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510(k) Data Aggregation

    K Number
    K191262
    Device Name
    aBSI
    Manufacturer
    EXINI Diagnostics AB
    Date Cleared
    2019-08-05

    (87 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K122205
    Why did this record match?
    Reference Devices :

    K122205

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

    aBSI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images acquired using nuclear medicine (NM) imaging. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including lesion marking and quantitative analysis.

    Device Description

    The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient's skeletal disease on a bone scan, as the fraction of the total skeleton weight. The user of this product is typically a health-care professional using the software to view the patient images and analysis results.

    AI/ML Overview

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

    Acceptance Criteria and Device Performance

    The document doesn't explicitly define a table of "acceptance criteria" with specific performance thresholds. Instead, it refers to the device's performance through verification testing and clinical studies, demonstrating its ability to quantify the Bone Scan Index (BSI) and its association with clinical outcomes.

    However, based on the performance data presented, here's an inferred table of performance aspects and reported findings:

    Performance AspectReported Device Performance
    BSI Calculation Linearity & AccuracyDemonstrated during analytical validation studies. (Specific metrics not provided in the summary, but implied to be acceptable.)
    BSI Calculation PrecisionDemonstrated during analytical validation studies. (Specific metrics not provided in the summary, but implied to be acceptable.)
    Reproducibility (different cameras)Demonstrated during analytical validation studies. (Specific metrics not provided in the summary, but implied to be acceptable.)
    Reproducibility (multiple images)Demonstrated during analytical validation studies. (Specific metrics not provided in the summary, but implied to be acceptable.)
    Reproducibility (repeated bone scans)Demonstrated during patient study. (Specific metrics not provided in the summary, but implied to be acceptable.)
    Hotspot Detection Algorithm ImprovementImproved algorithm from predicate. Clinical performance testing demonstrated "substantially equivalent performance" to the predicate, implying improvement while maintaining equivalence.
    Association with Overall Survival (Study I)Automated BSI (median=1.07; range: 0-32.60) was significantly associated with OS (HR:1.20; 95%CI:1.14-1.26; P
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