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The 3M CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 ° C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.

The 3M CDI Blood Parameter Monitoring System 500 is an AC-powered (battery backup), microprocessor-based device used with disposable sensor elements for the purpose of monitoring arterial and/or venous pH, pCO2, pO2, potassium, saturation, hematocrit, and hemoglobin in the extracorporeal tubing circuit during partial or complete cardiopulmonary bypass.

The sensing element is introduced into the extracorporeal circuit by means of a heparin-coated sterile flow-through sensor for gas, potassium ion, and hydrogen ion measurement, and by means of a heparin-coated cuvette which allows measurement while maintaining a sterile path.

For pH, pCO2, pO2, and potassium measurement, a light is emitted from light emitting diodes (LED's) in the cable head to the sensors. Each sensor contains individual microsensors for the pH, pCO2, pO2, and potassium parameters. The microsensors contain fluorescent dyes which emit light in response to the stimulating light from the LED's. The intensity of the emitted light is dependent upon the concentration of O2 CO2 potassium ions or hydrogen ions coming in contact with the microsensors. The intensity of the emitted light is then converted to a numerical value in mmHg, kilopascals, mEq/l, or pH units and displayed on the face of the monitor. For saturation, hematocrit and hemoglobin measurement, a light is emitted from LEDs in the probe to the cuvette and reflected back into the probe depending on the saturation of the blood and the hemoglobin present. The reflected light is then converted to a numerical value in saturation percentage, hematocrit percentage, or g/dl.

Here's a breakdown of the acceptance criteria and study information for the 3M CDI Blood Parameter Monitoring System 500, based on the provided text:

Acceptance Criteria and Device Performance:

The document explicitly states: "The performance characteristics of the 3M CDI Blood Parameter Monitoring System 500 were exhaustively tested and compared with the performance characteristics of the currently marketed 3M CDI System 400 Blood Gas Monitoring System, the 3M CDI System 100 Hematocrit/Oxygen Saturation Monitoring System, and Mallinckrodt Gem 6 Blood Gas/Electrolyte Monitor. All new and existing performance characteristics of the 3M CDI Blood Parameter Monitoring System 500 have been validated."

However, specific numerical acceptance criteria (e.g., accuracy ranges, precision limits) and corresponding reported device performance values (e.g., actual measured accuracy, precision) are not provided in the submitted text. The submission focuses on substantial equivalence to predicate devices and asserts that the new device "performs as intended according to its performance specifications." Without the specifications themselves, a table of acceptance criteria and reported performance cannot be generated.

Therefore, the table below reflects the stated intent of the testing and the lack of specific numerical data in this excerpt.

Study Information:

1. Sample size used for the test set and the data provenance:
   The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "exhaustive testing" and "validation" but provides no details on the number of samples or their source.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. The study described is a non-clinical performance test, likely involving comparison to laboratory reference methods or predicate devices, rather than expert interpretation of medical images or data.

3. Adjudication method for the test set:
   This information is not provided because the nature of the "testing" described is non-clinical performance comparison, not a reader study requiring adjudication.

4. 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:
   No, an MRMC comparative effectiveness study was not done. The device is a blood parameter monitoring system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting data.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Yes, the description of "Nonclinical Performance" suggests that the device's performance was evaluated in a standalone manner, comparing its measurements to established methods or predicate devices. The phrase "exhaustively tested and compared with the performance characteristics of the currently marketed 3M CDI System 400... and Mallinckrodt Gem 6 Blood Gas/Electrolyte Monitor" implies a direct, objective measurement and comparison of the device's output.

6. The type of ground truth used:
   The ground truth would implicitly be the validated measurements from the predicate devices (3M CDI System 400, 3M CDI System 100) and the Mallinckrodt Gem 6 Blood Gas/Electrolyte Monitor, or possibly laboratory reference standards against which these predicate devices themselves were validated. The document focuses on substantial equivalence to these existing devices.

7. The sample size for the training set:
   The document does not mention a "training set" as this device predates the common application of machine learning that requires such a set. The testing described is classic device validation against established performance.

8. How the ground truth for the training set was established:
   Not applicable, as no training set is mentioned or implied for this type of medical device's non-clinical validation.

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