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510(k) Data Aggregation
(270 days)
The RTM Vital Signs RTMsense is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and general wards, to monitor breathing in adult (at least 22 years old) patients.
RTMsense is a non-invasive system that graphically displays respiratory function against time and reports respiratory rate.
RTMsense measurements are used as an adjunct to other clinical information sources.
The RTMsense Respiratory Monitoring System is a single use wearable device consisting of a wearable trachea sound sensor (TSS) and software that continuously measures a patient's respiratory rate by analyzing the sounds of air flow within the proximal trachea during inhalation and exhalation. The acoustic signal is transmitted wirelessly to a Lenovo Tablet, and the respiratory measurement values are displayed on the tablet after analysis of the acoustic data by a proprietary software algorithm.
The RTMsense software application has three parts: firmware on the TSS, a web-based application on the Lenovo tablet, and a cloud-based proprietary software algorithm. The TSS securely transmits acoustic data wirelessly to the local, Bluetooth low energy enabled Lenovo tablet. The tablet uses a web-based application to securely transmit the acoustic data to the cloud for analysis in RTM's proprietary cloud-based algorithm. The web application retrieves the processed data from the algorithm to display respiratory rate on the tablet.
The device will be used by healthcare professionals in healthcare facilities such as post-operative care or general wards. The RTMsense respiratory measurements are used as an adjunct to other clinical information sources.
The TSS is held in place by a flexible wearable carrier adhered to the patient's proximal trachea with commercially available medical grade adhesive. The TSS contains the audio sensor, onboard processing, wireless communications technology, and Lithium-ion coin cell rechargeable battery. A custom charger is provided to charge the battery.
The provided FDA 510(k) clearance letter and summary for the RTM Sense (A-0001) device details several aspects of its performance and validation. However, it does not explicitly provide a table of acceptance criteria for specific metrics, instead focusing on overall "passing" of predefined performance criteria. The information regarding ground truth establishment for the training set, number and qualifications of experts, and adjudication methods is also limited.
Based on the provided text, here's an attempt to reconstruct the information:
Overview of RTM Sense (A-0001) Performance Study
The RTM Sense (A-0001) is a non-invasive respiratory monitoring system that continuously measures a patient's respiratory rate by analyzing tracheal sounds. The device, intended for use by healthcare professionals in healthcare facilities, underwent non-clinical and clinical performance testing to demonstrate its safety and effectiveness and establish substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance
While explicit acceptance criteria are not presented in a table format within the document, the "Clinical Performance Testing" section describes primary endpoints that serve as de facto acceptance criteria. The results indicate that the device met these criteria.
| Metric (Implied Acceptance Criteria) | RTMsense Performance (Study #1) | RTMsense Performance (Study #2) |
|---|---|---|
| Accuracy (Mean Absolute Error) | 0.58 b/min ($\le$ 1 BPM) | 0.38 b/min ($\le$ 1 BPM) |
| Mean Accuracy Error (%) | 2.30% (< 5%) | 2.94% (< 5%) |
| Intraclass Correlation Coefficient | 0.989 and 0.994 (p<0.0001) | Not reported for Study #2, but "No statistically significant difference in RR between RTM and Reference p=0.856" implies high correlation. |
| Statistical Difference in RR | Not explicitly stated as acceptance, but p<0.0001 and p=0.856 respectively indicate no significant difference from gold standard for both studies. | No statistically significant difference (p=0.856) |
Note: The acceptance criteria are inferred from the "Primary endpoints assessed were accuracy ≤ 1 BPM and mean accuracy error < 5%."
2. Sample Size and Data Provenance for Test Set
- Total Sample Size: Combined, the studies included 44 subjects and over 150 breath samples.
- Study #1: 31 subjects and 124 breath samples.
- Study #2: 13 subjects and 65 breath samples.
- Data Provenance: The document does not explicitly state the country of origin. It indicates that the studies were prospective comparative studies.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set. Ground truth was established by "Manually scored End-Tidal CO2 breath counts from the capnometer." This suggests a direct technical measurement rather than expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or reported. The study design focused on comparing the device's measurements directly against a gold standard (capnometer), not on how AI assistance improves human reader performance. Therefore, no effect size for human reader improvement with AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was conducted. The "Clinical Performance Testing" directly evaluates the RTMsense device's (which includes its proprietary software algorithm) accuracy against a gold standard respiratory measurement (Hamilton C-1 Ventilator with integrated Capnostat 5 capnometer). The reported results (accuracy, bias, % error) are based on the algorithm's performance in calculating respiratory rate from acoustic signals.
7. Type of Ground Truth Used
The ground truth used for the clinical performance testing was technical measurement/outcomes data. Specifically, "Manually scored End-Tidal CO2 breath counts from the capnometer" from a Hamilton C-1 Ventilator with integrated Capnostat 5 capnometer were used as the gold standard reference.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. It only describes the clinical validation (test set) data.
9. How the Ground Truth for the Training Set was Established
The document does not describe how the ground truth for the training set was established. It only refers to "RTM's proprietary cloud-based algorithm" that processes acoustic data and "Software Verification / Validation Testing" which states "Integration and algorithm testing was conducted to verify the software meets its requirements and accurately reports respiration rate." This implies internal validation of the algorithm, but details about the training data and its ground truth establishment are absent.
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