Search Results

The Virtus Metabolic Monitor is indicated for the measurement of Resting Energy Expenditure (REE) for mechanically ventilated patients, who are non-spontaneous breathing, and who are at least 18 years of age.

The Virtus Metabolic Monitor is intended to be used in Intensive Care Units (ICUs) in professional healthcare facilities only.

The Virtus Metabolic Monitor is for prescription use only.

Virtus Metabolic Monitor is a metabolic monitors designed for the measurement of resting energy expenditure (REE) for mechanically ventilated adult patients in the Intensive Care Unit (ICU).

The device is enclosed in a metal casing with a color touch screen on front for user interaction and measurement results. On the left-hand side pneumatic connections to the flow and gas sensor (Flow Sensor) and on the rear the mains power inlet, on-switch, charging indicator and USB-connector for export of results.

The Virtus Metabolic Monitor is portable and is supplied from the built-in battery or from mains, where it is automatically charged.

Here's a breakdown of the acceptance criteria and study information for the Virtus Metabolic Monitor, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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

The document describes a "side-by-side" test against the predicate device. However, the specific sample size for this test set (number of measurements, number of patients) is not provided. The data provenance (country of origin, retrospective/prospective) is also not explicitly stated. It's implied to be a testing scenario rather than a clinical study on patients, given the wording.

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

The document does not mention the use of experts to establish ground truth for this non-clinical, side-by-side comparison test. The comparison was made against the measurements of a cleared predicate device (Cosmed Q-NRG+).

4. Adjudication Method for the Test Set

Since the ground truth was established by comparison to a predicate device's measurements in a laboratory setting, there was no expert adjudication method described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The described testing is a non-clinical side-by-side comparison of device measurements, not a study involving human readers or their improvement with AI assistance.

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

Yes, the described testing is a standalone performance evaluation of the Virtus Metabolic Monitor. It directly compares the device's measurements (V'O2, V'CO2, REE) against those of a predicate device in a controlled setting, without a human-in-the-loop context.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical side-by-side test was the measurements provided by the predicate device (Cosmed Q-NRG+). The study aimed to show "acceptable agreement of measurements between the subject device and the predicate device."

8. The Sample Size for the Training Set

The document does not mention any training set or related sample size. The device calculates metabolic parameters using the standard Weir formula and relies on measured V'O2 and V'CO2. There's no indication of a machine learning-based algorithm requiring a training set in this summary.

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

As no training set is mentioned or implied, the method for establishing its ground truth is not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device