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    K Number
    K233249
    Device Name
    APPRAISE-HRI
    Manufacturer
    The Surgeon General, Department of the Army (TSG-DA)
    Date Cleared
    2024-04-05

    (190 days)

    Product Code
    SAR
    Regulation Number
    870.2220
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K202375
    Why did this record match?
    Applicant Name (Manufacturer) :

    The Surgeon General, Department of the Army (TSG-DA)

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

    The APPRAISE-HRI is a mobile health app intended to provide a means for military healthcare providers to screen U.S. Service members for hemorrhage risk after a physically traumatic event and stratify casualties who need immediate attention and emergency evacuation from those who are injured but may not be at risk for hemorrhage.

    The APPRAISE-HRI is not intended to diagnose or direct treatment. Rather, it is intended to provide situational awareness and inform clinical management of potentially hemorrhagic casualties by identifying those at the greatest risk of hemorrhage.

    Device Description

    The Automated Processing of the Physiological Registry for Assessment of Injury Severity (APPRAISE)-Hemorrhage Risk Index (HRI) is an Android application developed by the U.S. Army Medical Research and Development Command (USAMRDC) that uses vital-sign data collected from a trauma patient to provide a risk score that stratifies the patient's risk of hemorrhage. When the application runs, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) vital-sign data are collected from an external monitor [currently only the ZOLL Propaq M (K202375) is supported]. The ZOLL Propaq M monitor connects via Bluetooth with the Android platform running the APPRAISE-HRI application. The APPRAISE-HRI application continuously pulls data from the ZOLL Propaq M monitor to gather the required vital signs (HR, SBP, and DBP) and then runs the hemorrhage risk stratification algorithm to generate an output every one minute.

    Once the vital-sign data from the ZOLL Propaq M monitor are transferred, the APPRAISE-HRI provides a stratification of hemorrhage into three Risk Level categories: Low (I), Average (II), or High (II). The APPRAISE-HRI application continuously displays both the input vital signs (HR, SBP, and DBP) and the Risk Level score to the caregiver to provide situational awareness and to inform clinical management of potentially hemorrhagic casualties by identifying those at the greatest risk of hemorrhage.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study details for the APPRAISE-HRI device, based on the provided document:

    Acceptance Criteria and Device Performance

    Acceptance CriterionReported Device Performance (Likelihood Ratio [95% CI])Interpretation
    HRI Level I Effectiveness$\leq$ 0.20 (at least 5 times less likely for hemorrhage patients)0.18 [0.12, 0.26]
    HRI Level II EffectivenessValue close to 1 (almost as likely for hemorrhage patients as for control patients)0.70 [0.63, 0.76]
    HRI Level III Effectiveness$\geq$ 5.00 (at least 5 times more likely for hemorrhage patients)6.88 [6.04, 7.84]

    Note: The acceptance criteria were success criteria focusing on the device effectively and consistently differentiating between HRI Levels I, II, and III, and the ground truth for trauma patients tracking consistently with the algorithm results. The specific numerical targets for the Likelihood Ratios are derived from the interpretation in the document where "at least five times less likely," "almost as likely," and "nearly seven times more likely" were stated.

    Study Details

    FeatureDescription
    Test Set Sample Size5,895 patients (543 Hemorrhage Patients, 5,352 Control Patients)
    Test Set Data ProvenanceCountry of origin: Not explicitly stated, but collected from eight sites during patient transport and one hospital's Emergency Department within the context of a U.S. Army Medical Research and Development Command (USAMRDC) study. This implies a U.S. military-affiliated or broader U.S. patient population.
    Retrospective/Prospective: "prospectively, retrospectively" design, meaning it prospectively validated the device using retrospectively collected vital-sign data.
    Number of Experts for Ground TruthNot specified.
    Qualifications of ExpertsNot specified.
    Adjudication MethodNot specified.
    MRMC Comparative Effectiveness StudyNo. The study did not involve human readers comparing performance with and without AI assistance. Instead, it evaluated the standalone performance of the algorithm against established ground truth.
    Standalone PerformanceYes. The clinical utility study directly evaluated the performance of the APPRAISE-HRI algorithm (standalone) in stratifying hemorrhage risk.
    Type of Ground TruthClinical Trauma Registry Data: Information included blood transfusion details, documented hemorrhagic injuries, clinical notes, International Classification of Disease 10th Revision (ICD-10) codes, and Abbreviated Injury Scale (AIS) codes. Patients were labeled as "Hemorrhage" or "Control" based on these data.
    Training Set Sample SizeNot specified in the provided document.
    Training Set Ground Truth EstablishmentNot specified in the provided document.
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