(281 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 adult (at least 21 years old) patients.
ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of:
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Minute Ventilation (MV)
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Tidal volume (TV)
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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.
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. 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.
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.
Acceptance Criteria and Device Performance for ExSpiron™ 1Xi
1. Table of Acceptance Criteria and Reported Device Performance
The provided document compares the proposed device (ExSpiron 1Xi) to a predicate device (ExSpiron™ 1Xi, K130170). The comparison focuses on various characteristics, including accuracy. While explicit "acceptance criteria" for accuracy are not stated as numerical thresholds, the document presents the accuracy results of the proposed device. The implied acceptance is that the proposed device performs at least as well as, or better than, the predicate device.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Proposed ExSpiron 1Xi) |
|---|---|---|
| Accuracy | ||
| Minute Ventilation (MV) | 10.7% | 11.5% (Overall) |
| Tidal Volume (TV) | 10.4% | 11.4% (Overall) |
| Respiratory Rate (RR) | 0.1% | 0.08% (Overall) |
| Bias | (Not explicitly stated for predicate) | MV: 2.2%, TV: 2.2%, RR: 0.01% (Overall) |
| Precision | (Not explicitly stated for predicate) | MV: 7.0%, TV: 6.9%, RR: 0.08% (Overall) |
| Intended Use | Identical to predicate | Identical to predicate |
| Technology | Thoracic bioimpedance | Thoracic bioimpedance |
| Volume Measurements | Tidal volume, Minute volume, Volume vs. time chart | Tidal volume, Minute volume, Volume vs. time chart |
| Rate Measurements | Respiratory rate (breaths/min) | Respiratory rate (breaths/min) |
| Safety | IEC 60601-1 compliant | IEC 60601-1 compliant |
| Energy Source | Low current signal at approximately 50 kHz | Low current signal at approximately 50 kHz |
| EMC/EMI Compliance | IEC 60601-1-2 compliant | IEC 60601-1-2 compliant |
| Electrode PadSet | Single-patient use, biocompatible, printed padset | Single-patient use, biocompatible, printed padset |
| Impedance Measurement Range | 15 Ohms to 180 Ohms | 15 Ohms to 180 Ohms |
| Biocompatibility | Electrode PadSet is biocompatible; Monitor and Patient Cable not for patient contact | Electrode PadSet is biocompatible; Monitor and Patient Cable not for patient contact |
| Usability | ISO 60601-1-6 compliant (with calibration) | ISO 60601-1-6 compliant (without calibration in Basic Monitoring mode) |
The document notes that the "algorithm was refined for the ExSpiron 1Xi using thousands of additional data points collected over the last 3 years in a wide variety of patient populations," leading to "more accurate respiratory volumes than the predicate." However, the accuracy percentages show a slight decrease in accuracy (higher percentage value) for MV and TV compared to the predicate in this summary document. This might be due to presenting overall clinical study results for the proposed device, while the predicate's numbers might be from a specific lab setting or a different calculation method for its initial clearance. The conclusion explicitly states the proposed device "is as safe and as effective as the predicate."
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 20 subjects
- Age range: 22-80
- BMI range: 19-42
- Gender: 9 female, 11 male
- Data Provenance:
- Country of Origin: Waltham, MA, USA (clinical study conducted there)
- Retrospective or Prospective: Prospective. The study was conducted specifically to compare simultaneous measurements from the ExSpiron 1Xi and the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish the ground truth for this clinical study, nor does it specify their qualifications. The study focused on comparing the performance of the proposed device against a predicate device through simultaneous measurements. This implies the predicate device's measurements or another recognized standard served as the comparative reference, rather than a separate "ground truth" established by experts for each breath.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. It states that simultaneous measurements were taken from both the proposed device and the predicate device, implying a direct comparison rather than a need for expert adjudication of independent measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical study comparing simultaneous measurements of the proposed device and a predicate device on patients, not a study evaluating human reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance aspect is implied. The "Accuracy" section of the comparison table and the clinical study results (Bias, Precision, Accuracy) directly assess the performance of the device's algorithms in measuring respiratory parameters (MV, TV, RR) without explicitly mentioning human intervention in the real-time measurement process. The device provides "approximate values" of these parameters.
7. Type of Ground Truth Used
The ground truth for the clinical study was established by simultaneous measurements from a legally marketed predicate device (ExSpiron™ 1Xi, K130170). The study aimed to show equivalence or improvement compared to an already cleared device.
8. Sample Size for the Training Set
- The predicate device's algorithm was "trained with a dataset containing respiratory data from a large historical cohort."
- The proposed device's algorithm was "refined for the ExSpiron 1Xi using thousands of additional data points collected over the last 3 years in a wide variety of patient populations." The exact numerical sample size ("thousands") is not specified beyond this qualitative description.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly detail how the ground truth for the "large historical cohort" or the "thousands of additional data points" used for algorithm training/refinement was established. However, given the nature of a spirometer, it is highly probable that the ground truth for training data would have been established using:
- Reference Spirometry: Directly measured, highly accurate respiratory volumes and rates from calibrated gold-standard spirometry equipment.
- Other established physiological measurement techniques that provide accurate respiratory parameters.
The purpose of the training data is to allow the device's proprietary, non-linear, regressive model to accurately calculate respiratory parameters "without patient-specific calibration" for the proposed device.
§ 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).