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510(k) Data Aggregation

    K Number
    K042353
    Device Name
    AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS
    Manufacturer
    NATIONAL DISPLAY SYSTEMS
    Date Cleared
    2004-11-24

    (86 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K040310,K023340,K023322,K032202,K013922,K032638,K023341
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AXIS Radiology Monochrome Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The AXIS 5MP display is currently not cleared in the U.S. for use with Full Field Digital Mammography (FFDM). The AXIS 1MP, 2MP and 3MP displays are not intended for use with FFDM.

    Device Description

    The AXIS Monochrome Display is a diagnostic display. The AXIS Monochrome Display is a high resolution, Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images.

    AI/ML Overview

    This 510(k) pertains to monochrome medical display monitors and therefore doesn't involve a study with acceptance criteria in the typical sense of algorithm performance. The FDA clearance is based on substantial equivalence to predicate devices. This means the new device (AXIS I, II, III, and V Monochrome Displays) has the same intended use and technological characteristics as already legally marketed devices, and they do not raise new questions of safety or effectiveness.

    Therefore, many of the typical questions for AI/algorithm-based devices (like sample sizes, ground truth establishment, MRMC studies) are not applicable here.

    Here's a breakdown of what can be extracted and how it relates to acceptance criteria in this context:

    1. Table of Acceptance Criteria and Reported Device Performance:

    For a display device, "acceptance criteria" primarily revolve around demonstrating performance similar to predicate devices and meeting relevant display standards. The document doesn't provide specific numerical performance metrics for the AXIS displays, but rather establishes equivalence to predicate devices.

    Acceptance Criterion (Implicit)Reported Device Performance (Reference to Predicate)
    Intended Use Equivalence: The display must be suitable for displaying and viewing digital medical images for review and analysis by trained medical practitioners.Met: Explicitly stated as intended use. Proven by substantial equivalence to predicate devices with the same intended use.
    Technological Equivalence: The display must have similar technological characteristics (e.g., resolution, display type) to legally marketed devices.Met: The AXIS displays are described as "high resolution, Liquid Crystal Display (LCD) with electronic capabilities." Substantial equivalence is claimed for various resolutions (1MP, 2MP, 3MP, 5MP) to corresponding predicate devices.
    Safety and Effectiveness Equivalence: The device must not raise new questions of safety or effectiveness compared to predicate devices.Met: The FDA's substantial equivalence determination implies that no new safety or effectiveness concerns were identified compared to the predicate devices.
    Limitations of Use: Adherence to existing limitations for similar devices (e.g., FFDM use).Met: Clearly states that the AXIS 5MP is not cleared for FFDM in the U.S., and the 1MP, 2MP, and 3MP displays are not intended for use with FFDM, mirroring predicates or current regulations.

    2. Sample Sizes and Data Provenance:

    • Test Set Sample Size: Not applicable. There was no specific "test set" of medical images or patient data used to evaluate the device's diagnostic performance in a clinical study. The evaluation is based on technical specifications and comparison to predicate devices.
    • Data Provenance: Not applicable.

    3. Number of Experts and Qualifications for Ground Truth:

    • Not applicable. Ground truth, in the sense of expert consensus on medical findings, is not relevant for the substantial equivalence of a display monitor. The evaluation focuses on the technical specifications and intended use of the display itself, not its impact on diagnostic accuracy, which is presumed to be equivalent to the predicate devices.

    4. Adjudication Method:

    • Not applicable.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • No. An MRMC study was not done. These studies are typically conducted for AI algorithms or new diagnostic methodologies to assess their impact on human reader performance. For a display device, the focus is on its technical specifications and equivalence, not its direct impact on reader performance beyond providing a clear image comparable to existing displays.

    6. Standalone Performance Study:

    • No. A standalone algorithm performance study was not done because this is a hardware device (a display monitor), not an algorithm or AI system. Its "performance" is inherently tied to its technical specifications and its ability to display images, which is assumed to be equivalent to the predicate devices.

    7. Type of Ground Truth Used:

    • Not applicable. The "ground truth" for this submission is the technical specifications and regulatory status of the predicate devices. The new device's compliance with similar specifications and its intended use form the basis for its clearance.

    8. Sample Size for the Training Set:

    • Not applicable. The AXIS Monochrome Display is a hardware device; it does not involve machine learning or an algorithm that requires a training set.

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

    • Not applicable.

    In summary: This 510(k) is a typical substantial equivalence submission for a medical display device. The "acceptance criteria" are implicitly met by demonstrating that the new device shares the same intended use and similar technological characteristics to already cleared predicate devices, without raising new concerns about safety or effectiveness. Clinical performance studies are not required for this type of submission.

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