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510(k) Data Aggregation

    K Number
    K193360
    Device Name
    Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
    Manufacturer
    Radmedix LLC
    Date Cleared
    2020-01-02

    (29 days)

    Product Code
    KPR,MQB
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K151942,K142475,K162552,K162555,K171137,K193017,K152172,K141440,K180332,K182348,K183286,K183713,K183422,K182550,K182551,K161730,K160620
    Why did this record match?
    Reference Devices :

    K142475, K162552, K162555, K171137, K193017, K152172, K141440, K180332, K182348, K183286, K183713, K183422

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

    The purpose of Acuity is to acquire, store, communicate, display and process medical X-ray images. These radiographic systems are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography, angiography, interventional, or fluoroscopy use.

    Device Description

    RadmediX Acuity combines components into a complete stationary x-ray system, including software, tube stands, tube heads, collimators, generators, tables, and digital radiography panels.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information based on the provided text:

    Acceptance Criteria and Device Performance:

    The document describes the Acuity SDR Standard, Acuity SDR Plus, and Acuity FDR Standard as stationary x-ray systems. The core claim for substantial equivalence is that the device performs the same functions using the same technological methods as the predicate device (Visaris Vision®) to produce diagnostic x-ray images.

    Feature / CriterionAcceptance Criteria (Implied by Predicate Equivalence)Reported Device Performance (Acuity Systems)
    Indications for UseAcquisition, storage, communication, display, and processing of medical X-ray images for diagnostic X-rays on adult and pediatric subjects. Not for mammography, angiography, interventional, or fluoroscopy use.Identical to predicate.
    Wall Stand FunctionalityMotorized vertical movable wall stand, tiltable tray."SAME" – Equivalent Functionality.
    Table FunctionalityFree-floating and height-adjustable, maximum patient weight 660 lbs., working table height 20-5/16 inch to 37-5/8 inch."SAME" – Equivalent Functionality.
    X-ray Tube Specifications150 kVp 0.6/1.2mm focal spots (Toshiba)."SAME" – Equivalent Functionality.
    Collimator CertificationAll CFR Certified. (510(k) exempt)Collimaire collimators, all CFR Certified. (510(k) exempt) – Equivalent Functionality.
    X-ray Generator Types and CertificationVarious HF Models (Claymount up to 63 kW, CPI 32kW to 100kW, EMD 45 kW to 80 kW, POSKOM 32 kW to 50 kW, Sedecal 40, 50, 65, or 80 kW), all CFR Certified.Various HF Models (Summit 40 to 50 kW, CPI up to 80 kW), all CFR Certified. (510(k) exempt) – Equivalent Functionality.
    Wireless Detector CapabilityUses FDA cleared 14" x 17" detectors and software (e.g., Pixium 3543 EZ C).Optional enclosure for 14" x 17" fixed and removable FDA cleared detectors and software. – Equivalent Functionality.
    Fixed Detector CapabilityUses FDA cleared 17"x17" detectors and software (e.g., Pixium 4343RC).Uses FDA cleared 17"x17" detectors and software. – Equivalent Functionality. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Compatibility with Conventional Film/CR CassettesComes with FDA cleared digital x-ray panels, but conventional film and CR cassettes can still be used."SAME" – Similar Functionality. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Operator Console InterfaceGUI-based."SAME" – Similar Functionality. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Acquisition SoftwareFDA cleared digital x-ray acquisition software (e.g., Visaris Avanse, K150725).Customer selects AccuVueMED (K152172) or AccuVue (K141440). Only cleared software is supplied. – Equivalent Functionality. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Power SourceAC LINE, single or three phase depending on the generator."SAME" – SAME. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Compliance with StandardsIEC 60601-1:2005 (Basic Safety and Essential Performance), IEC 60601-1-2:2014 (Electromagnetic Disturbances), IEC 60601-2-54 Ed 1.0 (X-Ray Equipment for Radiography and Radioscopy), NEMA PS 3.1 - 3.20 (2011) DICOM Set, 21CFR1020 (Electronic Products; Performance Standard for Diagnostic X-Ray Systems). Component certification by manufacturers."SAME" – Generators are UL Listed. Components certified by manufacturers. Software used unmodified from previous FDA clearances. – SAME. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Image Quality (Clinical Acceptability)Produce images of high quality and contrast, clinically acceptable for diagnostic x-rays across various anatomical regions.A constructed and field-tested complete system (AcuitySDR with specific components) acquired DICOM images from all major body structures, all images were of high quality and contrast and clinically acceptable. Each new configuration undergoes a digital image integration protocol and a total system validation protocol prior to ensure the configuration works as intended. "The flat-panel detectors used with the x-ray system Acuity present comparable or better performance than the predicate detectors."
    CybersecurityManaged as per FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff October 2014".Updated internal standard operating procedures and added cybersecurity precautions to software users' manuals. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Pediatric Considerations in User ManualsIncluded in user manuals.Generator User Manuals have been updated to add Pediatric Considerations. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Study Information:

    1. Sample Size and Data Provenance:

      • Test Set Sample Size: Not explicitly stated as a numerical sample size of clinical cases for a formal clinical trial. Instead, the non-clinical testing involved acquiring DICOM images from "all major body structures" using one AcuitySDR system configuration.
      • Data Provenance: The document does not specify the country of origin for the image acquisition or whether it was retrospective or prospective. It was a "field tested" system, implying real-world or simulated real-world scenarios.

    2. Number of Experts and Qualifications (for Ground Truth):

      • Number of Experts: Not specified.
      • Qualifications of Experts: Not specified, beyond the statement that images were generated for "diagnostic x-rays" and assessed as "clinically acceptable." This implies evaluation by trained personnel (e.g., radiologic technologists, radiologists), but their specific qualifications or number are not detailed.

    3. Adjudication Method:

      • No formal adjudication method is described. The assessment of image quality was based on whether images were "of high quality and contrast and clinically acceptable."

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

      • No MRMC comparative effectiveness study was performed or described. The submission focuses on demonstrating substantial equivalence through technical characteristics and non-clinical image quality assessment, not on human reader performance improvement with or without AI assistance.

    5. Standalone Performance Study (Algorithm Only):

      • Yes, a standalone study (non-clinical testing) was performed. The algorithm (software) alongside the hardware components was tested to acquire and process images. The output (DICOM images) was then evaluated for inherent quality and acceptability. The assessment "all images were of high quality and contrast and clinically acceptable" refers to the output of the integrated system.

    6. Type of Ground Truth Used:

      • Expert Consensus / Clinical Acceptability: The ground truth for image quality was established through subjective expert assessment of "high quality and contrast and clinically acceptable." It does not mention pathology or outcomes data.

    7. Training Set Sample Size:

      • Not applicable. This device is an X-ray system, not an AI/ML algorithm that requires a training set in the typical sense for image interpretation or diagnosis. The "software" components mentioned (AccuVueMED, AccuVue) are image acquisition and processing software, which are generally deterministic and not "trained" on data in the way a diagnostic AI would be. They are "previously cleared software supplied with the system."

    8. How Ground Truth for Training Set Was Established:

      • Not applicable, as there is no specific "training set" for an AI/ML algorithm in this submission. The software components were previously cleared by the FDA, implying their performance was established through other means at the time of their original clearance (K152172 and K141440).
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