accessories. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

    Here's a breakdown based on your requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not define specific acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) that a clinical study would typically assess. Instead, the "acceptance criteria" for this 510(k) revolve around compliance with established safety and performance standards for dental devices and demonstrating substantial equivalence to legally marketed predicate devices.

    The "reported device performance" is essentially a description of the device's features and its compliance with relevant standards.

    Acceptance Criterion (Implicit in 510(k))Reported Device Performance
    Compliance with IEC 60601-1: 1988 +A1 1991,+A2 1995 (Medical Electrical Equipment)Complied
    Compliance with ANSI/AAMI/IEC 60601-1-2: 2007 (Electromagnetic Compatibility)Complied
    Compliance with ISO 3964:1982 (Dental Handpieces - Connections)Complied
    Compliance with ISO 7494-1:2004 (Dental Units - Part 1: General Requirements)Complied
    Compliance with ISO 7785-2:1995 (Dental Handpieces - Part 2: Dental Low-Speed Handpieces)Complied
    Compliance with ISO 11498:1997 (Dentistry - Torque measurement for endodontic handpieces)Complied
    Sterilization Validation PassedValidation performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
    Software Validation PassedValidation performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
    Speed Accuracy Testing PassedTesting performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
    Temperature Rise Testing PassedTesting performed and passed. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
    Substantial Equivalence to Predicate DevicesThe ENDO e class has similar characteristics and intended use as previously cleared devices (AEU-26L, TCM Endo V, ATR TECNIKA). The subject device is substantially equivalent to the predicate devices in intended use, operation, safety and function across key features like motor speed, torque setting, reciprocating drive, foot pedal control, and programmable presets.

    2. Sample size used for the test set and the data provenance

    The document explicitly states: "No clinical testing was conducted." Therefore, there is no test set in the sense of patient data. The "tests" were non-clinical bench tests and compliance with standards. The data provenance would be from manufacturing and engineering tests conducted by Saeyang Microtech in Korea.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

    Not applicable, as no clinical testing with patient data or expert-adjudicated ground truth was performed or required for this type of 510(k) submission.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

    Not applicable, as no test set requiring ground truth adjudication from experts was used.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This device is a dental handpiece (a physical tool), not an AI-powered diagnostic or assistive software. Therefore, an MRMC study or AI-related effectiveness metrics are not relevant.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable. This is a physical medical device, not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    For the non-clinical tests, the "ground truth" was derived from the specifications and requirements of the international and national standards (e.g., IEC 60601-1, ISO 3964) and the performance characteristics of the predicate devices for comparison. For example, for speed accuracy testing, the ground truth would be the expected or specified speed, and the device's measured speed would be compared against that.

    8. The sample size for the training set

    Not applicable, as this is a physical device and not an AI/ML model that requires a training set.

    9. How the ground truth for the training set was established

    Not applicable.

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