(244 days)
The LuMon™ System is a noninvasive, non-radiation device that provides information on regional impedance variation within a cross-section of a patient's thorax. Graphical and numerical information is presented to the user as an adjunctive tool to other clinical information to support the user to assess a patient's respiratory condition.
The LuMon™ System is indicated for neonatal and infant patients with chest circumferences between 16.5 - 50 cm and adolescent through adult patients with chest circumferences between 76 - 128 cm who are breathing spontaneously or require mechanical ventilation in professional healthcare facilities.
Impedance-based respiratory rate monitoring is indicated for adults 22 years and older whose chest circumference is above 76 cm only.
The LuMon™ System also displays selected physiological and respiratory parameters from supported bedside devices.
The LuMon™ System does not measure regional ventilation of the lungs.
The LuMon™ System is a compact and lightweight Electrical Impedance Tomography (EIT) system that provides noninvasive monitoring of variations of regional air content/volume within a cross-section of the patient's thorax and patient respiration. It displays the results as real-time EIT images, waveforms, and derived parameters.
The system consists of a controller display unit, signal acquisition connector cable, and patient-applied conductive textile electrode belts. The system can connect to external bedside devices such as ventilators and monitoring devices to display contextual information for interpretation of EIT measurements.
The provided FDA 510(k) clearance letter and summary for the LuMon™ System contains information regarding its acceptance criteria and the studies conducted to demonstrate its performance. However, some specific details commonly found in a comprehensive study report (e.g., exact sample size for each clinical study, number of experts for ground truth, adjudication methods beyond "clinician-scored") are not explicitly stated in this high-level summary.
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Acceptance Criteria and Device Performance for LuMon™ System
The LuMon™ System underwent extensive non-clinical (bench and pre-clinical) and clinical testing to demonstrate its safety and effectiveness. The acceptance criteria are implicitly defined by the performance characteristics presented in the comparison tables and the successful attainment of stated accuracies and correlations.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established as equivalent to or better than the predicate/reference devices, or as meeting pre-defined tolerances for specific parameters.
| Acceptance Criteria Category | Specific Metric/Parameter | Acceptance Criteria/Target (Implicit or Explicit) | Reported Device Performance (LuMon™ System) |
|---|---|---|---|
| Regional Impedance Distribution | EIT to CT R-squared correlation (Right lung) | Excellent correlation (implicitly, near 1.0) | 0.98 |
| EIT to CT R-squared correlation (Ventral lung) | Excellent correlation (implicitly, near 1.0) | 0.97 | |
| EIT to CT Bias and Precision (Right & Ventral lung) | Within pre-defined tolerance (explicit) | Well within pre-defined tolerance | |
| Respiration Rate (RRi) | Accuracy for Adults (5-60 bpm) | ± 2 bpm (explicit) | ± 2 bpm over 5-60 bpm |
| Global Volume Changes | Agrees with Body Plethysmograph and Ventilator flow-sensed volumes | Not explicitly quantified, but "validated the ability" (implicit good agreement) | Validated against Body Plethysmograph and Ventilator flow-sensed volumes. |
| End-Expiratory Lung Impedance (EELI) | Uncertainty of reading | +/- 10% of reading | +/- 10% of reading |
| Tidal Variation Z (TVz) | Uncertainty of reading | +/- 10% of reading | +/- 10% of reading |
| Distribution Ratios (Anterior, Posterior, Left, Right) | Uncertainty | +/- 10 p.p. | +/- 10 p.p. |
| Patient Position Measurement Validation | System's ability to account for gravity/orientation | Implied successful operation | Yes, continuous and automatic measurement and display. |
| Signal to Noise Ratio (SNR) | Not explicitly stated as "acceptance criteria," but comparison with predicate | Typically, higher SNR is better. Predicate: 50-95 dB | Min-Max (Mean): 45.0 – 84.9 (62.2) dB |
| Voltage Accuracy | Not explicitly stated as "acceptance criteria," but comparison with predicate | Predicate: 80-100% | Min-Max (Mean): 91.1 - 100.0 (99.1)% |
| Reciprocity Accuracy | Not explicitly stated as "acceptance criteria," but comparison with predicate | Predicate: 95-100% | Min-Max (Mean): 90.33 - 100.0 (99.1)% |
| Amplitude Response | Not explicitly stated as "acceptance criteria," but comparison with predicate | Predicate: 90-104% | Min-Max (Mean): 92 - 111 (101)% |
| Ringing | Not explicitly stated as "acceptance criteria," but comparison with predicate | Predicate: 76 cm. |
- Data Provenance: Not explicitly stated regarding country of origin for clinical data. The studies are described as "pre-clinical" and "clinical," with no indication of being retrospective. "Clinical testing was performed to support safety and effectiveness" generally implies prospective data collection for regulatory purposes.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: For the Respiration Rate study, the reference standard was "Clinician-scored EtCO2 capnogram." This implies medical professionals were involved in establishing the ground truth, but their specific qualifications (e.g., types of physicians, years of experience) are not detailed.
4. Adjudication Method for the Test Set
- For Respiration Rate Ground Truth: "Clinician-scored EtCO2 capnogram" implies expert review. However, the exact adjudication method (e.g., 2+1, 3+1, majority vote, independent reads with reconciliation) is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- It is not explicitly stated that a specific MRMC study was conducted to compare human readers with and without AI assistance.
- The device is presented as an "adjunctive tool to other clinical information to support the user," meaning it assists clinicians rather than replacing them. Its effectiveness is shown through its ability to provide accurate EIT data and respiratory rate, which clinicians would then integrate into their assessment. The summary focuses on the device's accuracy relative to reference standards or predicate devices, not on direct human-AI performance comparison studies.
6. Standalone (Algorithm Only) Performance
- Yes, the performance characteristics listed in the tables (e.g., R-squared correlations for EIT-CT, accuracy for RRi against reference standards, SNR, voltage accuracy) represent the standalone performance of the algorithm and the device. The clinical studies compare the device's output itself to established medical standards or other modalities, distinct from how a human user might interpret or use that output.
7. Type of Ground Truth Used
- Pre-clinical (Regional Impedance Distribution): Differential CT changes in aeration (healthy and injured lungs, one- and two-sided intubation) and "established physiological changes" were used as ground truth.
- Clinical (Global Volume Changes): Body plethysmograph traces and Ventilator flow-sensed volumes were used as ground truth.
- Clinical (Regional Impedance Distribution): The Timpel Enlight 2100 predicate comparison was used for ground truth.
- Clinical (Respiration Rate): Clinician-scored EtCO2 capnogram was used as ground truth.
8. Sample Size for the Training Set
- The information provided is a 510(k) summary, which typically focuses on validation. The sample size for the training set is not provided in this document. Training data details are usually proprietary and not disclosed in 510(k) summaries unless directly relevant to the regulatory pathway or substantial equivalence claim.
9. How Ground Truth for the Training Set Was Established
- The document does not specify how ground truth was established for the training set. Similar to the training set size, details about the training data and its ground truth establishment are generally considered proprietary and are not typically included in a public 510(k) summary. The summary focuses on the independent test data performance.
§ 868.1505 Ventilatory electrical impedance tomograph.
(a)
Identification. A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient's thorax.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Characterization of device parameters, including signal-to-noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude response, position error, and ringing;
(ii) Real time evaluation of local impedance variation;
(iii) Plethysmogram accuracy testing; and
(iv) Use life testing of reusable components.
(3) Performance data must validate reprocessing instructions for any reusable components of the device.
(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include the following:
(i) Guidance for interpretation of the images generated;
(ii) A warning that the device should be removed before use of a defibrillator, or defibrillator interaction information based on defibrillator performance testing with the device;
(iii) A use life for any reusable components; and
(iv) Instructions for reprocessing any reusable components.