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The 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 CDI™ System 500 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:

• CDI™ 500 Monitor .
• Arterial and/or Venous Blood Parameter Modules (BPM) .
• CDI™ H/S Probe .
• CDI™ 540 Gas Calibrator and Calibration Gases (A and B) .
• CDI™ 510H Shunt Sensor .
• Shunt Bypass Line .
• CDI™ H/S Cuvette with or without extension tubing .
• Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket) .
• . Printer Paper
  The CDI™ System 500 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electrooptics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI™ 500 Monitor in real time, and displayed to the user via a graphical LCD display.

The provided text describes a 510(k) summary for the CDI™ Blood Parameter Monitoring System 500, a device for continuous, on-line monitoring of various blood parameters during cardiopulmonary bypass. The submission is for "Modifications to previously cleared system" and aims to demonstrate substantial equivalence to predicate devices K123039 and K972962.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document states that the performance testing was conducted to "verify/validate the changes to the CDI™ System 500". The conclusion section further states that the modified device has "substantially equivalent performance specifications as compared to the predicate device." However, no specific quantitative acceptance criteria or detailed results of device performance metrics (e.g., accuracy, precision for each parameter like pH, pO2, pCO2, etc.) are provided in this summary. The document only broadly mentions "System verification testing in a blood loop to simulate clinical use."

Since specific acceptance criteria and detailed device performance are not explicitly stated in the provided text, the table below will reflect the information that is present:

Study Information

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

   • Sample Size: Not explicitly stated. The document mentions "System verification testing in a blood loop to simulate clinical use," but does not specify the number of blood samples, runs, or test conditions.
   • Data Provenance: Not explicitly stated, though the testing was described as "in a blood loop," implying an in-vitro or ex-vivo setting rather than live human subjects. This suggests controlled laboratory conditions. The country of origin for the data is not mentioned. It is a retrospective summary of testing performed for the 510(k) submission.

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

   • Not applicable/Not mentioned. The testing described is "System verification testing in a blood loop to simulate clinical use." This typically involves comparing the device's measurements against a reference method or standard in the blood loop, not against expert interpretation of data generated by the device itself. Therefore, ground truth would likely be established by precise laboratory reference measurements rather than expert consensus on device output.

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

   • Not applicable/Not mentioned. Adjudication methods are typically used in studies involving human interpretation (e.g., image reading) to resolve discrepancies. This study focuses on the technical performance of a monitoring device against reference values in a lab setting, where disagreement on "ground truth" (e.g., from a calibrated reference sensor) is not resolved by 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 is not relevant to this device. This device is a blood parameter monitoring system, not an AI-assisted diagnostic imaging or interpretation tool that assists human readers.

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

   • Since this is a monitoring device, its primary function is standalone performance (i.e., the accuracy of its measurements). The "System verification testing" would have assessed the standalone performance of the device in measuring blood parameters in a simulated environment. While not explicitly called "standalone performance," this is the nature of the testing described for such a device.

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

   • Based on the description "System verification testing in a blood loop to simulate clinical use," the ground truth would most likely be established by reference laboratory methods or highly accurate and calibrated reference sensors/analyzers used to measure the blood parameters (pH, pO2, pCO2, K+, SO2, Hct, Hgb, Temperature) in the blood loop. This ensures an objective and reliable comparison against the device's readings.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This is a monitoring device based on electro-optics modules, fluorescence chemistry, and optical reflectance technology, incorporating a microprocessor for calculations. It's not described as a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense (i.e., for supervised learning). While its internal algorithms and calibrations are developed, this typically involves engineering and validation against physical and chemical principles and reference standards, not a "training set" of patient data.

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

   • Not applicable for the reason given in point 7. For algorithms within such a device, "ground truth" during development would be established through meticulous engineering, physical modeling, chemical principles, and calibration against known standards and reference measurements.

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The 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 CDI™ System 500 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:

• CDI™ 500 Monitor
• Arterial and/or Venous Blood Parameter Modules (BPM)
• CDI™ Hematocrit/Saturation (H/S) Probe
• CDI™ 540 Gas Calibrator and Calibration Gases (A and B)
• CDI™ 510H Shunt Sensor
• Shunt Bypass Line
• CDI™ H/S Cuvette with or without extension tubing
• Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket)
• Printer Paper

The CDI™ System 500 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electrooptics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI™ 500 Monitor in real time, and displayed to the user via a graphical LCD display.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document describes a 510(k) submission for a modification to the Terumo CDI™ System 500, a blood parameter monitoring system. The core of this submission is to demonstrate substantial equivalence to a predicate device, specifically focusing on a design change to improve the robustness of the Blood Parameter Module (BPM) Probe Cable-Head against moisture ingress.

Therefore, the acceptance criteria and the study primarily revolve around verifying the effectiveness and safety of this specific design change, rather than proving performance metrics for all blood parameters. The document explicitly states: "This design change did not alter the device indication for use or performance specifications."

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the sample size used for the verification testing. It only generally refers to "Design control activities identified the requirements for the design change, which drove the design change verification activities."
• Data Provenance: Not specified. There is no mention of country of origin, or whether the study was retrospective or prospective. Given the nature of a design change verification, it would likely be prospective testing conducted in a controlled environment.

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

• The document does not mention the use of experts to establish ground truth for this specific verification testing. The testing appears to be objective engineering verification rather than a clinical study requiring expert interpretation of results.

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

• There is no mention of an adjudication method. This type of method is typically used in clinical trials where there's subjectivity in interpreting results and multiple readers are involved. For engineering verification of moisture ingress and function, such a method would not be applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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. This device is a blood parameter monitor; it does not involve AI or human interpretation of images or complex data in a way that would necessitate an MRMC study. The verification focuses on the hardware's robustness.

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

• This question is not applicable as the device is a measurement system, not an algorithm-based diagnostic or AI-driven tool. The "standalone performance" here refers to the device's ability to measure parameters, which is the inherent function it performs without human interpretation in the loop. The verification covered the robustness of a particular component.

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

• The ground truth for this design modification verification would be objective engineering measurements and functional tests. For example:
  • Functional performance: The device successfully provides accurate blood parameter readings after exposure to high humidity (ground truth derived from reference methods for blood gas analysis).
  • Safety: Absence of electrical malfunction or other hazards after moisture exposure (ground truth defined by safety standards and direct observation).
  • Expected life: The component continues to perform functionally for a defined duration under simulated conditions (ground truth against design durability specifications).
  • The document implies that the "predefined acceptance criteria" themselves represent the ground truth for success in these tests.

8. The sample size for the training set:

• This question is not applicable as the device is not an AI/ML model that requires a training set. The "design change" refers to a hardware modification, not a software algorithm that learns from data.

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

• This question is not applicable for the same reasons as #8.

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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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