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510(k) Data Aggregation

    K Number
    K033198
    Device Name
    APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
    Manufacturer
    APOZA ENTERPRISE CO. LTD.
    Date Cleared
    2004-04-30

    (211 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K961158
    Why did this record match?
    Device Name :

    APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2

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

    The Apoza Selector U2 is designed for the dentists to remove the calculus or stains on surface of teeth er clean the root canal ( with endo-kit) in the prophylaxis procedures.

    Device Description

    Not Found

    AI/ML Overview

    The APOZA ULTRASONIC SCALER AND ENDODONTIC'S UNIT Models: SELECTOR U2 did not provide specific acceptance criteria or an analytical study. The information focuses on its substantial equivalence to a predicate device and its intended use.

    Here's a breakdown of the available information based on your request:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Not explicitly stated in the provided document. The submission relies on "substantial equivalence" to a predicate device.The device's performance is validated through "performance testing" to show substantial equivalence to the predicate device, SATELEC SUPRASSON P5 BOOSTER (K961158). The document states that the comparison and validation results "show that the subject device is substantially equivalent to predicated device and is safe and effective in its intended use."

    2. Sample Size Used for the Test Set and the Data Provenance

    This information is not provided in the document.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    This information is not provided in the document.

    4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

    This information is not provided in the document.

    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

    There is no mention of an MRMC comparative effectiveness study, nor is there any indication that AI is involved in this device. This is a conventional medical device, an ultrasonic scaler.

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

    This information is not applicable as the device is an ultrasonic scaler, not an algorithm.

    7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

    The document broadly mentions "performance testing" and comparison with a predicate device to establish safety and effectiveness. It does not explicitly state the type of ground truth used, but it would likely involve standard dental performance metrics for ultrasonic scalers (e.g., calculus removal efficiency, tip vibration patterns, power output stability, safety parameters) rather than complex clinical outcomes data or expert consensus on diagnostic tasks.

    8. The Sample Size for the Training Set

    This information is not provided in the document.

    9. How the Ground Truth for the Training Set Was Established

    This information is not provided in the document. As this is a traditional medical device, a "training set" in the context of machine learning is not applicable here. The "training" would refer to internal validation and testing during the device's design and manufacturing process, which is not detailed in a 510(k) summary in this manner.

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