(27 days)
Patient Monitors, M8500, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. They are not intended for helicopter transport or hospital ambulance.
The proposed devices are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. They have the alarming function with audio and visual alarming which may raise the user attention of system error and exceeding the pre-set limit of physiological parameter, and data storage function, which can replay the data and alarming event. The device is driven by AC or DC power supply.
The provided text is a 510(k) summary for a Patient Monitor (Model M8500) and it does not contain the detailed study information typically requested for devices that employ AI/ML algorithms, especially regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, or MRMC studies.
The document states: "Per the risk management during the design change control, the verification tests performed demonstrated that risks of each hazard are reduced to acceptable region." This is a very general statement and does not provide specific acceptance criteria or study details for performance.
The device described is a multi-parameter patient monitor (ECG, HR, RESP, SpO2, PR, NIBP, CO2, TEMP), which are traditional physiological monitoring measurements. These types of devices are typically cleared based on meeting established performance standards for each physiological parameter (e.g., accuracy, precision) rather than AI/ML performance metrics.
Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication, or MRMC studies from the provided text, as it describes a conventional medical device and not one heavily reliant on AI/ML algorithms or image interpretation that would require such extensive validation details in a 510(k) summary.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.