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510(k) Data Aggregation

    K Number
    K111907
    Device Name
    DYNAMIC DU SERIES PORTABLE DENTAL UNIT
    Manufacturer
    SHANGHAI DYNAMIC INDUSTRY CO., LTD.
    Date Cleared
    2011-12-02

    (150 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K991701,K053555,K080025,K022217
    Why did this record match?
    Reference Devices :

    K991701, K053555, K080025

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

    The DU Series Portable Dental Unit is intended to supply power and serve as a base for dental devices and accessories. This device delivers air, water, vacuum, and electricity to handheld instruments, for use in dental clinics and hospitals. It is designed to be used by professional dental practitioners.

    Device Description
    1. The DU Series Portable Dental Unit is a combination of the speed handpieces, ultrasonic scaler, curing light, 3-way syringe, saliva ejector, clean water bottle, drain bottle, oil free air compressor, and footswitch.
    2. The external AC power source provides electric power to the unit. The self contained air compressor provides air source to speed handpieces. The self contained water system provides water source for the syringe, handpieces and ultrasonic scaler.
    3. The speed handpiece is supplied by the manufacturer of Predicate Device K991701; the ultrasonic scaler is supplied by K053555; the curing light is supplied by K080025. Other accessories are self-produced.
    4. The patient contacting components are in the accessories of speed handpieces and the ultrasonic scaler. All the patient-contacting materials have passed biocompatibility testing according to ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
    AI/ML Overview

    The provided 510(k) summary (K111907) details the acceptance criteria and the study conducted for the DYNAMIC® DU Series Portable Dental Unit.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Standards Met)Reported Device Performance (Compliance)
    ISO 7494-2:2003 Dentistry - Dental units - Part 2: Water and air supplyFound in compliance with the standard
    ISO 9168:2009 Dentistry - Hose connectors for air driven dental handpiecesFound in compliance with the standard
    EN 60601-1:2006 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)Passed safety testing
    IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and testsPassed safety testing
    ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (for patient-contacting components)Patient-contacting materials (in speed handpieces and ultrasonic scaler) have passed biocompatibility testing.

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

    The document states that "Bench testing has been performed on a sample against the standards..." and "The DU Series Portable Dental Unit has passed bench testing...". However, the specific sample size used for the test set (i.e., the number of units tested) is not explicitly stated.

    The data provenance is from bench testing conducted by the manufacturer, Shanghai Dynamic Industry Co., Ltd. in China. It is a prospective test of newly manufactured devices against established performance and safety standards.

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

    This information is not applicable to this type of device and study. The "ground truth" for this device's performance is determined by adherence to established engineering and safety standards (e.g., water/air pressure, electrical safety, biocompatibility). There are no human experts involved in establishing a subjective "ground truth" in the way one would for diagnostic imaging. The standards themselves serve as the objective performance targets.

    4. Adjudication Method for the Test Set:

    This is not applicable. The testing involves objective measurements against predefined criteria in the standards. There is no need for adjudication as the results are quantitative and pass/fail based on the standards.

    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:

    A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a dental operative unit, not an AI-powered diagnostic tool, so such a study would not be relevant.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

    A standalone performance study was not done in the context of an algorithm or AI. The performance studies described are for the physical device itself (bench testing and safety testing) as a standalone unit.

    7. The Type of Ground Truth Used:

    The "ground truth" used for this device's evaluation is based on established international performance and safety standards (ISO and IEC standards) and biocompatibility guidelines. Compliance with these objective, measurable standards constitutes the ground truth for its safety and effectiveness.

    8. The Sample Size for the Training Set:

    This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.

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

    This information is not applicable for the reasons stated in point 8.

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