Search Results

The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.

At-rest patient measurements are obtained in a spot-check measurement session lasting approximately two minutes, using specified accessories which include a single patient use breathing gas mouthpiece, a single patient use nose clip, and a reusable pulse oximeter finger sensor.

The device is indicated for use by qualified medical personnel in professional healthcare facilities on conscious and cooperative patients who are eighteen (18) years and older. The GEM is not to be utilized simultaneously with supplemental Oxygen nor with other respiratory gases or agents.

The MediPines Gas Exchange Monitor (GEM) is not intended to be used as the sole basis for making diagnosis or treatment decisions related to patient gas exchange; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. It is not intended to replace arterial blood gas sampling for treatment purposes.

The Gas Exchange Monitor (GEM) is a non-invasive multi-parameter respiratory monitoring system that uses at-rest spot check breath samples to provide respiratory measurements of oxygen (PO₂, ETO₂) and carbon dioxide (PCO₂, ETCO₂) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices to assess a patient's respiratory status.

The device utilizes a single patient use disposable mouthpiece attached to the monitor via a tubing system and an attached pulse oximetry probe. A nose clip is used during the measurement session and real-time tracing of breath samples are displayed on the device screen and may be exported as PDF and image files.

Here's a breakdown of the acceptance criteria and study information for the MediPines Gas Exchange Monitor (GEM), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides specific accuracy criteria for CO2 and O2 measurements, and SpO2/Pulse rate.

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

The document mentions "Controlled hypoxia test results were obtained in human adult volunteers" for SpO2 accuracy.

• Sample Size: Not explicitly stated.
• Data Provenance: Prospective, controlled clinical study in human adult volunteers. The country of origin is not specified.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. However, the ground truth for SpO2 was determined by "arterial oxygen saturation (SaO2) as determined by co-oximetry," which suggests a reliance on a gold-standard laboratory method rather than expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable as the ground truth for physiological parameters (like SaO2 via co-oximetry) is often established by a direct measurement method rather than expert interpretation needing adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a physiological monitor, and its accuracy is assessed against reference standards rather than human reader performance.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the described tests for CO2, O2, SpO2, and Pulse Rate accuracy are all standalone performance evaluations of the device's ability to measure these parameters against a reference/ground truth. The clinical studies were conducted to "assess the operation" and support "accuracy claims" of the device itself.

7. Type of Ground Truth Used

• Ground Truth Type:
  • SpO2: Arterial oxygen saturation (SaO2) as determined by co-oximetry (considered a gold standard for blood gas measurement).
  • CO2, O2, Pulse Rate: Not explicitly stated, but typically these are validated against highly accurate reference gas analyzers or calibrated physiological simulators. The document refers to "test levels" for standards (ISO 80601-2-55 for respiratory gas monitors and ISO 80601-2-61 for pulse oximeters), implying a reliance on established reference methods and simulators.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The document describes verification and validation for software (IEC 62304) and hardware performance testing. This is a medical device that makes direct measurements, not a machine learning or AI-driven diagnostic system that typically requires a 'training set' in the conventional sense.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine-learning algorithm. The device's functionality is based on established physical principles of gas analysis (Non-dispersive Infrared for CO2, galvanic cell for O2) and pulse oximetry (two-wavelength pulse measurement).

Ask a specific question about this device