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510(k) Data Aggregation

    K Number
    K112670
    Device Name
    DX-D 600
    Manufacturer
    AGFA HEALTHCARE N.V.
    Date Cleared
    2011-10-27

    (43 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K051901,K103050
    Why did this record match?
    Device Name :

    DX-D 600

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

    The DX-D 600 system is indicated to make static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts.

    Applications can be performed with the patient in the sitting, standing or lying position.

    This device is not intended for use in mammography.

    Device Description

    The device is a conventional x-ray system with digital image capture equipment. The device is a combination of conventional x-ray system with and/or wall stand. The new device is a ceiling mounted tube and operator workstation with MUSICA 2TM image processing. The DX-D 600 uses Agfa's digital flat panel detectors of the scintillator-photodetector type (Cesium Iodide on Gadolinium Oxysulfide). It is compatible with Agfa's computed radiography systems as well.

    AI/ML Overview

    The Agfa DX-D 600 is a stationary X-ray system. The 510(k) summary states that "An image quality evaluation has been conducted comparing images from the new device to the predicated [sic]." and "Performance of the complete system has been validated." However, no specific quantitative acceptance criteria or detailed study results are provided in the document.

    Here's an overview based on the provided text, highlighting the limited information available:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Stated/Inferred)Reported Device Performance
    Image Quality Evaluation: Comparison of images from the new device to the predicate device. (Implied acceptance if found comparable)"An image quality evaluation has been conducted comparing images from the new device to the predicated." (No quantitative results provided)
    System Performance Validation: Complete system validated. (Implied acceptance if found valid)"Performance of the complete system has been validated." (No specific metrics or results provided)
    Compliance with Product Standards: Meeting various IEC, DICOM, and CFR standards.The product was "tested and shown to conform to electronic medical product safety, radiology, and medical imaging standards." (Specific standards listed include IEC 60601-1, IEC 60601-1-2, ACR/NEMA PS3.1-3.18 (DICOM), IEC 60601-1-3, and 21CFR1020.30).
    Compliance with Management Standards: Adherence to risk management and quality management systems.The product was tested and shown to conform to ISO 14971 and ISO 13485.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not provide details on the sample size used for any image quality evaluation or system performance validation. It also does not mention the country of origin of the data or whether the study was retrospective or prospective.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not provided in the document.

    4. Adjudication Method for the Test Set

    This information is not provided in the document.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No MRMC study is mentioned. The comparison focuses on the new device's images against those from a predicate device, which usually implies an engineering or technical comparison rather than a human reader study.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    The device is an X-ray system, not an AI algorithm for image analysis. Therefore, a standalone algorithm performance study, as typically understood in the context of AI, would not be applicable here. The "image processing" mentioned is MUSICA 2™ which is an established image processing technology for optimizing image quality, not a diagnostic AI algorithm.

    7. The Type of Ground Truth Used

    The document does not specify the type of ground truth used for any evaluations. Given the comparison is to a "predicated" [sic] device, the implicit ground truth for image quality likely relates to the accepted image quality standards or diagnostic utility achievable with the predicate device. It's not clear if this involved expert consensus, pathology, or outcomes data.

    8. The Sample Size for the Training Set

    The device is a conventional X-ray system with digital image capture and image processing. It is not an AI-based diagnostic device that typically requires a "training set" in the machine learning sense. The image processing (MUSICA 2™) is a pre-existing technology.

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

    As above, the concept of a "training set" and associated ground truth establishment is not applicable to the Agfa DX-D 600 as described in this 510(k) summary.

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