(259 days)
ExSpiron is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years of age) patients.
ExSpiron is a non-invasive system that graphically displays lung volume against time and reports an approximate value of:
- Tidal volume, .
- . Respiratory rate, and
- Minute ventilation. ●
ExSpiron measurements are used as an adjunct to other clinical information sources.
The ExSpiron™ consists of:
Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC.
Panel PC: A Windows 7 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 volume, tidal volume, and respiratory rate.
Single Patient Use ExSpiron™ Electrode Lead Set: An electrode lead set containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode lead set is also used to perform subsystem checks prior to patient measurements.
The provided 510(k) summary for the ExSpiron™ device includes information about its acceptance criteria and the study performed to demonstrate its performance.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the calculation of bias and accuracy. The specific pass/fail thresholds for these metrics are not explicitly stated as "acceptance criteria" but are presented as the device's performance against a reference.
| Metric | Acceptance Criteria (Implied by Predicate Comparison) | Reported ExSpiron™ Performance (vs. Wright spirometer) | Reported ExSpiron™ Performance (Calculated vs. Morgan diagnostic spirometer) |
|---|---|---|---|
| Minute Ventilation | Expected to be comparable to predicate (Wright spirometer and indirectly Morgan diagnostic spirometer) | Bias: -2.1% (Overall), -2.3% (Day 1), -1.9% (Day 2) | |
| Accuracy: 10.7% (Overall), 10.4% (Day 1), 10.9% (Day 2) | Bias: -1.7% | ||
| Accuracy: 9.9% | |||
| Tidal Volume | Expected to be comparable to predicate (Wright spirometer and indirectly Morgan diagnostic spirometer) | Bias: -1.9% (Overall), -1.7% (Day 1), -2.0% (Day 2) | |
| Accuracy: 10.4% (Overall), 9.8% (Day 1), 11.0% (Day 2) | Bias: -1.5% | ||
| Accuracy: 9.6% | |||
| Respiratory Rate | Expected to be comparable to predicate (Wright spirometer) | Bias: -0.2% (Overall), -0.6% (Day 1), 0.2% (Day 2) | |
| Accuracy: 2.0% (Overall), 2.4% (Day 1), 1.6% (Day 2) | N/A (Not directly compared to Morgan for RR) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for ExSpiron-Wright study: 20 subjects
- Sample Size for Wright-Morgan study: 20 subjects (a different set of subjects)
- Data Provenance: The document does not explicitly state the country of origin, but it is a 510(k) submission to the FDA, suggesting the study was conducted to support US market approval. The study design (clinical comparison) implies prospective data collection for the purpose of the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a measurement device, and its performance is compared directly against existing medical devices (Wright spirometer and Morgan SpiroAir LT diagnostic spirometer), which are considered the reference or "ground truth" for these measurements. There is no mention of human experts establishing ground truth for individual measurements.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth was established by direct measurement from predicate devices, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The ExSpiron™ is a medical device for monitoring physiological parameters (tidal volume, minute ventilation, respiratory rate), not an AI-powered diagnostic tool for interpretation by human readers. Therefore, an MRMC study or AI assistance effect size is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the clinical performance testing describes a standalone assessment of the ExSpiron™ device. Its measurements were compared directly and simultaneously with those from the predicate devices (Wright spirometer and, indirectly, Morgan diagnostic spirometer). The output of the ExSpiron (tidal volume, minute ventilation, respiratory rate) is generated solely by the device based on its bioimpedance measurements and internal algorithms, without human intervention in the measurement process itself.
7. The Type of Ground Truth Used
The ground truth used was measurement from predicate medical devices:
- Wright spirometer: for tidal volume, minute ventilation, and respiratory rate. Respiratory rate was calculated using a stopwatch in conjunction with the Wright spirometer.
- Morgan SpiroAir LT diagnostic spirometer: for tidal volume and minute ventilation in a separate comparative study with the Wright spirometer. This allowed for an indirect comparison between the ExSpiron and the Morgan device.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. The ExSpiron™ uses a "Bioimpedance measurement system" with "Firmware performs signal acquisition and relays data to the panel PC. Panel PC: A Windows 7 PC performs signal processing and calibration." It also states "the ExSpiron was calibrated to the individual" in the clinical study. This suggests a traditional signal processing approach with individual calibration, rather than a large dataset-based machine learning training paradigm. Therefore, a specific "training set sample size" as understood in AI development is not provided or likely applicable in the conventional sense for this device.
9. How the Ground Truth for the Training Set was Established
Similar to the point above, a traditional "training set ground truth" is not explicitly described. Instead, the device undergoes individual calibration for each subject against known physiological signals or reference measurements at the time of use. The clinical study details that "electrodes were applied, the ExSpiron was calibrated to the individual, and each subject performed ten 60-second breathing tests." This initial calibration likely establishes the individual's baseline and correlation for the bioimpedance measurements before subsequent monitoring.
§ 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).