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    K Number
    K102327
    Device Name
    CLEARVISION DR 7000F
    Manufacturer
    JPI HEALTHCARE CO., LTD
    Date Cleared
    2012-04-13

    (605 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K090742,K102587,K083640
    Why did this record match?
    Device Name :

    CLEARVISION DR 7000F

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

    The Clear Vision DR7000F product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column,. chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

    The Clear Vision DR7000F system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.

    Device Description

    The Clear Vision DR7000F system is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of a tube head/collimator assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software.

    The detector which is used proposed device is LTX240AA01-A (K090742) and LLX240AB01 (K102587) of Samsung Mobile Display Co., Ltd. These detectors are cleared by FDA 510(k).

    AI/ML Overview

    The provided 510(k) summary for the Clear Vision DR7000F does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or algorithm-only performance.

    The document describes a digital radiography X-ray system, which is a hardware device, not an AI or algorithm-based diagnostic tool. The submission focuses on demonstrating substantial equivalence to predicate hardware devices and compliance with electrical, mechanical, environmental safety, and performance standards for X-ray systems.

    Therefore, most of the requested information regarding AI/algorithm performance, ground truth establishment, expert review, and training/test set sizes is not applicable to this document.

    Here's a breakdown of what can be extracted or inferred from the provided text, and where information is missing / not applicable:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Electrical, Mechanical, Environmental Safety & Performance: Compliant with EN/IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32.All test results were satisfactory.
    EMC: Compliant with EN/IEC 60601-1-2(2007).Testing was conducted in accordance with standard EN/IEC 60601-1-2(2007). All test results were satisfactory.
    X-ray Detector Performance: Not explicitly stated as a separate criterion, but performance and clinical testing were provided as recommended by FDA guidance for Solid State X-ray Imaging Devices.Performance and clinical testing for the X-ray detectors were provided. (The document indicates the detectors LTX240AA01-A and LLX240AB01 were previously cleared by FDA 510(k), implying their performance was acceptable.)
    Substantial Equivalence: To predicate devices CDX-DR80D (Choongwae Medical Corp.) and LTX240AA01-A, LLX240AB01 (Samsung Mobile Display Co. Ltd.).The conclusion states the device is substantially equivalent to the predicate devices, implying it meets the necessary performance and safety profiles.

    Regarding specific questions related to AI/Algorithm performance:

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

    • Not applicable / Not provided. This device is an X-ray imaging system, not an AI algorithm. The "clinical testing" mentioned for the X-ray detectors likely refers to performance evaluation under clinical conditions, not an algorithm's diagnostic accuracy on a test set of images.

    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 / Not provided. No specific "ground truth" establishment for an algorithm's performance is mentioned. Evaluation of an X-ray system focuses on image quality, radiation dose, safety, and functionality, which are assessed against technical specifications and clinical utility, rather than diagnostic "ground truth" for an AI model.

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

    • 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

    • Not applicable / Not provided. This submission is for a medical imaging device, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

    • Not applicable / Not provided. No standalone algorithm performance is discussed.

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

    • Not applicable / Not provided. For an X-ray device, "ground truth" generally relates to physical measurements (e.g., spatial resolution, contrast-to-noise ratio, MTF, DQE) and clinical image quality (diagnostic acceptability) rather than a pathology reference for an AI diagnosis.

    8. The sample size for the training set

    • Not applicable / Not provided. No AI training set is mentioned.

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

    • Not applicable / Not provided. No AI training is mentioned.

    Summary regarding the device:

    The Clear Vision DR7000F is a digital radiography X-ray system. The study proving it meets acceptance criteria primarily involves engineering and performance testing against established international standards (EN/IEC 60601 series) for medical electrical equipment, as well as specific guidance for solid-state X-ray imaging devices. The acceptance criteria relate to electrical, mechanical, environmental safety, electromagnetic compatibility (EMC), and the technical performance and clinical utility of the X-ray detectors. The "study" mentioned is the compilation of these satisfactory test results conducted by the manufacturer, demonstrating compliance and substantial equivalence to existing cleared predicate hardware devices.

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