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The Capnograph and Oximeter is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.

The Capnograph and Oximeter is intended for use in adults in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.

This device is used to monitor up to four physiological parameters for the patient at the same time: End tidal CO2 concentration (EtCO2), Respiration Rate (RR), functional Oxygen Saturation (SpO2) and Pulse Rate (PR). The monitor can be purchased having functions with two or more of the parameters mentioned above, but the manual can be used for the device in any configuration.

The Capno-H uses an infrared absorption method to measure in a sidestream or Mainstream mode. The measurement parameters are EtCO2, InsCO2 and Respiration Rate. InsCO₂, also called FiO₂ is the fraction of oxygen in the volume being measured. The CO2 response time is Sidestream:

The provided text describes the acceptance criteria and study for the CMI Health Inc. Capnograph and Oximeter, Model Capno-H (K170820).

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance are primarily based on equivalence to a predicate device (Shenzhen Creative Industry Co., Ltd, Vital Signs Monitor, Model PC-900A, K093016) and compliance with various international standards. The document explicitly states: "All of the pre-determined acceptance criteria were met."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify human clinical trials or a "test set" in the context of diagnostic accuracy for the entire device. The performance data for SpO2 and CO2 accuracy are stated as ranges and thresholds without detailing specific patient data used for testing.

• SpO2 module: The document states that the Capno-H uses the "PC-60 SpO2 module cleared in K063641" and that "the sensors were clinically validated and intended to be used in K063641." This implies that the clinical validation for SpO2 accuracy was conducted as part of the K063641 submission, not for the current device directly. The provenance of that original SpO2 clinical validation data (K063641) is not provided in this document.
• CO2 module: The CO2 accuracy is presented as fixed ranges (e.g., ±2mmHg for 0-40mmHg). It mentions compliance with ISO 80601-2-55 (which governs respiratory gas monitors) and that the CO2 module (CapnoCore) uses the non-dispersive infrared gas (NDIR) technology. However, no specific details about a clinical test set (sample size, provenance) for CO2 accuracy are provided in this document for either the Capno-H or its CapnoCore module.
• Type of Study: The primary "study" described is a comparison to a predicate device and compliance with established performance and safety standards. This is a bench and engineering testing-based assessment rather than a typical clinical study with a specified "test set" of patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document does not describe a clinical study where experts established ground truth for a test set. The accuracy claims are numerical specifications that are likely verified through device calibration and bench testing against known gas concentrations or established reference devices/methods for SpO2.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring expert adjudication is described.

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 an oximeter and capnograph, not an AI-powered diagnostic imaging device involving human readers or interpretation of complex medical cases.

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

This device appears to be a standalone measurement device. Its performance specifications (e.g., SpO2 accuracy, EtCO2 accuracy) are inherently "standalone" in that they describe the device's direct measurement capability, without an AI component or complex human-in-the-loop interaction in its core function of displaying vital signs. The device is intended for "regular supervision of clinical personnel," but this refers to its clinical use, not the intrinsic performance validation of the measurement algorithms.

7. The Type of Ground Truth Used

The ground truth for the performance specifications (EtCO2, SpO2, Pulse Rate, Respiration Rate) would have been established using:

• Reference Standards/Known Concentrations: For CO2 accuracy, gas mixtures with precisely known CO2 concentrations would be used in bench testing.
• Reference Oximeters/Co-oximeters: For SpO2 accuracy, reference co-oximeters are typically used (e.g., during induced hypoxia studies) to establish arterial oxygen saturation (SaO2) values for comparison. The document clearly refers to "clinically validated" sensors in the SpO2 module (from K063641), implying such studies occurred for that module.
• Controlled Measurements: For pulse rate and respiration rate, comparison with ECG or manual counts, or simulated physiological signals, would likely be the ground truth.

8. The Sample Size for the Training Set

Not applicable. This document describes a traditional medical device, not an AI/machine learning algorithm that requires a "training set." The device's algorithms for calculating SpO2, CO2, etc., are based on established physiological principles and signal processing, not on training data in the AI sense.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for an AI algorithm.

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