(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% ( |
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).