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510(k) Data Aggregation

    K Number
    K223546
    Device Name
    14HQ721G-B
    Date Cleared
    2023-01-27

    (63 days)

    Product Code
    Regulation Number
    892.1680
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    14HQ721G-B

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

    The Flat Panel Digital X-ray Detector 14HQ721G-B is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

    Device Description

    This model is an x-ray imaging device, a system that can acquire and process X-ray images as digital images. It utilizes amorphous silicon and a high-performance scintillator to ensure sharp highdefinition image quality with the resolution of 3.6 lp/mm and the pixel pitches of 140 um. This device is a flat panel based X-ray image acquisition device. This device must be used in conjunction with an operating PC and an X-ray qenerator. This device can be used for digitizing and transferring X-ray images for radiological diagnosis. The data transmission between the Detector and PC can be enabled with a wired (cable) or wireless connection. This device does not have a dynamic exposure feature.

    AI/ML Overview

    This document describes the LG Electronics Inc. Flat Panel Digital X-ray Detector 14HQ721G-B. The information provided outlines the device's acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Predicate Device K221394)Reported Device Performance (14HQ721G-B)
    ScintillatorCsICsI
    Imaging Area14 x 17 inches14 x 17 inches
    Pixel Matrix2,500 x 3,052 pixels2,500 x 3,052 pixels
    Pixel Pitch140 um140 um
    High Contrast Limiting Resolution3.6 lp/mm3.6 lp/mm
    CommunicationWired/WirelessWired/Wireless (Standard: 802.11 a/b/g/n/ac compliance, Frequency: 2.4 GHz/5GHz, Bandwidth: 20MHz/40MHz/80MHz, MIMO: 2x2)
    DQE (Detective Quantum Efficiency)Typ. 66% @ 0.1 lp/mmTyp. 66% @ 0.1 lp/mm
    MTF (Modulation Transfer Function)Typ. 84% @ 0.5 lp/mmTyp. 84% @ 0.5 lp/mm
    Resolution3.6 lp3.6 lp
    Anatomical SitesGeneralGeneral
    Exposure ModeManual, Auto (AED)Manual, Auto (AED)
    Built-in AECX (Not present)O (Present)
    Semi Dynamic modeO (Present)O (Present)
    Rating24V --- 2.1A24V --- 2.1A
    Electrical Safety, EMC, & PerformanceCompliance with relevant standardsComplies with ES60601-1:2005 (R)2012 & A1:2012 [Incl. AMD2:2021], IEC 60601-1-2 Edition 4.0 2014-02, FDA guidance "Radio Frequency Wireless Technology in Medical Devices", FDA guidance "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices"
    Software ValidationVerified and ValidatedSoftware designed and developed according to internal process, verified and validated according to FDA guidance "The content of premarket submissions for software contained in medical devices"
    BiocompatibilityCompliance with ISO 10993-1Complies with ISO 10993-1 and series
    Imaging Performance TestConducted according to IEC 62220-1-1Conducted according to IEC 62220-1-1
    CybersecurityCompliance with FDA guidanceComplies with FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and "Postmarket Management of Cybersecurity in Medical Devices"
    LabelingCompliance with CFR Part 801Complies with CFR Part 801, and FDA guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications"

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

    The document explicitly states: "In this submission, clinical testing was not conducted, since nonclinical information is sufficient to show the substantial equivalence of the proposed devices to the predicate devices for the modifications." This implies that there was no specific "test set" of patient data for clinical performance evaluation. The substantial equivalence was primarily based on non-clinical engineering and performance testing comparing the proposed device to the predicate device.

    Therefore, information on sample size, country of origin, and retrospective/prospective nature of a clinical test set is not applicable as no clinical test set was used for this submission's substantial equivalence demonstration.

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

    Not applicable, as no clinical test set was used to establish ground truth for this submission.

    4. Adjudication Method for the Test Set

    Not applicable, as no clinical test set was used.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

    No MRMC comparative effectiveness study was conducted as clinical testing was not performed. The submission relies on non-clinical data to demonstrate substantial equivalence.

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

    The device itself is a Flat Panel Digital X-ray Detector, which is a hardware component for acquiring X-ray images. It includes firmware (software of moderate level of concern) that was validated. The performance tests (DQE, MTF, resolution) are measures of the standalone imaging capabilities of the device itself, without a human in the loop for interpretation beyond assessing image quality metrics. The comparison of these metrics to the predicate device effectively serves as a standalone performance assessment.

    7. The Type of Ground Truth Used

    The ground truth for performance was established through objective engineering and physical measurements based on established standards (e.g., IEC 62220-1-1 for DQE) and comparison to the predicate device's specifications. This is a technical ground truth for imaging performance rather than a clinical ground truth based on expert consensus, pathology, or outcomes data from patients.

    8. The Sample Size for the Training Set

    The document does not provide information on a training set size. This is consistent with the nature of the device being a digital X-ray detector, where performance is typically validated through engineering tests and comparison to a predicate, rather than through a machine learning model that requires a "training set" of data in the conventional sense. The "software update" mentioned includes the addition of the AEC mode, and this software was designed, developed, verified, and validated internally, but no specific training data for an AI algorithm is indicated.

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

    Not applicable, as no training set for a machine learning model is described. The ground truth for the device's technical performance was established through standardized physical measurements and component specifications, as detailed in point 7.

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