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510(k) Data Aggregation

    K Number
    K050744
    Device Name
    KAVO ERGOCOM/ERGOCAM
    Manufacturer
    KAVO AMERICA CORPORATION
    Date Cleared
    2005-04-21

    (30 days)

    Product Code
    LLZ,MUH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K012439
    Predicate For
    K060178
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For acquiring, viewing, handling, and storage of dental color images and radiographs.

    Device Description

    KaVo ERGOcom®/ERGOcam® system consists of four main components:

    • The ERGOcom® Video control box.
    • One of two versions of the ERGOcam® Cameras: The ERGOcam® 3 of the ERGOcam® 4 camera.
    • A video display, flat panel color from 15 to 19" with touch screen control.
    • A PC compatible computer with the KaVo Device Interface System Software installed. The Device Interface System has the following components:
        1. CCCDIS. The CCCDIS software is used to administer and configure the software components in the KaVo Device Interface System. The CCCDIS acts as the interface of the KaVo Device Interface System with third party applications
      • ERGOcam Control The ERGOcam Control software is used to configure individual parameters of the ERGOcam 4
      • ERGOcom Control The ERGOcom Control software is used for the PC-assisted status display, configuration and service support of the ERGOcom 3.
      • ERGOvideo Control The ERGOvideo Control software is used for generating and displaying video imaging data created with ERGOcom 2 / ERGOcom 3 andERGOcam 3 / ERGOcam 4
      • ERGOcam Viewer The ERGOcam Viewer is used for demonstrating the use of the ERGOvideo Control, ERGOcam Control and ERGOcom Control. The ERGOcam Viewer is used to store and administer imaging data that have been generated with the software components referred to above.
      • VirtualCom2 VirtualCom2 is used to convert the foot starter and camera cradle signals from ERGOcom 3 to a format that is compatible with ERGOcom 2. These signals are only used to control program modules within a practice management software that allows the recording of images with a KaVo intraoral camera, thereby meeting the interface specification for the serial interface of ERGOcom 2

    The intraoral camera emits video signals which generate an image of the area under inspection (the patient's oral cavity for instance) on a screen or other visual display medium. The generated image is used for the patient's information and to support the diagnosis.

    AI/ML Overview

    The provided text is a 510(k) summary for the KaVo ERGOcom®/ERGOcam® Dental Image Management System. It states that the device is substantially equivalent to a predicate device (DentalEye 2, K012439) and does not contain detailed information about specific acceptance criteria, performance studies, or efficacy claims in the way a clinical study report would.

    Therefore, the following information is not available in the provided document:

    • A table of acceptance criteria and reported device performance (beyond basic system specifications and functional equivalence).
    • Sample sizes used for test sets.
    • Data provenance (country of origin, retrospective/prospective).
    • Number and qualifications of experts for ground truth establishment.
    • Adjudication method for the test set.
    • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Results of a standalone (algorithm-only) performance study.
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance evaluation of clinical effectiveness.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    The document focuses on demonstrating substantial equivalence to a previously cleared device (DentalEye 2, K012439) based on intended use and technological characteristics, rather than presenting performance data from a clinical efficacy study.

    Here's what can be extracted regarding how the device meets the acceptance criteria (which, in this context, are primarily about substantial equivalence and safety standards):

    1. Acceptance Criteria and Reported Device Performance (Summary based on Substantial Equivalence Comparison):

    The "acceptance criteria" here are implicitly defined by the characteristics and performance of the predicate device (DentalEye 2, K012439) and compliance with safety standards. The study/justification provided is a comparison table and a statement of compliance.

    Acceptance Criterion (Implicit)Reported Device Performance (KaVo ERGOcom®/ERGOcam®)
    Intended Use: Acquiring, viewing, handling, and storage of dental color images and radiographs.Meets: "For acquiring, viewing, handling, and storage of dental color images and radiographs." (Identical to predicate)
    System Implementation: Software or Hardware/SoftwareMeets: Hardware and Software supplied (Predicate was software-only, but this is an enhancement, not a deviation from intended use)
    Host Platform: Intel or AMD PCMeets: PC Pentium, 1800 MHz or higher.
    Operating System: Windows 95/98/ME/2000/NTMeets: Windows 2000, Windows XP. And Microsoft .NET Framework.
    Host RAM: 32 MB minimumMeets/Exceeds: 256 MB
    Host Magnetic Storage: At least 500 MBMeets/Exceeds: Sufficient hard disk space to store imaging data., Usually 20 GB
    CD ROM: For installationMeets: Yes (for installation)
    Host Processor Speed: Pentium II 233 MHz or betterMeets/Exceeds: PC Pentium, 1800 MHz or higher.
    Host Monitor Size: Any VGA or better PC color monitorMeets/Exceeds: XGA or better, 15" or 19" Touch Display.
    Display Resolution: Minimum 800 X 600, Recommended 1024 X 768Meets/Exceeds: Screen resolution 1024 X 768, with min. true color depth (32 bit).
    User Display Preferences: YesMeets: Yes
    Receive Images from other Systems: YesMeets: Yes
    Images Displayed: Dental X-Rays, Intraoral Images, Extraoral ImagesMeets/Exceeds: Dental X-Rays, Intraoral Images, Extraoral Images (face, etc), Entertainment (TV) for patients, Instructional Video, Patient Administration.
    Safety Standards: (Predicate listed "Not applicable. Software only supplied.")Meets: UL/CSA standards for safety met. System has been thoroughly tested to IEC/UL/CSA standards including electrical safety and electromagnetic compatibility and has been found to comply with those standards.

    2. Study/Evidence Proving Acceptance:

    The "study" described is a comparative analysis for substantial equivalence to a predicate device (DentalEye 2, K012439) and testing for compliance with relevant safety standards.

    Key evidence provided:

    • Comparison Table: A detailed side-by-side comparison of the KaVo ERGOcom®/ERGOcam® system with the predicate device (DentalEye 2) across various technical and functional specifications.
    • Statement of Compliance: A declaration that the system has been "thoroughly tested to IEC/UL/CSA standards including electrical safety and electromagnetic compatibility and has been found to comply with those standards."
    • Conclusion of Substantial Equivalence: A statement that "In all important respects, the KaVo ERGOcom®/ERGOcam® Dental Image System is substantially equivalent to one or more predicate systems, including the one named above."

    Since this is a 510(k) submission primarily demonstrating substantial equivalence for an image management system without claims of diagnostic aid or advanced clinical performance, the following information is not applicable or not provided in the document:

    • Sample size for the test set and data provenance: No clinical test set data is presented for efficacy. The "test set" implicitly refers to the physical device undergoing safety and compatibility testing.
    • Number of experts and qualifications for ground truth: Not applicable for this type of submission focused on substantial equivalence of an image management system.
    • Adjudication method for the test set: Not applicable.
    • MRMC comparative effectiveness study: Not applicable, as no claims are made about human reader improvement with AI assistance.
    • Standalone (algorithm only) performance: Not applicable, as this is an image management system with human-in-the-loop operation.
    • Type of ground truth used: Not applicable for establishing clinical efficacy, as none is measured or reported.
    • Sample size for the training set: Not applicable, as this is not an AI/machine learning device with a "training set" in the typical sense.
    • How the ground truth for the training set was established: Not applicable.
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