(16 days)
The M2 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration of the blood in an extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarm levels.
The Spectrum M2 Monitor consists of a 10.4 inch high definition touch screen and three 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 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. Parameter values are displayed in both a digital and trended format. The M2 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 haemoglobin concentration. Session data can be stored to a memory card supplied with the system or via a RS232 link to a remote computer. 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.
The provided text from the 510(k) summary focuses on the intended use and technological characteristics of the M2 Monitor, particularly its substantial equivalence to predicate devices for monitoring oxygen saturation, hematocrit, and hemoglobin concentration.
However, it does not contain the detailed performance study results, acceptance criteria, sample sizes, ground truth establishment, or expert information typically required to fully answer your request regarding acceptance criteria and the study that proves the device meets them.
The document states:
"Performance data has been provided to show that the M2 Monitor can measure the oxygen saturation and hematocrit / haemoglobin concentration of blood and in extracorporeal circuit to an equivalent accuracy to its predicate device."
This indicates that such a study was performed and submitted to the FDA, but the results and methodology are not included in this summary.
Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.
Here's a breakdown of what CANNOT be extracted from the given text:
- A table of acceptance criteria and the reported device performance: This detailed data is not present. The document only states that performance data was provided for "equivalent accuracy."
- Sample sizes used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study is more common for diagnostic imaging AI, not typically for continuous physiological monitors like this.
- If a standalone study was done: While the performance data was likely for the device alone, the details of the study are not provided.
- The type of ground truth used: Not explicitly stated. For physiological monitors, ground truth often comes from a reference measurement method (e.g., laboratory blood gas analyzer for oxygen saturation, or a validated hematology analyzer for hematocrit/hemoglobin) rather than expert consensus.
- The sample size for the training set: Not mentioned (and likely not applicable in the same way as an AI model at this time, as this device uses a spectroscopic method compared to reference spectra).
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided text confirms a performance study was conducted to demonstrate equivalent accuracy to predicate devices, but it does not offer the granular details of that study or the specific acceptance criteria and results.
§ 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).