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The Respiree Cardio-Respiratory Monitor is a respiratory monitor intended for hospital-type facilities in non-ICU settings. The Respiree Cardio-Respiratory Monitor is indicated for the non-invasive spot checking of respiration rate (RR) for adult patients.

The Respiree Cardio-Respiratory Monitor, Model RS001, is a small respiratory monitor. For measurement of respiration rate (RR), the device is affixed to the chest using a disposable adhesive patch with a hook-and-loop fastener to attach to the monitor. The device uses a vertical-cavity surface-emitting diode to emit optical radiation directed toward the skin. An integrated photodetector in a nearby position senses the diffused collected light. An adaptive signal processing method is used to enhance the device respiratory rate measurements by splitting the signal processing optimizations across different respiratory rate bands.

The monitor is powered by a 3.7V rechargeable, lithium-ion battery and a USB charging cable is provided. The Respiree Cardio-Respiratory Monitor also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile devices.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: 46 subjects
• Data Provenance: The document does not explicitly state the country of origin.
• Retrospective/Prospective: The study was a clinical validation, which typically implies a prospective design where the device is used to collect new data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: The document states the reference EtCO2 waveform was "manually scored by counting the respiratory peaks per minute." It does not specify the number of experts.
• Qualifications of Experts: The qualifications of the individuals who performed the manual scoring are not specified in the provided text.

4. Adjudication Method for the Test Set

• The document implies that the ground truth was established by manual scoring of the EtCO2 waveform. It does not describe an adjudication method (such as 2+1 or 3+1 consensus) for this manual scoring.

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

• No, an MRMC comparative effectiveness study was not done. The study described compared the device's performance against a reference standard (EtCO2 waveform) and did not involve human readers using or not using AI.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone study was done. The clinical validation was conducted to assess the performance of the Respiree Cardio-Respiratory Monitor device itself in measuring respiratory rate, comparing its output directly to a reference standard.

7. Type of Ground Truth Used

• The ground truth used was the EtCO2 waveform manually scored by counting the respiratory peaks per minute. This can be categorized as a type of expert-derived physiological measurement.

8. Sample Size for the Training Set

• The document does not specify the sample size for the training set. It only describes the clinical validation study (test set).

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

• As the training set size is not specified, the method for establishing its ground truth is also not provided in the given text.

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