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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.

Ask a specific question about this device

The intended use of the M4 Monitor is for the non-invasive continuous monitoring of O2 saturation, hematocrit and haemoglobin concentration, blood flow, gaseous emboli, Temperature, PO2, and PCO2, 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 M4 Monitor consists of a 10.4 inch high definition touch screen and sensor assemblies connected to a flat panel display unit. Optical sensor assemblies are used to collect data for the measurement of Arterial and Venous Saturation and Hot / Hb. Ultrasonic sensors are used to collect data for the measurement of flow and gaseous emboli. A thermistor is used for the collection of temperature data. Inlet and outlet gas measurements sensors are used to collect data for the measurement of PO2, and PCO2.

Parameter values are displayed in both a digital and trended format. The M4 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, via a RS232 link or wirelessly to a remote computer.

The M4 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 K110957 describes a medical device called the "M4 Monitor" and its substantial equivalence to predicate devices, but it does not contain any information about specific acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results with acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions regarding sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for the M4 Monitor based on the provided text.

The closest information available is a general statement about performance:

"Performance data has been provided to show that the revised M4 Monitor can measure the oxygen saturation, hematocrit / haemoglobin concentration, blood flow, gaseous emboli, Temperature, PO2, and PCO2."

This statement confirms that performance data was provided to the FDA, but the content of that data, including specific acceptance criteria or study methodologies, is not detailed in this 510(k) summary.

Ask a specific question about this device

The intended purpose of the MAQUET Blood Monitoring Unit BMU 40 is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (Ta and Tv), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct). Oxygen consumption (VO2) can also be calculated. Blood flow (QBlood) can be entered manually or values can be received from a connected heart-lung machine.

The duration of application of the disposable products (arterial BMU Sensor and venous BMU Cell) is limited to six hours.

The BMU 40 is designed for continuous operation.

The Blood Monitoring Unit BMU 40 monitors blood parameters during cardiopulmonary bypass or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters

The Blood Monitoring Unit BMU 40 is blood monitoring system consisting of the following componens:

• the control unit (monitor, called BMU 40) which comprises a display i showing the actual measured sensor values and time course.
• Sterile single use connectors (BMU Sensor/ BMU Cell) to be clamped י on the probes, one in the venous line and one in the arterial line. The connectors are available in different sizes. BMU Sensor is connected to arterial probe and BMU Cell is connected to venous probe.

The provided text describes a medical device, the MAQUET Blood Monitoring Unit BMU 40, and its 510(k) submission for substantial equivalence. However, it does not contain the specific details about acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study in the format requested.

The document states that the performance characteristics of the BMU 40 were exhaustively tested and compared with the predicate device (CDI 500) and that the device performs as intended according to its performance specifications. It also lists areas that were tested such as "Performance", "Electrical and mechanical safety", "Software Validation", "Biocompatibility", "Sterility", and "Integrity".

Therefore, I cannot provide the requested table or detailed information about the study because the source document does not contain this level of detail.

The information provided only confirms that:

• The device is intended to monitor blood parameters during cardiopulmonary bypass.
• It was compared to predicate devices (CDI Blood Parameter Monitoring System 500 and M3 Monitor) for substantial equivalence in intended use, design, and performance.
• Testing was performed to demonstrate safety and effectiveness.

To answer your request, specific performance specifications and the results of those tests would be required, which are not present in the provided text.

Ask a specific question about this device