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The intended use of the M3 Monitor is for the non- invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration, blood flow and gaseous emboli 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 M3 Monitor consists of a 10.4 inch high definition touch screen and five 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 bematocrit 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.

Three further active and optional measuring channels (i.e. the fourth, fifth and sixth channels) are used to measure simultaneously blood flow and the presence of emboli. Flow measurement is accomplished by measuring the difference in transit time between a pair of upstream and down stream ultrasonic transducers. Emboli is measured by detecting reductions in the amplitude of the ultrasonic signal.

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 haemoglobin 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 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.

The provided text describes a 510(k) submission for the Spectrum Medical M3 Monitor, but it does not contain specific acceptance criteria or a study detailed enough to directly create the requested table and answer all questions.

The document states that "Performance data has been provided to show that the revised M3 Monitor can measure the oxygen saturation, hematocrit / haemoglobin concentration, the flow of blood and gaseous emboli in an extracorporeal circuit to an equivalent or improved accuracy when compared to the predicate devices." However, it does not provide the actual performance data, acceptance criteria values, or details of the study methodology.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or answer specific questions about sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

Based on the information available, here's what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be generated. The document states that performance data "has been provided" to the FDA, but the data itself and the specific acceptance criteria (e.g., accuracy +/- X%) are not included in this summary.

2. Sample size used for the test set and the data provenance:

• Cannot be determined. This information is not provided in the text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Cannot be determined. This information is not provided in the text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be determined. This information is not provided in the text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Cannot be determined. The device is a "Blood Gas Monitor" for objective physiological measurements (oxygen saturation, hematocrit, hemoglobin, blood flow, emboli). The concept of "human readers improving with AI assistance" is typically relevant for interpretative tasks (e.g., radiology image interpretation), not for direct physiological monitoring. This type of study would likely not be applicable to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, implicitly. The device is a monitor that provides continuous measurements. The performance comparison mentioned ("can measure...to an equivalent or improved accuracy when compared to the predicate devices") refers to the device's inherent measurement capabilities, which would be a standalone assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Implied, but not explicitly stated. For physiological monitors, ground truth is typically established by:
  • Comparison to a gold standard laboratory instrument (e.g., a co-oximeter for oxygen saturation, a hematology analyzer for hematocrit/hemoglobin).
  • Highly accurate flow measurement systems for blood flow.
  • Controlled experimental setups for emboli detection.
    The document does not specify which gold standards were used.

8. The sample size for the training set:

• Cannot be determined. The document does not mention details about training data for the device's software.

9. How the ground truth for the training set was established:

• Cannot be determined. The document does not mention details about training data or its ground truth establishment.

Summary based on available information:

The document is a 510(k) summary for the M3 Monitor. It focuses on establishing substantial equivalence to predicate devices (K072131 Spectrum Medical - M3 Monitor and K940651 Sarns - Ultrasonic Air Sensor). The "study" mentioned is a general statement that "Performance data has been provided to show that the revised M3 Monitor can measure...to an equivalent or improved accuracy when compared to the predicate devices." This implies a standalone performance study was conducted, comparing the device's measurements to a reference, but the specifics of that study (e.g., acceptance criteria, test set size, ground truth details) are not included in this public summary.

Without the actual performance data and detailed study report, a comprehensive answer to your questions cannot be provided.

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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.

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.

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