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510(k) Data Aggregation

    K Number
    K171942
    Date Cleared
    2018-01-24

    (210 days)

    Product Code
    Regulation Number
    870.2340
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K152427

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

    The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and disease. However, the interreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

    Device Description

    The SE-12/12 Express/1200/1200 Express Electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms, and be powered by the mains supply or battery. And the system has advanced performance and high reliability due to high resolution thermal recorder, 32-bit processor and a large-capacity memorizer. Design of the system took much consideration on ergonomics so the size is suitable for clinic and hospital uses.

    There are four selectable modes in the system, including manual, auto, rhythm, R-R analysis or VCG, and VCG is configured with SE-12 Express & SE-1200 Express.

    SE-12 and SE-1200 share the same single-color LCD screen of which the resolution is 320×240 dot; and LCD screen of SE-12 Express and SE-1200 Express is 800×600 multicolor LCD screen.

    Moreover, SE-12 Express is configured with stress ECG function, which will allow to diagnose concealed coronary heart disease and atypical angina pectoris, prescribe the workload for patients with myocardial infarction before leaving hospital, and assess the effect of the treatment.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for an Electrocardiograph device (models SE-12, SE-12 Express, SE-1200, and SE-1200 Express). It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/algorithm's performance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical data and comparisons of technical specifications.

    Therefore, many of the requested items related to an AI study, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not available in the provided text.

    However, I can extract the acceptance criteria and performance information that is available, which pertains to the device's general technical specifications and safety/EMC standards.


    Acceptance Criteria and Reported Device Performance

    The acceptance criteria are generally implied by the "Same" or "Different" comparison to the predicate device for various specifications, as well as compliance with relevant standards. The reported device performance is either identical to the predicate (marked as "Same") or an improved/different specification (marked as "Different").

    Note: The "Comparison Result" column indicates if the proposed device's specification is "Same" or "Different" from the predicate. When "Different," the proposed device's performance is listed.

    Acceptance Criteria CategorySpecific MetricDevice Performance (Proposed Device)Comparison Result (vs Predicate)
    Intended UsePatient Age RangeAdult and pediatric patient (beginning at birth through 21 years of age)Different
    Safety SpecificationsSafety Standards ComplianceIEC 60601-1:2005/A1:2012, EN 60601-1:2006/A1:2013, IEC 60601-1-2:2007, EN 60601-1-2:2007/AC:2010, IEC/EN 60601-2-25Same
    Anti-electric-shock typeClass I with internal power supplySame
    Anti-electric-shock degreeType CFSame
    Degree of protection against harmful ingress of waterOrdinary equipment (Sealed equipment without liquid proof)Same
    Disinfection/sterilization methodRefer to the user manual for detailsSame
    Degree of safety in flammable gas presenceEquipment not suitable for use in the presence of flammable gasSame
    Working modeContinuous operationSame
    EMCCISPR 11 Group 1, Class ASame
    Ingress ratingIPX0Same
    Environmental SpecsTransport & Storage Temperature-20°C (-4°F) ~ +55°C (+131°F)Same
    Working Temperature+5°C (+41°F) ~ +40°C (+104°F)Same
    Transport & Storage Relative Humidity25%~93% Non-CondensingSame
    Working Relative Humidity25% RH ~ 80% RH Non-CondensingSame
    Transport & Storage Atmospheric Pressure700 hPa ~1060 hPaSame
    Working Atmospheric Pressure860 hPa ~1060 hPaSame
    Power Supply SpecsMains Supply Operating Voltage100V-240V~Same
    Mains Supply Operating Frequency50 Hz / 60 HzSame
    Mains Supply Input Current0.9-0.4ASame
    Mains Supply Input Power96VASame
    Battery Pack Rated Voltage14.8 VSame
    SE-12 Express & SE-1200 Express Battery Capacity5000mAhSame
    SE-12 & SE-1200 Battery Capacity2500mAhSame
    Battery Work Time (Full Charge, SE-12 & SE-1200)Approx. 4 hours normally; approx. 1.5 hours continual print (manual); approx. 300 ECG reports (auto, 3x4+1R)Same
    Battery Work Time (Full Charge, SE-12 Express & SE-1200 Express)Approx. 5 hours normally; approx. 2.5 hours continual print (manual); approx. 350 ECG reports (auto, 3x4+1R)Same
    Performance SpecsRecorder TypeThermal dot-matrix recorderSame
    Printing Density (amplitude axes)8 dots per mm / 200 dots per inchSame
    Printing Density (time axes, @ 25mm/s)40 dots per mm / 1000 dots per inchSame
    Recorder Paper (Folded Thermal)210mm×295mm×100pages OR 215mm×280mm×100pages (Optional)Same
    Recorder Paper (Rolled Thermal)210mm×30m (Optional)Same
    Effective Width210mmSame
    Paper Speed5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s (±3%)Same
    Accuracy of data±5% (x-axis), ±5% (y-axis)Same
    HR Recognition TechniquePeak-Peak DetectionSame
    HR Range30 BPM ~ 300 BPMSame
    HR Accuracy±1 BPMSame
    ECG Unit LeadsStandard 12 leadsSame
    Acquisition ModeSimultaneously 12 leadsSame
    A/D Resolution24 bitsSame
    Resolution2.52uV/LSBSame
    Time Constant≥ 3.2 sSame
    Frequency Response0.01Hz ~ 300 Hz (-3 dB)Different
    Gain1.25, 2.5, 5, 10, 20, 10/5, AGC (mm/mV)Same
    Input Impedance≥100MΩ (10Hz)Different
    Input Circuit Current≤0.01μASame
    Input Voltage Range≤±5 mVppSame
    Calibration Voltage1mV±2%Same
    DC Offset Voltage±600 mVSame
    Noise≤12.5 µVp-pSame
    Multi-channel Crosstalk≤0.5 mmSame
    Filter (AC Filter)On / OffSame
    Filter (DFT Filter)0.01Hz/0.05Hz / 0.15Hz / 0.25Hz / 0.32Hz / 0.5Hz / 0.67HzDifferent
    Filter (EMG Filter)25Hz / 35Hz / 45Hz / OFFSame
    Filter (LOWPASS Filter)300Hz/270Hz/150Hz / 100Hz / 75HzDifferent
    CMRR≥140dB (AC ON), ≥123dB (AC OFF)Different
    Sampling Frequency16000HzDifferent
    Pacemaker DetectionAmplitude±750uV to ±700 mVDifferent
    Width50µs to 2.0 msDifferent
    Sampling Frequency16,000/sec/channelDifferent
    External Input/outputInput≥100 kΩ; Sensitivity 10 mm/V±5%; Single endedSame

    Study Details (Information Not Available in the Provided Text)

    The document is a 510(k) summary for a medical device (Electrocardiograph) seeking substantial equivalence to a previously cleared predicate device. It primarily focuses on hardware specifications, safety, EMC, and software verification/validation. It does not describe a study involving an AI or algorithm's diagnostic performance beyond stating that "ECG interpretation features were also validated by database testing." As such, the following requested information is not explicitly detailed in the provided text:

    1. Sample size used for the test set and the data provenance: Not explicitly stated for specific diagnostic performance of the interpretation features, beyond "database testing."
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not stated.
    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not stated.
    4. 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 MRMC study is mentioned. The device's interpreted ECG with statements is "offered to clinicians on an advisory basis only," indicating it's an assistive tool, but no comparative effectiveness study with human readers is described.
    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document mentions "ECG interpretation features were also validated by database testing," which suggests standalone algorithm testing, but details on its specific performance metrics (e.g., sensitivity, specificity, accuracy) are not provided.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not stated for the "database testing" of interpretation features.
    7. The sample size for the training set: Not stated.
    8. How the ground truth for the training set was established: Not stated.

    The document primarily demonstrates that the updated hardware and software of the Electrocardiograph maintain the safety and effectiveness profile of its predicate device, rather than providing a detailed study of an AI's diagnostic performance against specific acceptance criteria.

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