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The CO2 Sidestream Module is designed to provide carbon dioxide monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Respiratory care. The CO2 Sidestream Module is used for adult patients.

The CO2 Sidestream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control. The operation of the CO2 Sidestream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the Module's memory. As the sample gas passes through a three-way valve, with the change of temperature and time, the valve leading to the pure air will close for 3-4 seconds to adjust the zero point. The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate for the calculation for the concentrations of carbon dioxide, which improves the design accuracy. The Module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). Respiration rate is calculated by measuring the time interval between detected breaths.

The provided text describes the acceptance criteria and a study demonstrating the device's compliance.

1. A table of acceptance criteria and the reported device performance

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

The document does not specify exact sample sizes for the performance tests (EtCO2, Respiration Rate). It mentions "See test report" for the test method, implying the full details are in separate reports (e.g., JJX-FDA-A/0-06-04, JJX-FDA-A/0-06-06, JJX-FDA-A/0-06-07) which are not provided.

For the biocompatibility tests:

• In Vitro Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity, Pyrogen Test: These tests were conducted on animal models (Guinea Pig, Rabbit) and in vitro (cell culture). Specific numbers of animals or cell cultures are not explicitly stated in this summary but are implied by the nature of these standardized tests.
• Emissions and Leachables: These tests analyze the device materials themselves rather than patient samples.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of performance validation tests (e.g., accuracy, stability, electromagnetic compatibility) using standard methods and controlled environments, these are generally prospective and performed in a laboratory setting. Biocompatibility tests are also typically conducted in labs.

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

Not applicable. The reported performance relates to the device's adherence to specified technical standards for measurement accuracy and safety, rather than interpretations by medical experts to establish a "ground truth" for diagnostic or clinical purposes. The ground truth for EtCO2 and Respiration Rate accuracy is established against highly accurate reference measurement systems in a laboratory setting. For biocompatibility, ground truth is established by standardized biological assays.

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

Not applicable. This device is a CO2 Sidestream Module measuring physiological parameters. The testing described is performance verification against technical standards, not involving human interpretation or adjudication of clinical outcomes.

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

Not applicable. This device is a measurement module, not an AI-assisted diagnostic tool where human readers would interpret results.

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

Yes, the performance data presented (EtCO2, Respiration Rate accuracy, biocompatibility, EMC, etc.) are for the device (CO2 Sidestream Module models Capno-S, Capno-S+) operating standalone in controlled test environments. The device itself is designed to be a component of a host monitoring system, meaning its internal function and measurements are "standalone" in the sense of not requiring human-in-the-loop for its basic operation and data generation. It outputs data which the host monitor then displays.

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

The ground truth for the technical performance data (EtCO2 and Respiration Rate accuracy) would be based on highly accurate reference measurement devices in a controlled laboratory setting (e.g., calibrated gas mixtures for CO2 concentration, precise timing mechanisms for respiration rate). For biocompatibility, the ground truth is determined by the results of standardized biological and chemical tests as defined in the ISO 10993 and ISO 18562 series.

8. The sample size for the training set

Not applicable. This device is a measurement instrument, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as no training set was used.

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The CO2 Mainstream Module is intended to provide carbon dioxide monitoring system during anesthesia/recovery, in Emergency Medicine/Transport or Respiratory care.
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a monitoring system during anesthesia/recovery in host Emergencv Medicine/Transport or Respiratory care.
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care.

The CO2 Mainstream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control.
The operation of the CO2 Mainstream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the module'smemory.
The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate the calculation for the concentrations of carbon dioxide, which improves the design accuracy.
The module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). In addition, a CO2 waveform (Capnogram) may be displayed, which is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the time interval between detected breaths.
The differences between the Capno M and M+ are only with the intended patient type. The Capno M is intended for use on intubated patients, where the Capno M+ is intended for use with intubated and non-intubated patients. The operating principles, unit of measurement, ETCO2 measurement range, accuracy, respiration rate range, and respiration rate accuracy are the same for both devices.

The CO2 Mainstream Module (Capno-M and Capno-M+) is a device intended to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/Transport or Respiratory care. The device's performance was evaluated through non-clinical studies covering electrical safety, electromagnetic compatibility (EMC), and specific performance criteria in accordance with ISO 80601-2-55. No clinical studies were performed.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated for each performance test. The document refers to "bench testing for Inspired CO2 range and accuracy, and Respiration rate range and accuracy." This implies laboratory testing on a device unit or units.
• Data Provenance: The tests conducted appear to be non-clinical bench tests performed by the manufacturer, Beijing Kingst Commercial & Trade Co., Ltd., to demonstrate compliance with international standards. No information regarding country of origin for the data or whether it was retrospective or prospective is provided, as it is non-clinical bench testing.

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

• Not applicable. The ground truth for the performance tests (e.g., CO2 concentration, respiration rate) would have been established by calibrated laboratory equipment and reference gases/controlled conditions as per the ISO 80601-2-55 standard, not by human expert assessment.

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

• Not applicable. As this involves non-clinical bench testing for performance and safety, human adjudication methods like 2+1 or 3+1 are not used. Compliance is typically determined by directly comparing device output to known inputs and standard requirements.

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:

• No. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a CO2 mainstream module, which is a sensor for measuring carbon dioxide, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

• Yes, in essence. The performance data presented is for the device operating as a standalone sensor (without human interpretation or assistance as part of the primary measurement function). The device's accuracy and range in measuring CO2 and respiration rate are intrinsic to the device's technical specifications.

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

• For CO2 and respiration rate measurements, the ground truth would be established through calibrated reference standards and controlled experimental conditions as specified by the relevant testing standards (e.g., ISO 80601-2-55). This involves using known concentrations of CO2 gases and controlled airflow patterns to simulate breathing.

8. The sample size for the training set:

• Not applicable. This device is a hardware sensor, not a machine learning or AI algorithm that requires a training set of data.

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

• Not applicable, as there is no training set for this type of device.

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