(15 days)
The M3 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation, hematocrit / haemoglobin concentration and the flow of the blood in an extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to alarm to set parameter specific alarms.
The Spectrum M3 Monitor consists of a 10.4 inch high definition touch screen and four active measuring channels mounted into a flat panel unit. Sensor cables are used to connect the active measuring channels to the external surface of extracorporeal blood line tubing. Two active measuring channels are used to measure venous and arterial oxygen saturation. The sensor cable head contains a light emitting diode that sends light through the extracorporeal tube, which illuminates the 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. The third active measuring channel is used to measure hematocrit or haemoglobin concentration. The sensor cable head contains a light emitting diode that transmits near-infra-red light through the extracorporeal tube. A photo diode measures a received light level. The level of signal attenuation is used to calculate hematocrit or haemoglobin concentration. The fourth active measuring channel is used to measure blood flow using Transonic proprietary technology. Flow measurement is accomplished by measuring the difference in transit time between a pair of upstream and down stream ultrasonic transducers. Parameter values are displayed in both a digital and trended format. The M3 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 or via a RS232 link to a remote computer. The M3 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 an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lacks a specific, quantitative "acceptance criteria" table with corresponding numerical performance targets. Instead, the justification for substantial equivalence relies on the device having "equivalent accuracy" to predicate devices.
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Oxygen Saturation | Equivalent accuracy to predicate M2 monitor | "can measure... to an equivalent accuracy of the predicate devices." (No specific numerical accuracy provided) |
| Hematocrit / Hemoglobin Concentration | Equivalent accuracy to predicate M2 monitor | "can measure... to an equivalent accuracy of the predicate devices." (No specific numerical accuracy provided) |
| Flow Measurement | Equivalent accuracy to predicate Transonic Flowmeter | "can measure... to an an equivalent accuracy of the predicate devices." (No specific numerical accuracy provided) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide any specific information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). The statement "Performance data has been provided to show that the M3 Monitor can measure the oxygen saturation, hematocrit / haemoglobin concentration and flow of blood in extracorporeal blood tubing to an equivalent accuracy of the predicate devices" is the extent of the information.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of human experts to establish ground truth for a test set. The focus is on technical equivalence to existing devices and "gold-standard" flow sensors.
4. Adjudication Method:
Given that there's no mention of human experts or a test set requiring adjudication, there is no information about an adjudication method (e.g., 2+1, 3+1, none) in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a "Blood Gas Monitor" and not an imaging or diagnostic device that would typically involve human readers for interpretation. The evaluation focuses on the device's measurement accuracy compared to predicate devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The provided text implicitly describes a "standalone" evaluation of the device's technical performance. The "performance data" mentioned is focused on the device's ability to measure parameters accurately, independent of human interaction beyond initial setup and configuration. This is not explicitly called a "standalone study" in the modern sense of AI algorithms, but the nature of the device's function implies its core measurement capabilities were assessed independently.
7. Type of Ground Truth Used:
- Oxygen Saturation and Hematocrit/Hemoglobin Concentration: The document does not explicitly state how "ground truth" was established for these parameters during the "performance data" collection. It only states that the proposed device has the "same technological characteristics" as its predicate and aims for "equivalent accuracy." This often implies comparison against more established laboratory methods or reference instruments, but this is not detailed.
- Flow Measurement: For flow, the ground truth is established using a "gold-standard" flow sensors, which are tested by timed fluid collection using NIST traceable stopwatch and volume standards.
8. Sample Size for the Training Set:
The provided text does not mention a "training set" or "sample size for the training set." This device, a Blood Gas Monitor, operates on established biophysical principles and algorithms, likely calibrated during its manufacturing process. It does not appear to employ machine learning that would necessitate a distinct "training set" in the context of typical AI/ML medical devices.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" (see point 8), there is no information on how its ground truth would have been established. The device relies on physical principles and calibration, not a machine learning model trained on a dataset with established ground truth.
§ 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).