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510(k) Data Aggregation

    K Number
    K171901
    Device Name
    uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
    Manufacturer
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd
    Date Cleared
    2017-11-15

    (142 days)

    Product Code
    MHX,CCK,DQA,DRS,DRT,DSI,DSJ,DSK,DXG,DXN,FLL,MLD
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K152902
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The uMEC Series Patient Monitor family consists of the uMEC7, uMEC10, uMEC12, uMEC15 and uMEC15S patient monitors. All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, and transferring multiple physiological parameters. The specific indications for use are provided below.

    The uMEC series patient monitors are intended for monitoring, displaying, and transferring of multiple physiological parameters including ECG (3-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), cardiac output (C.O.), carbon dioxide (CO2).

    All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: The arrhythmia detection and SpO2 are intended for adult and pediatric patients only; ST Segment analysis is intended for adult patients only; and C.O. monitoring is restricted to adult patients only.

    The monitor is to be used in healthcare facilities by clinical professionals or under their guidance.

    Device Description

    The subject uMEC Series Patient Monitors include six monitors:

    • uMEC6 Patient Monitor
    • uMEC7 Patient Monitor
    • uMEC10 Patient Monitor
    • uMEC12 Patient Monitor
    • uMEC15 Patient Monitor
    • uMEC15S Patient Monitor

    The uMEC Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.

    AI/ML Overview

    The provided document is a 510(k) Summary for patient monitors, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating device performance against specific acceptance criteria for AI algorithms.

    Therefore, many of the requested elements for describing the acceptance criteria and the study proving the device meets them (especially those related to AI and human-in-the-loop performance) cannot be directly extracted from this document. The document outlines performance data related to the functional and system-level performance of the patient monitors (such as ECG accuracy, NIBP accuracy, etc.) by conforming to established consensus standards and conducting internal testing, but it does not describe a clinical study of an AI-based algorithm.

    However, I can extract information regarding the performance specifications for various physiological parameters as presented in the "Comparison of Technological Characteristics" section, which can be interpreted as the device's inherent acceptance criteria for these parameters.

    Let's break down what can be extracted and what cannot:

    Information that can be extracted or inferred:

    • Acceptance Criteria (as performance specifications): The comparison table details measurement ranges and accuracies for various physiological parameters (ECG, Respiration, Temp, SpO2, PR, NIBP, IBP, C.O., CO2). These are effectively the performance claims the device must meet.
    • Study Proving Acceptance Criteria: The document states that "Mindray conducted functional and system level testing on the subject device" and "Mindray has conducted testing to ensure the subject device meets relevant consensus standards." This indicates the type of study/testing performed, which is primarily non-clinical, bench testing, and verification against standards.

    Information that CANNOT be extracted from this document:

    • AI-specific Acceptance Criteria/Performance: The document does not describe AI components or their performance.
    • Sample size for test set (clinical): The document refers to "functional and system level testing" and conformity to standards, not a specific clinical test set with a patient sample size.
    • Data provenance for test set: Not available as it's not a clinical study on a data set.
    • Number/qualifications of experts for ground truth: Not applicable for non-clinical, functional testing.
    • Adjudication method for test set: Not applicable.
    • MRMC comparative effectiveness study: Not mentioned, as it's not an AI device.
    • Standalone (algorithm-only) performance: Not mentioned.
    • Type of ground truth used (clinical): Not specified beyond "relevant consensus standards" for verification.
    • Sample size for training set (AI): Not applicable.
    • How ground truth for training set was established (AI): Not applicable.

    Given these limitations, here is the information based on the provided document:

    1. A table of acceptance criteria and the reported device performance

    For a patient monitor, "acceptance criteria" are typically defined by the accuracy and measurement ranges across various physiological parameters. The document compares the subject device's performance claims against those of the predicate device.

    ParameterAcceptance Criteria (Predicate Device)Reported Device Performance (uMEC Series)
    ECG Heart Rate (HR)Measurement Range:Neonate: 15 to 350 bpm;Pediatric: 15 to 350 bpm;Adult: 15 to 300 bpm;Accuracy: ±1 bpm or ±1%, whichever is greater.Same as predicate device.
    ECG ST SegmentMeasurement Range: -2.0 to 2.0 mV RTI;Accuracy:-0.8 to 0.8 mV: ±0.02 mV or ±10%, whichever is greater.Beyond this range: Not specified.Same as predicate device.
    ECG QTMeasurement Range: [200, 800]ms;Accuracy: ±30msSame as predicate device.
    Arrhythmia AnalysisAsystole, VFib/VTac, Vtac, Vent. Brady, ExtremeTechy, Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R on T, RunPVCs,PVCs, Tachy, Brady, Missed Beats, Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac, Pause, Irr. Rhythm, Afib.Same as predicate device.
    Respiration Rate (Resp)Measurement Range:Adult: 0 to 120 rpm;Pediatric, neonate: 0 to 150 rpm.Accuracy: 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater;0 to 6 rpm: Not specified.Same as predicate device.
    Temperature (Temp)Measurement Range: 0 to 50 °C (32 to 122 F)Accuracy: ±0.1 °C or ±0.2 F (without probe)Same as predicate device.
    Pulse Oxygen Saturation (SpO2)MindraySpO2 Module:Measurement Range: 0 to 100%Accuracy: 70 to 100%: ±2% (adult/pediatric mode)70 to 100%: ±3% (neonate mode)0% to 69%: Not specified.(Note: Masimo & Nellcor SpO2 Modules also listed for predicate)MindraySpO2 Module:Measurement Range: 0 to 100%Accuracy: 70 to 100%: ±2% (adult/pediatric mode)0% to 69%: Not specified.MindraySpO2 Module do not support neonate mode and the specifications for Adult/pediatric are same.Not Support Masimo and NellcorSpO2 Module. (This is a difference, not an identical acceptance criterion, and indicates a narrower scope for the uMEC).
    Pulse Rate (PR)From MindraySpO2 Module:Measurement Range: 20 to 254 bpmAccuracy: ±3 bpm(Other module PR also listed)From MindraySpO2 Module:Measurement Range: 20 to 254 bpmAccuracy: ±3 bpmNot Support Masimo and NellcorSpO2 Module.From IBP Module:Measurement Range: 25 to 350 bpmAccuracy: ±1 bpm or ±1%, whichever is greater.
    Non-Invasive Blood Pressure (NIBP)Measurement Ranges (Systolic/Diastolic/Mean):Adult: 40-270 / 10-210 / 20-230 mmHgPediatric: 40-200 / 10-150 / 20-165 mmHgNeonate: 40-135 / 10-100 / 20-110 mmHgAccuracy: Max mean error: ±5 mmHg, Max standard deviation: 8 mmHgMeasurement Ranges (Systolic/Diastolic/Mean):Adult: 25-290 / 10-250 / 15-260 mmHgPediatric: 25-240 / 10-200 / 15-215 mmHgNeonate: 25-140 / 10-115 / 15-125 mmHgAccuracy: Max mean error: ±5 mmHg, Max standard deviation: 8 mmHgThe measurement range of subject devices is wider than the predicate device.
    Invasive Blood Pressure (IBP)Measurement Range: -50 to 300 mmHgAccuracy: ±2% or ±1 mmHg, whichever is greater (without sensor)Same as predicate device (where supported). uMEC6 does not support IBP.
    Cardiac Output (C.O.)Measurement Range: C.O: 0.1 to 20 L/min; TB: 23 to 43 °C; TI: 0 to 27 °CAccuracy: C.O: ±5% or ±0.1 L /min, whichever is greater; TB, TI: ±0.1 °C (without sensor)Same as predicate device (where supported). Not supported by uMEC6, uMEC10, uMEC7.
    Carbon Dioxide (CO2)Sidestream CO2 Module:Measurement Range: 0 - 13%Accuracy: 0-5%: ±0.26% abs; 5-10%: ±5% of the reading; 10-13%: ±10% of the reading; ±0.3% ABS increase in error for ISO accuracy mode.awRR Range: 0 to 120rpmawRR Accuracy: ±2rpmSidestream CO2 Module:Measurement Range: 0 to 20%Accuracy: CO2 concentration<1%: ±0.1%; 1%≤CO2<5%: ±0.2%; 5%≤CO2<7%: ±0.3%; 7%≤CO2<12%: ±0.4%; 12%≤CO2≤13%: ±0.5%; 13%<CO2≤20%: ±(0.43%+8%rel); ±0.3% ABS increase in error for ISO accuracy mode.awRR Range: 0 to 150rpmawRR Accuracy: <60rpm: ±1rpm; 60 to 150 rpm: ±2rpm.The CO2 measurement range of subject devices is wider than the predicate device. The awRR measurement range of subject devices is wider than the predicate device. The Accuracy of awRR is also improved. Not supported by uMEC6, uMEC10, uMEC7.

    Study that proves the device meets the acceptance criteria:

    The document describes the following types of testing:

    • "Functional and system level testing": Mindray conducted this testing on the subject device to evaluate its performance relevant to differences between the subject and predicate devices. This testing "showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate."
    • Conformity to Consensus Standards: Mindray asserts that they "has conducted testing to ensure the subject device meets relevant consensus standards" including:
      • AAMI / ANSI EC57:2012 (Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms)
      • IEC 60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 (General requirements for basic safety and essential performance)
      • IEC 60601-1-2:2007 (Electromagnetic compatibility)
      • IEC 60601-1-8:2012 (Alarm systems)
      • IEC 60601-1-6: 2013 (Usability)
      • IEC 60601-2-49:2011 (Multifunction patient monitoring equipment)
      • IEC 60601-2-27:2011 (Electrocardiographic monitoring equipment)
      • IEC 60601-2-34:2011 (Invasive blood pressure monitoring equipment)
      • IEC 80601-2-30:2013 (Automated non-invasive sphygmomanometers)
      • ISO 80601-2-56: 2009 (Clinical thermometers for body temperature measurement)
      • ISO 80601-2-61: 2011 (Pulse oximeter equipment)
      • ISO 80601-2-55: 2011 (Respiratory gas monitors)
      • IEC 62133: 2012 (Secondary cells and batteries safety requirements)

    2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    This information is not provided in the document as the testing described is primarily functional/system-level verification against standards, not a clinical study on a patient test set.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    This information is not provided as the ground truth refers to the performance specifications against which the device was tested, validated by adherence to consensus standards, rather than expert annotation of clinical data.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    This information is not provided as it relates to clinical data adjudication, which is not described.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    No such study was mentioned. The device is a patient monitor, not an AI-assisted diagnostic tool.

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

    This concept is not relevant to the described functional testing of a patient monitor.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    The "ground truth" for the device's performance is established by the international consensus standards listed in the "Performance Data" section (e.g., AAMI / ANSI EC57 for cardiac rhythm and ST-segment algorithms, various IEC and ISO standards for different parameters). The device's performance is validated by meeting the specifications and requirements set forth in these standards.

    8. The sample size for the training set

    This information is not applicable as the document describes a patient monitor that is not indicated for using AI/machine learning with a "training set" in the context of diagnostic algorithms.

    9. How the ground truth for the training set was established

    This information is not applicable as there is no mention of a training set for an AI algorithm.

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