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The Metaphor uses the direct measurement of Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise. The Metaphor can assess energy expenditure to support nutritional assessment. Optional measurement of Nitrous Oxide (N2O) is available for enhanced accuracy of the CO2 measurement in the presence of N2O.

The Metaphor is a comprehensive pulmonary mechanics monitor which can display graphic and numeric data in patients who are mechanically ventilated or breathing spontaneously.

The Metaphor pulse oximetry function provides continuous SpO2 and pulse rate measurements in neonatal through adult populations with appropriate probes.

The Metaphor provides adjustable visible and audible alarms. The device is not intended for use as a transport monitor.

The Metaphor Metabolic Monitor integrates the functions of a sidestream respiratory gas monitor (CO2, O2, N2O), and pulmonary mechanics monitor (pressure, flow, and volume). These features allow the Metaphor to measure Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise.

The system is comprised of two main elements:

• Metaphor PC software host application running on a dedicated touch screen computer terminal, which presents computed physiological monitoring parameters, including metabolic measurements, as graphic and numeric data. This application manages the user interface, including alarms, and it interfaces to the BXB_DAS.
• The BXB DAS embedded measurement platform this subsystem contains the sensor technology to perform the gas, pressure, and flow measurements, and integrates a 510(k) cleared third party pulse oximeter module. The BXB DAS subsystem interfaces with single patient use EZ-Flow sensors and SpO2 sensors.

This summary describes the acceptance criteria and the study that proves the Metaphor Metabolic Monitor meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated for any specific test. The document refers to various "tests" and "testing" without providing breakdowns of the number of samples or cases used.
• Data Provenance: The study was a non-clinical evaluation. No human patient data (retrospective or prospective) was used for performance validation. The testing involved bench tests, simulations, and conformance to electrical and material standards. This suggests the data was generated in a lab setting by the manufacturer, TreyMed, Inc., located in Sussex, Wisconsin, USA.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. Since this was a non-clinical study involving bench testing and conformance to standards, there was no ground truth established by medical experts for diagnostic or clinical performance claims. The performance was assessed against engineering and safety standards.

4. Adjudication Method for the Test Set

• Not Applicable. No clinical test set or expert-driven adjudication was performed as part of this submission. The tests were objective engineering and safety evaluations against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states "Clinical Tests Submitted: (none)". Therefore, no MRMC study or AI-assisted human reader improvement was assessed or reported. This device does not involve image interpretation or diagnostic decisions that would typically necessitate such a study.

6. Standalone Performance Study

• Yes, in the context of a non-clinical device. The described testing largely represents standalone performance of the algorithm and hardware components (e.g., flow measurement, gas monitoring, pulse oximetry integration, software verification) against engineering standards and specified performance criteria. The device's various functions (e.g., measuring VO2, VCO2, CO2, O2, N2O, SpO2, and pulmonary mechanics) were tested for their inherent accuracy and functionality in a non-clinical setting.

7. Type of Ground Truth Used

• The "ground truth" for these non-clinical tests was based on engineering standards, predetermined specifications, and comparison to calibrated reference instruments or simulation data where applicable (e.g., pulse oximeter simulation). For example, electrical safety adherence is measured against established electrical safety standards, and gas concentration measurements would be validated against known gas mixtures.

8. Sample Size for the Training Set

• Not applicable / Not specified. This device is a metabolic monitor, not a machine learning or AI-driven diagnostic system that typically requires a 'training set' in the conventional sense of supervised or unsupervised learning from clinical data. The software was "verified to requirements" and "validated to meet intended use," which refers to standard software development and testing practices, not machine learning model training.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As described above, there was no 'training set' in the context of machine learning. The device's functionality is based on established physical and chemical principles of measurement and data processing. The "ground truth" for the development of its software and hardware components would have been derived from physical laws, engineering specifications, and validated measurement techniques.

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