(168 days)
ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least one year of age.
ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of:
- Minute Ventilation (MV)
- Tidal volume (TV)
- Respiratory rate (RR)
ExSpiron 1Xi measurements are used as an adjunct to other clinical information.
The ExSpiron 1Xi is a noninvasive respiratory monitoring system that graphically displays lung volume against time and reports Minute Ventilation, Tidal Volume and Respiratory Rate.
The ExSpiron 1Xi system consists of:
• Monitor:
The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure.
o Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC.
o Computer: A tablet PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate.
There are no hardware changes included in this submission.
Single-Patient Use ExSpiron Electrode PadSet:
• A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin. The Electrode PadSet for the ExSpiron 1Xi is identical to that cleared for the Predicate device.
The acceptance criteria and study proving the device meets them are summarized below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Equivalence to NM3 within) | Reported Device Performance (Mean Measurement Accuracy Error) |
|---|---|---|
| Minute Ventilation (MV) | +/- 10% | 11.9% |
| Tidal Volume (TV) | +/- 10% | 12.0% |
| Respiratory Rate (RR) | +/- 10% | 4.2% (0.6 breaths/min) |
Note: The document states that the equivalence tests rejected the null hypothesis that the ExSpiron 1Xi and NM3 have different mean values and concluded with 90% power that the measurements of MV, TV, and RR from the ExSpiron 1Xi and NM3 are equivalent within +/-10%. This indicates that the device met the acceptance criteria despite the accuracy error values being slightly outside the 10% for MV and TV in the table. The "accuracy error" values seem to represent the deviation, while the "equivalence tests" are the primary mechanism for meeting the criteria.
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: 72 pediatric patients.
- Data Provenance: Prospective observational study conducted at Children's Hospital of Boston, USA.
3. Number of Experts and Qualifications for Ground Truth:
- The study utilized continuous respiratory data collected simultaneously from the ExSpiron 1Xi and a monitoring spirometer (Philips NM3, referred to as the reference device) placed in the respiratory circuit. The NM3 itself essentially served as the "expert" ground truth (or established reference) in this comparative study.
- No human experts were explicitly mentioned as establishing a separate ground truth for the test set; the NM3 measurements were the reference.
- The qualifications of the individuals operating the devices or interpreting the NM3 data are not specified, beyond general "healthcare professionals."
4. Adjudication Method:
- No explicit adjudication method (like 2+1, 3+1) was mentioned. The study directly compared measurements from the ExSpiron 1Xi to the reference device (NM3).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- A MRMC comparative effectiveness study was not conducted in the context of human readers improving with or without AI assistance. This study was focused on the standalone performance of the ExSpiron 1Xi against a reference device, not on assisting human readers.
6. Standalone (Algorithm Only) Performance:
- Yes, a standalone study was performed. The clinical performance testing described is a standalone evaluation of the ExSpiron 1Xi's ability to measure MV, TV, and RR compared to a recognized reference device (Philips NM3) without a human-in-the-loop component.
7. Type of Ground Truth Used:
- The ground truth used was a reference device comparison. Specifically, the measurements from the Philips NM3 Respiratory Profile Monitor, a monitoring spirometer placed in the respiratory circuit, served as the reference standard for MV, TV, and RR.
8. Sample Size for the Training Set:
- The device's algorithm uses a "proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort."
- The exact sample size for the training set is not provided in the document, but it is described as a "large historical cohort."
9. How the Ground Truth for the Training Set Was Established:
- The document states that the software algorithm calculates respiratory parameters using a model "trained with a dataset containing respiratory data from a large historical cohort."
- It does not explicitly detail how the ground truth for this historical training dataset was established. However, given the context of a medical device measuring physiological parameters, it's highly probable that this training data would have been collected using established, accurate measurement methods, likely similar to (or including) reference spirometry or other validated respiratory monitoring techniques.
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).