(56 days)
The intended use of the M4 Monitor is for the non-invasive continuous monitoring of O2 saturation, hematocrit and haemoglobin concentration, blood flow, gaseous emboli, Temperature, PO2, and PCO2, in an extracorporeal circuit.
The device provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
The Spectrum M4 Monitor consists of a 10.4 inch high definition touch screen and sensor assemblies connected to a flat panel display unit. Optical sensor assemblies are used to collect data for the measurement of Arterial and Venous Saturation and Hot / Hb. Ultrasonic sensors are used to collect data for the measurement of flow and gaseous emboli. A thermistor is used for the collection of temperature data. Inlet and outlet gas measurements sensors are used to collect data for the measurement of PO2, and PCO2.
Parameter values are displayed in both a digital and trended format. The M4 Monitor has been designed to self-detect the selected sensor and to automatically configure the required parameter display screens. The device can be configured by the trained clinician to set parameter specific alarms and to select either the display of hematocrit or haemoqlobin concentration. Session data can be stored to a memory card supplied with the system, via a RS232 link or wirelessly to a remote computer.
The M4 Monitor is powered from the AC Mains supply and also incorporates a battery back-up that automatically switches on in the event of an interruption to the mains power supply. The system weighs 4.5 kg and is supplied with a pole mount clamp.
The provided text K110957 describes a medical device called the "M4 Monitor" and its substantial equivalence to predicate devices, but it does not contain any information about specific acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results with acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions regarding sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for the M4 Monitor based on the provided text.
The closest information available is a general statement about performance:
"Performance data has been provided to show that the revised M4 Monitor can measure the oxygen saturation, hematocrit / haemoglobin concentration, blood flow, gaseous emboli, Temperature, PO2, and PCO2."
This statement confirms that performance data was provided to the FDA, but the content of that data, including specific acceptance criteria or study methodologies, is not detailed in this 510(k) summary.
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).