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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.

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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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