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510(k) Data Aggregation

    K Number
    K171681
    Device Name
    Hermes Medical Imaging Suite v5.7
    Manufacturer
    Hermes Medical Solutions AB
    Date Cleared
    2017-11-21

    (168 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K153056,K130884
    Why did this record match?
    Device Name :

    Hermes Medical Imaging Suite v5.7

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

    HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

    Device Description

    The base product design of Hermes Medical Imaging Suite v5.7 is the same as for the Hermes Medical Imaging Suite v5.6 (K153056). The following modules have been added in this applicatio to Hybrid Viewer NM Processing: Colonic Transit, Remnant Liver, Parathyroid, Dosimetry, Classic DMSA, Oesophageal Transit/Reflux, HIDA, Salivary Gland, Bone3Phase Analysis and Uniformity.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study details for the Hermes Medical Imaging Suite v5.7:

    Understanding the Device:

    The device, HERMES Medical Imaging Suite v5.7, is a software application suite for processing, displaying, analyzing, and managing nuclear medicine and other medical imaging data. It has added several new modules compared to its predecessor (v5.6).

    Challenges in Extracting Information:

    The provided text is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to a predicate device. It doesn't present a traditional "acceptance criteria" table or a single, comprehensive study report with detailed methodologies. Instead, it describes a series of comparative tests against predicate devices and manual calculations. Therefore, the "acceptance criteria" are implied by the comparisons and the statement that "the testing results supports that all the software specifications have met the acceptance criteria." The reported performance is the outcome of these comparisons.

    1. Table of Acceptance Criteria and Reported Device Performance

    Module/Function TestedAcceptance Criteria (Implied)Reported Device Performance
    Hybrid Recon (Myocardial SPECT)High correlation (Pearson correlation coefficient r close to 1) with predicate v5.6 for QPS parameters (SSS, Stress volume, Stress Area, Stress Defect Area, SRS, Rest Volume, Rest Area, Rest Defect Area).Pearson correlation coefficient r between 0.96 to 0.99 with Hybrid Recon in Medical Imaging Suite v5.6.
    Hybrid Recon (Phantom Studies)Similar accuracy in activity concentration calculation to predicate v5.6, particularly for larger targets.Jaszczak Phantom: Average error between reconstructed and true activity concentration: -3.5% with v5.6, -1.1% with v5.7.
    IEC Phantom: Error of reconstructed activity concentration around 5% for large enough targets; reduced accuracy in small targets due to partial volume effect (as expected).
    Classic DMSAMaximum percentage difference in relative function values with predicate v5.3's Classic DMSA application should be small.Maximum % difference between Classic DMSA in v5.7 and Classic DMSA in v5.3 for relative function values is **
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