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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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