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510(k) Data Aggregation

    K Number
    K061018
    Device Name
    PLANAR DOME EX LINE MODEL DOME E2C
    Manufacturer
    PLANAR SYSTEMS, INC.
    Date Cleared
    2006-04-28

    (15 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K052352
    Why did this record match?
    Device Name :

    PLANAR DOME EX LINE MODEL DOME E2C

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

    The Planar Dome® EX line Model Dome® E2c is intended to be used in displaying and viewing digital medical images for review, analysis, and diagnosis by trained medical practitioners.

    This device must not be used in primary image diagnosis in mammography.

    Device Description

    The Planar Dome® EX line Model Dome® E2c is a flat panel hi-resolution AMLCD monitor system for displaying medical images. The system consists of an AMLCD monitor and a high-resolution graphic control board that connects to a PACS workstation for image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images. CXtra is user-friendly software, the purpose of which is to optimize the display for DICOM-compliant viewing.

    AI/ML Overview

    The provided text is a 510(k) Summary for the Planar Dome® EX line Model Dome® E2c, which is a medical image display system. The document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a clinical performance study would.

    Instead, the summary states that the device "has been tested to various Standards and was validated for its intended use" and that "Performance attributes are similar" to the predicate device. It also mentions that the device will "Follow DICOM PS3.14 'Grayscale Standard Display Function'". This implies that the acceptance criteria are related to compliance with these standards and similar performance to the predicate, rather than clinical efficacy metrics typical of AI/CAD devices.

    Given the information, I will interpret "acceptance criteria" as the performance attributes and standards the device aims to meet.

    Here's the breakdown of the information that can be extracted or reasonably inferred from the provided document, addressing your points:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Implied)Reported Device Performance
    Compliance with DICOM PS3.14 "Grayscale Standard Display Function""Follow DICOM PS3.14 'Grayscale Standard Display Function'"
    Performance attributes similar to predicate BARCOView, Color Coronis 2MP-21" (K052352)"Performance attributes are similar"
    Intended use is same as predicate device"Intended use is same"
    Validated for its intended use"was validated for its intended use"
    Manufactured in accordance with voluntary and safety standards"will be manufactured in accordance with voluntary and safety standards"
    Hazard analysis classifies potential hazards as Minor"potential hazards have been classified as Minor"

    2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

    The document does not describe a clinical study with a "test set" in the context of comparing algorithm performance on medical images. The device is a display monitor. The "testing" mentioned refers to compliance with standards and validation of the display system's functionality. Therefore, information on sample size or data provenance is not applicable and not provided.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

    Not applicable. As a display device, there is no "ground truth" to be established by experts for image interpretation in this context. The device's performance is likely evaluated against technical specifications and display standards.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

    Not applicable, as there is no test set for clinical interpretation.

    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

    No MRMC study was done. This device is a display monitor and does not incorporate AI or provide assistance to human readers in the way an AI/CAD system would. Its primary function is to render images accurately.

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

    Not applicable. This is a display device, not an algorithm.

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

    Not applicable. The "ground truth" for a display device would relate to its technical specifications and adherence to display standards (e.g., DICOM grayscale display function), which are measured objectively using calibrated equipment.

    8. The sample size for the training set

    Not applicable. This device is a hardware display system, not a machine learning model.

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

    Not applicable. This device is a hardware display system, not a machine learning model.

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