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510(k) Data Aggregation

    K Number
    K052352
    Device Name
    COLOR CORONIS 2MP-21 AND MFCD 2321
    Manufacturer
    BARCOVIEW
    Date Cleared
    2005-09-30

    (32 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K040365,K040158
    Why did this record match?
    Device Name :

    COLOR CORONIS 2MP-21 AND MFCD 2321

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

    The Color Coronis 2MP-21" is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

    The MFCD 2321 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

    Device Description

    Color Coronis 2MP-21" is a display system for medical viewing. It consists of 3 components: MFCD 2321 is a 21.3" color LCD display. BarcoMed 2MP2CF-e is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal Pro is user-friendly softcopy QA software. The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.

    MFCD 2321 is a 21.3" color LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.

    AI/ML Overview

    This 510(k) submission describes two medical display systems, the Color Coronis 2MP-21" and the MFCD 2321. Both are intended for displaying and viewing digital images for review by trained medical practitioners, specifically excluding primary image diagnosis in mammography.

    The submission is a claim of substantial equivalence to predicate devices (Color Coronis 2MP medical flat panel display system for the Color Coronis 2MP-21", and MFCD 2320 for the MFCD 2321). This means the manufacturer is asserting that the new devices are as safe and effective as existing legally marketed devices, rather than presenting a study demonstrating new performance characteristics against specific acceptance criteria.

    Therefore, the provided document does not contain information regarding traditional acceptance criteria or a study that proves the device meets specific performance criteria in the way an AI/CADe device submission would. Instead, the "proof" is the demonstration of substantial equivalence to already cleared devices.

    Here's why the requested information cannot be fully provided based on the input:

    • No specific acceptance criteria are listed for the new devices' performance. The "acceptance criteria" here is implicitly "be substantially equivalent to the predicate device."
    • No new performance study focused on diagnostic accuracy or clinical outcomes was conducted. The studies would have been the original validation studies for the predicate devices.
    • No AI/CADe components are described. The devices are display systems.

    However, I can extract the relevant information about the equivalence claim and the limited testing mentioned:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implicit for equivalence)Reported Device Performance (as claimed for substantial equivalence)
    Color Coronis 2MP-21"
    Substantially equivalent to predicate device (Color Coronis 2MP medical flat panel display system) in technical characteristics, general function, application, and intended use."The Barco Color Coronis 2MP-21" is substantially equivalent to the predicate device, Color Coronis 2MP medical flat panel display system. The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy."
    MFCD 2321
    Substantially equivalent to predicate device (MFCD 2320) in technical characteristics, general function, application, and intended use. (Implied, similar to above)"The Barco MFCD 2321 is substantially equivalent to the predicate device, MFCD 2320. The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference between both devices does not affect safety or efficacy." (Note: The provided text for MFCD 2321 specifically omits the "technical characteristics" phrase in the conclusion, but it's logically implied from the preceding discussion)
    Specific Performance Parameters (for the components, compared to predicate) (e.g., resolution, color depth, QA software functionality)**Color Coronis 2MP-21":**MFCD 2321 display: 1600x1200 pixels resolution, landscape/portrait mode. BarcoMed 2MP2CF-e board: 32-bit in/out LUT, 24-bit color depth (16 million colors). MediCal Pro software: automated image QA, display viewing performance maintenance/logging, QA task automation, system calibration. Comparison: Different display controller board and a different LCD panel with a "somewhat larger screen size" compared to predicate. Other components same. MFCD 2321 (standalone display): 1600x1200 pixels resolution, landscape/portrait mode. MediCal Pro software: automated image QA, maintains/logs display viewing performance, automates QA, sets up calibration. Comparison: Different LCD panel with a "somewhat larger screen size" compared to predicate.

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

    • This information is not applicable / not provided in a traditional sense. These submissions are for medical display systems, not devices that process image data for diagnostic findings. Therefore, there are no "test sets" of patient data or data provenance of that nature described. The testing would revolve around the technical specifications and functionality of the display and its components.

    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 / not provided. As explained above, no test set requiring expert ground truth is described.

    4. Adjudication method for the test set

    • This information is not applicable / not provided.

    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

    • This information is not applicable / not provided. There is no AI component in these display systems, and no MRMC study is described. The devices are for viewing images by human practitioners, not for AI-assisted interpretation.

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

    • This information is not applicable / not provided. These are display systems, not algorithms.

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

    • This information is not applicable / not provided.

    8. The sample size for the training set

    • This information is not applicable / not provided. These devices do not use machine learning algorithms that require training sets.

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

    • This information is not applicable / not provided.
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