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510(k) Data Aggregation
(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.
Ask a specific question about this device
(92 days)
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic monitoring of patients aged 14 years old and above in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated.
The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters:
- · Pulse rate
- · Oxygen saturation
- · Temperature
- Movement
The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring of:
- · Respiration rate
- · Non-invasive blood pressure
- · Lung function & spirometry
- · Weight
The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.
The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
The Current Wearable System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by 14 years old and above patients, a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs.
The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.
The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.
I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for the Current Health System, focusing on an age range extension. While it mentions the device's intended use and compares it to a predicate device, it explicitly states that "no animal or clinical performance data is included" (Page 11) and that "The performance of the modification is identical to the predicate and previously cleared device in terms of technical specification and safety." (Page 11).
Therefore, there is no study described that proves the device meets specific acceptance criteria through performance data, sample sizes, expert involvement, or ground truth establishment. The submission relies on the existing clearance of the predicate device for its performance claims.
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