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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.

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The M2 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation of the blood in an extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to alarn for set saturation levels.

The Spectrum M2 Monitor consists of a 10.4 inch high definition touch screen and two active measuring channels mounted into a flat panel unit. Sensor cables are used to connect one or both measuring channels to the external surface of extracorporeal blood line tubing. The sensor cable head contains a light emitting diode that sends light through the extracorporeal tube, which illuminates the flowing blood. The reflected spectra is collected by a fibre optic cable and quantified by a photo-detector contained within a spectrometer. These spectra are compared to reference spectra by the monitor's software to determine the oxygen saturation of the blood in the extracorporeal line. The oxygen saturation levels for venous blood flow alone or both venous and arterial can be displayed by using one or both sensor channels. A trace of these oxygen levels are also displayed on the monitor. The M2 Monitor has been designed to selfdetect the selected sensor and to automatically configure the required parameter display screens. The device can be configured by the trained clinician to alarm for set saturation levels on either channel and to record session data onto a memory card supplied with the system. The M2 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.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that "Performance data has been provided that shows that the proposed device achieves equivalent accuracy for the measurement of oxygen saturation of the blood to the predicate device." While no specific numerical acceptance range is provided, the criterion is to match the predecessor's accuracy.

2. Sample Size and Data Provenance

The provided 510(k) summary does not contain details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only generally states "Performance data has been provided."

3. Number of Experts and Qualifications for Ground Truth

The provided 510(k) summary does not contain details regarding the number of experts used to establish ground truth or their specific qualifications.

4. Adjudication Method for the Test Set

The provided 510(k) summary does not contain details regarding the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided document. The focus is on the device's standalone performance compared to a predicate device.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The document explicitly states: "Performance data has been provided that shows that the proposed device achieves equivalent accuracy for the measurement of oxygen saturation of the blood to the predicate device." This refers to the M2 Monitor's performance itself.

7. Type of Ground Truth Used

The type of ground truth used is implicitly the measurement provided by the predicate device (K931968 3M Health Care, Ltd CDI 100 Extracorporeal Hematocrit / Oxygen Monitoring Device). The M2 Monitor's performance is compared for "equivalent accuracy" to this predicate. The predicate device, being an "Extracorporeal Hematocrit / Oxygen Monitoring Device," would have its own established method of determining oxygen saturation, which serves as the reference for the M2.

8. Sample Size for the Training Set

The provided 510(k) summary does not contain details regarding the sample size used for any training set.

9. How Ground Truth for the Training Set Was Established

The provided 510(k) summary does not contain details regarding how ground truth was established for any training set, as a training set is not explicitly mentioned. Given the nature of a 510(k) summary primarily focusing on substantial equivalence, detailed algorithm training specifics are often omitted unless directly relevant to a novel aspect of the device.

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