(90 days)
M Series Patient Monitor is 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), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.
The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.
The proposed device, M Series Patient Monitor (M66, M69, M8000 and M9000) is 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), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.
It has 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 describes a 510(k) submission for the M Series Patient Monitor. It focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or an AI/algorithm component.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI component, as this information is not present in the given document.
The document only states that:
- "Laboratory testing was conducted to validate and verify that M Series Patient Monitor met all design specifications, including electrical safety, EMC, biocompatibility, specification."
- "Results of these tests demonstrate compliance to the requirements of all consensus standards."
Without further details on these "design specifications" or "consensus standards" and the specific results of "laboratory testing," I cannot create the table or answer the other detailed questions you've posed. The document is a regulatory submission for a patient monitor and not a clinical study report for an AI device.
§ 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.