(20 days)
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
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy of Oxygen Saturation Measurement | Equivalent to predicate device | Achieves equivalent accuracy to the predicate device K931968 (3M CDI 100 Extracorporeal Hematocrit / Oxygen Monitoring Device) |
| Non-invasiveness | Non-invasive | Completely non-invasive measurement |
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.
§ 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).