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    K Number
    K221267
    Device Name
    VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
    Manufacturer
    Shenzhen Mindray Bio-Meidcal Electronics Co., LTD
    Date Cleared
    2022-12-15

    (227 days)

    Product Code
    MWI,CCK,DQA,DXN,FLL
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K011291,K211475
    Why did this record match?
    Device Name :

    VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor

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

    The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, storing, alarming, and transfering of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.

    The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The VS 9/VS 8/VS 8A Vital Signs Monitor are not intended for helicopter transport, hospital ambulance, or home use.

    Device Description

    The subject VS series Vital Signs Monitors includes three monitors:

    • VS 9 Vital Signs Monitor
    • VS 8 Vital Signs Monitor
    • VS 8A Vital Signs Monitor .

    The VS series Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. The monitors should only be used by persons who have received adequate training in their use.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

    Device: Mindray VS Series Vital Signs Monitors (VS 9/VS 8/VS 8A)
    Parameter for Analysis: Temperature (Temp) measurement using the new Mindray Temp Module (TrueTemp) in Predictive mode.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for temperature measurement are based on the requirements of ISO 80601-2-56:2017/Amd.1:2018(E). The summary provides statistical results from a clinical investigation.

    Acceptance Criteria (from ISO 80601-2-56:2017/Amd.1:2018(E))Reported Device Performance (Mindray TrueTemp Module - Predictive Mode)Body Site
    Not explicitly stated in the document, but assessed against ISO standard for clinical accuracy. The "Similar" predicate performance (SmarTemp) provides a point of comparison.Clinical BIAS (Δcb): 0.03°COral
    Limits of Agreement (LA): 0.37°COral
    Clinical Repeatability (στ): 0.14°COral
    Clinical BIAS (Δcb): 0.03°CAxilla
    Limits of Agreement (LA): 0.32°CAxilla
    Clinical Repeatability (στ): 0.12°CAxilla
    Clinical BIAS (Δcb): -0.06°CRectum
    Limits of Agreement (LA): 0.38°CRectum
    Clinical Repeatability (στ): 0.14°CRectum

    Note: The document states that the performance of the TrueTemp module "meets the requirements of ISO 80601-2-56:2017/ Amd.1:2018(E) for temperature measurement and meets the acceptance criteria in clinical protocol." While the specific numerical acceptance criteria from the ISO standard are not explicitly listed in the table, the reported performance metrics are the results of testing against those criteria. The predicate device's performance is also included in the table in the full submission, showing similar statistical results.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set:
      • 106 valid cases for oral temperature.
      • 110 valid cases for axillary temperature.
      • 109 valid cases for rectal temperature.
    • Data Provenance: The study was a clinical investigation conducted by Mindray. The country of origin is not explicitly stated in the provided abstract, but Mindray is a Chinese company (Shenzhen, Guangdong, P.R. China), suggesting the study likely took place in China. It was a prospective clinical investigation as it aimed to meet specific requirements for validity and accuracy of the new module.
    • Subject Demographics: The study included subjects in three age groups: infants (newborn to one year), children (greater than one to five years), and adults (greater than five years old). The age of subjects ranged from 4 days to 67 years old. The total number of febrile subjects constituted not less than 30% and not greater than 50% of all subjects in each selected age group and body site.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

    This information is not explicitly provided in the summary. The ground truth (reference temperature) was established by comparing the TrueTemp module's measurements to the "direct mode of WelchAllyn SureTemp PLUS 690." It's likely that a trained clinical professional operated the reference thermometer, but the specific number and qualifications of experts involved in establishing the "ground truth" are not detailed.

    4. Adjudication Method for the Test Set

    The adjudication method is not explicitly stated. Given that the ground truth was established by a comparative measurement against a reference device (WelchAllyn SureTemp PLUS 690), it implies a direct comparison rather than an expert consensus requiring an adjudication process.

    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

    This is not applicable. The device is a vital signs monitor that directly measures physiological parameters like temperature. It is not an AI-assisted diagnostic tool that involves human readers or interpretation of medical images/data in a way that would necessitate an MRMC comparative effectiveness study to assess human improvement with AI assistance.

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

    Yes, a standalone performance evaluation was done for the temperature measurement function. The clinical investigation directly assessed the accuracy and validity of the "new Mindray Temp Module (TrueTemp)" in its predictive mode compared to a reference standard (WelchAllyn SureTemp PLUS 690). This evaluation focused on the device's intrinsic measurement capabilities without assessing human interaction or interpretation as part of the core performance metrics discussed here.

    7. The Type of Ground Truth Used

    The ground truth used was comparison to a legally marketed reference device: the "direct mode of WelchAllyn SureTemp PLUS 690," which is itself a clinical thermometer. This is a form of comparative measurement against a recognized standard in the field.

    8. The Sample Size for the Training Set

    The document does not provide information regarding a separate training set for the Mindray TrueTemp module's temperature measurement function. Given that this is a hardware module (thermal resistance technique) with associated algorithms for predictive mode, its development and calibration would typically involve internal technical specifications and potentially laboratory testing, but "training set" in the context of machine learning is not directly applicable or reported for this type of device in the provided summary.

    9. How the Ground Truth for the Training Set Was Established

    As no training set information is provided, how its ground truth was established is not discussed in this document.

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