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510(k) Data Aggregation

    K Number
    K132315
    Device Name
    ERGONOMIC PRODUCTS WORKSTATION
    Manufacturer
    ERGONOMIC PRODUCTS, INC.
    Date Cleared
    2014-04-18

    (267 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K000966,K935325,K962071
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ergonomic Products Workstation is a dental operative unit, which is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device is to be operated and used by dentists and other legally qualified professionals.

    Device Description

    The Ergonomic Products Workstations provide a consolidated work area for the purpose of delivering air, water, vacuum, and electricity to handheld instruments, and is for use in a professional dental office by professional dental practitioners for administering care to dental patients. Ergonomic Products manufactures dental office delivery units in several formats, all using the same technology - Doctor Workstation, Hygiene Inwall Workstation, Universal Cart and Assistant Cart.

    AI/ML Overview

    The Ergonomic Products Workstation is a dental operative unit.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Conformity to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for safety)Device tested and found to conform.
    Conformity to ISO 7494-1 (Dentistry - Dental units - Part 1: General requirements and test methods)Device tested and found to conform.
    Conformity to ISO 7494-2 (Dentistry - Dental units - Part 2: Water and air supply)Device tested and found to conform.
    Substantial Equivalence to Predicate Devices (A-Dec 4631 Duo Delivery System K000966, A-Dec Cascade 3072 Wallmount K935325, Spirit S1/S2 Pelton & Crane Co. K962071) based on Intended Use and basic feature set.Device found to be substantially equivalent.

    2. Sample size used for the test set and data provenance:
    No specific performance testing was conducted on clinical samples for this device. The assessment of performance was based on adherence to recognized standards and comparison to predicate devices.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
    Not applicable, as no clinical test set requiring expert ground truthing was used. Conformity to standards and substantial equivalence claims were based on engineering and regulatory assessment.

    4. Adjudication method for the test set:
    Not applicable.

    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 operative unit, not an AI-assisted diagnostic or interpretative tool.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
    Not applicable. This device is not an algorithm.

    7. The type of ground truth used:
    The "ground truth" for the device's acceptability was based on established international standards for medical electrical equipment and dental units (IEC 60601-1, ISO 7494-1, ISO 7494-2) and a comparison of its intended use and technological characteristics to legally marketed predicate devices.

    8. The sample size for the training set:
    Not applicable. This device is not an AI/machine learning technology that requires a training set.

    9. How the ground truth for the training set was established:
    Not applicable.

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