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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.

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Airmod, when used in conjunction with Accursound Electronic Stethoscope AS-101, is a software as medical device intended to be used for the continuous, non-invasive monitoring of respiratory rate (RR) in adult patients who are subjected to procedural sedation and/or anesthesia.

Airmod is intended for use by healthcare professionals in hospitals and healthcare facilities who are legally credentialed to perform procedural sedation and/or anesthesia.

Airmod is intended for Android-based devices only.

Airmod 114 is an Android-based software application designed to aid healthcare professionals by monitoring a sedated and/or anesthetized patient's breathing in real time. The device has an AIbased algorithm that can detect inhalation acoustics and provides respiratory rates based on the analysis of the acoustic signals of breathing sounds collected by AccurSound Electronic Stethoscope AS-101. Airmodid for the continuous monitoring of respiratory rate (RR) in adults who are subjected to procedural sedation. Airmod™ is designed for use in hospitals and healthcare facilities performing procedural sedation/anesthesia. The device is not intended for patients who are not anesthetized/sedated.

Here's a breakdown of the acceptance criteria and study details for the Airmod device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

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The RespiraSense is indicated for continuous, non-invasive, and real-time monitoring of respiratory rate. RespiraSense is indicated for patients 18 years and older in hospital-type facilities and while patients are mobile (e.g., walking). RespiraSense is not intended to be an apnoea monitor.

The RespiraSense (RS) monitors respiratory rate by directly measuring displacements of the chest and abdomen that occur during breathing which are analogous of respiratory rate. This is measured using piezoelectric film elements that output a varying voltage when displaced. The RS device is a non-invasive, wireless, respiratory rate (RR) monitor that is worn on the body of the patient. It is internally-powered, and enables continuous RR monitoring from a single application for up to four days. It is designed to enhance the ability of medical staff to reliably measure respiratory rate remotely. The RS Device is comprised of the RespiraSense Lobe (hereafter the Lobe), the reusable component that houses the RS Device's electronics, a single use adhesive RespiraSense Sensor (hereafter the Sensor) and Cradle. The Lobe and Sensor connect via a secured flat cable and are mechanically fastened together using a plastic Cradle. The Lobe and Sensor are placed on the left-hand side of a patient's torso. The Lobe transmits wirelessly via Bluetooth to an iPad running PMDs RS App for display, control and alert functionality. The RS App allows for Configuring the Lobe, Displaying respiration rate, Display SpO2 and Pulse rate from a connected Nonin device (optional), Configuring alert limits. The RS application can also connect to and display information from multiple Lobes simultaneously. The Lobe is rechargeable. It is designed to be charged using the supplied Charging Station. Charging must be done outside of the immediate patient environment. Charging cannot occur while the device is in operation. Up to six Lobes can be charged at one time. The Sensor is the only patient-contacting device and is secured to the patient with medical grade adhesive.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the RespiraSense device:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: A total of 56 subjects were evaluated.
• Data Provenance: The study was a multi-site comparative clinical testing in the intended population and environment. This suggests the data was collected prospectively for this specific clinical trial. The document does not specify the country of origin, but given it's an FDA submission, it's likely the clinical sites were in the US or followed international standards acceptable to the FDA.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• The document states, "A total of 56 subjects were evaluated by manual counting and / or comparison to a FDA cleared end-tidal CO2 monitor with the observer blinded to the EtCO2 monitor."
• The "manual counting" suggests human observers, but the exact number of experts or their qualifications (e.g., specific clinical experience) are not explicitly stated in this summary.

3. Adjudication Method for the Test Set:

• The document mentions "manual counting and / or comparison to a FDA cleared end-tidal CO2 monitor with the observer blinded to the EtCO2 monitor." This implies a comparison to a referent standard.
• The summary does not detail an explicit adjudication method (like 2+1 or 3+1 consensus) for the manual counting or for resolving discrepancies between manual counts and the EtCO2 monitor, if any. The primary ground truth appears to be the EtCO2 monitor.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance:

• This device, RespiraSense, is a breathing frequency monitor and not an AI-assisted diagnostic imaging device (like those often requiring MRMC studies).
• The study described is a comparative clinical study evaluating the accuracy of the device against a gold standard, not a study assessing the impact of AI on human reader performance. Therefore, an MRMC comparative effectiveness study was not performed in this context, and there's no mention of human reader improvement with AI assistance.

5. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

• The entire clinical study for the RespiraSense device focuses on its standalone performance in measuring respiratory rate. It operates as a continuous, non-invasive monitor, directly providing a measurement. Humans use the device, but its core function (measuring RR) is algorithmic.
• So, the clinical test effectively assesses the standalone performance of the device's algorithm in measuring respiratory rate.

6. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• The primary ground truth used was a "gold standard EtCO2" (End-Tidal Carbon Dioxide) monitor which is an FDA-cleared device for measuring respiratory rate.
• Additionally, manual counting was also performed, serving as a secondary or confirmatory ground truth measure.

7. The Sample Size for the Training Set:

• The document does not specify a separate training set size. This 510(k) summary focuses on the clinical performance of the completed device. For a medical device utilizing an algorithm, training data would have been used during development, but its size is not typically disclosed in the 510(k) summary (which focuses on the final validation/test data).

8. How the Ground Truth for the Training Set was Established:

• As the training set details are not provided, information on how its ground truth was established is not available in this document. It is generally presumed that during the development phase, manufacturers would use similar robust methods (e.g., comparison to calibrated instruments or expert observations) to establish ground truth for their training data.

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The MouthLab Vital Signs Monitoring System is a hand-held, wireless device intended to record, transfer, store and display single lead electrocardiography (ECG), heart rate variability (HRV), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), respiration pattern (RP), oral temperature (TEMP) and basic lung function measurements: peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1).

This system is for spot checking and does not have continuous monitoring capability or any alarm features. The device comes in contact with the user for approximately 60 seconds at each use and the captured medical parameters shall be displayed on a mobile application.

It is intended for use by adults in the home environment and in healthcare facilities. This system makes no specific diagnosis. Respiration rate is not intended for adults with underlying or suspected medical conditions. The device is for single user use.

It is intended for use with users who are well perfused and during no motion condition. Users with implanted pacemakers and/or implanted cardioverter-defibrillators (ICDs) are not recommended to use the device.

The MouthLab Vital Signs Monitoring System is a non-invasive, battery-powered, handheld, wireless, personalized single-user, vital sign measuring apparatus. The device is intended to intermittently monitor the user vitals through the use of an integrated SpO2 sensor, ECG electrodes, microphones and thermistor, which measures the users' functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), oral temperature (TEMP), ECG, heart rate (HR) and heart rate variability (HRV). The users' respiration rate (RR) measurements, respiration pattern (RP) and the basic lung functions (FEV1 and PEF) measurements are obtained are obtained through the acoustic measurement of air turbulence. The vital signs data are transferred to the Aidar Cloud™ Application via a cellular network for processing and storage. This processed data is then displayed on the Aidar Care™ Mobile Application.

The provided document, a 510(k) Summary for the MouthLab Vital Signs Monitoring System (K201635), outlines the device's acceptance criteria and the studies conducted to demonstrate its performance. The device measures multiple physiological parameters, and therefore, different studies were conducted for each.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• SpO2 Measurements: "a controlled desaturation study with adults." The specific sample size is not provided. The data provenance is implied to be prospective clinical testing, likely conducted in a controlled environment as it refers to a "controlled desaturation study." The country of origin is not specified.
• Respiration Rate Measurements: "20 healthy adults." The data provenance is prospective clinical testing. The country of origin is not specified.
• For other parameters (ECG/HR, Pulse Rate, Temperature, PEF/FEV1), bench testing was performed, meaning synthetic data or physical test equipment was used. No human subject sample size is applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Respiration Rate Measurements: Ground truth was established by "a clinician's manually scored capnography (EtCO2) waveforms." The number of clinicians is not specified, and their specific qualifications beyond "clinician" are not detailed.
• SpO2 Measurements: Ground truth was established by "reference co-oximeter analysis of arterial blood gas." This implies laboratory analysis rather than human expert interpretation of raw data. No human experts were explicitly stated to establish this ground truth in the provided text.

4. Adjudication Method for the Test Set:

• For SpO2, and Temperature, the comparison was against a reference standard (co-oximeter, calibrated thermometer) implying direct comparison, not a human adjudication process.
• For Respiration Rate, the comparison was against "a clinician's manually scored capnography waveforms." This suggests a single clinician's scoring was used as ground truth, implying no adjudication method (e.g., 2+1 or 3+1) was employed for establishing this ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was done involving human readers with and without AI assistance (the MouthLab system). The studies described are validation studies comparing the device's measurements to reference standards, not studies on human reader performance improvement.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, the performance data provided describes the standalone performance of the MouthLab Vital Signs Monitoring System in measuring various physiological parameters. The clinical and bench tests evaluate the device's ability to accurately capture and report these values.

7. The type of ground truth used:

• ECG and Heart Rate: Bench testing compliant with IEC 60601-2-27:2012. (Simulated physiological signals)
• Pulse Rate: Bench testing compliant with ISO 80601-2-61:2017. (Simulated physiological signals)
• Temperature: Bench agreement study as per ISO 80601-2-56:2017. (Reference temperature measurements)
• Peak Flow Measurements (FEV1 and PEF): Bench testing according to the ATS Standardization of Spirometry, 2005 Update. (Reference flow/volume measurements)
• SpO2 Measurements: Reference co-oximeter analysis of arterial blood gas. (Objective clinical reference standard)
• Respiration Rate Measurements: Clinician's manually scored capnography (EtCO2) waveforms. (Expert interpretation of surrogate physiological data)

8. The sample size for the training set:

• The document does not explicitly mention a training set sample size. The performance data section focuses on "bench testing" and "clinical testing" for validation, not on the training of machine learning models. If the device uses algorithms trained on data, that information is not detailed in this summary.

9. How the ground truth for the training set was established:

• As the document does not mention a training set, the method for establishing its ground truth is not provided.

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The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is indicated for continuous, noninvasive monitoring of respiratory rate (RRa®). The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is intended for use with infant and neonatal patients, in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The rainbow Acoustic Monitoring® sensors are not indicated for Apnea monitoring.

The subject device, the Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo, is a noninvasive, disposable, single-use device comprising a piezoelectric sensor element and an adhesive strip that is attached to the patient's chest for the purpose of noninvasive respiration/respiratory rate monitoring in infant and neonatal patients (

Here's a breakdown of the acceptance criteria and study details for the Masimo Acoustic Respiration Sensors, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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