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The Makani Science™ Respiration Monitoring System is indicated for continuous, non-invasive, and real-time monitoring of a patient's breathing. It graphically displays respiration versus time and reports the respiratory rate value.

The Makani Science™ Respiration Monitoring System is intended to be used by healthcare professionals in healthcare facilities and dental offices on adult patients aged 22 or older. It is not intended to be used as an apnea monitor.

The Makani Science™ Respiration Monitoring System (Makani Science RMS) is a respiration rate (RR) monitoring system that consists of a pair of identical, battery-powered, wireless, Makani Science Ahe™ Respiration Sensors (Ahe Sensors - piezo-resistive strain sensors) and the Makani Science Ahe™ App (Ahe App), which is deployed and runs on an Apple® iPad®. The two (2) small and lightweight Ahe Sensors are paired to the Ahe App using Bluetooth Low Energy (BLE) 5.0 technology. The Makani Science RMS is intended to be used by trained healthcare providers (HCPs) in the management of their patients. The Ahe Sensors are single-patient use sensors and can be used up to 24 hours of continuous use. The sensors are applied to the patient's intact skin using an adhesive tape built into the sensors and are made to be retained on the skin in nonambulatory use situations, such as supine on a procedure room table or semi-recumbent in a dental chair. One sensor is applied to the patient's thoracic region and the other sensor is applied to the abdomen region. Correct placement of these sensors is important to the effectiveness of the device, and specific guidance is provided to the user in the labeling on where to place the sensors. The Ahe App is a software application, which guides the user through system setup and monitoring using display screens. During use, the iPad is forced into guided access, or "kiosk" mode, which prevents the user from using any other applications during the monitoring session. Once setup is complete and monitoring initiated, the Ahe App displays a graphical rendition and numerical value of the patient's RR. Low and high RR alarm thresholds provide a visual and audible notification if the patient's RR violates the user-determined alarm thresholds. Monitoring continues until the user terminates the monitoring session, at which time the Ahe App can save a report of the monitoring session to an external memory card, if desired by the user. No patient health information (PHI) is retained by the Ahe App after completion of the monitoring session. The Makani Science RMS does not interact with any third-party medical or non-medical devices other than a memory card that is used to store a report of the patient's monitoring session.

The Makani Science™ Respiration Monitoring System is designed for continuous, non-invasive, and real-time monitoring of a patient's breathing, graphically displaying respiration versus time and reporting the respiratory rate value. It is intended for use by healthcare professionals in healthcare facilities and dental offices on adult patients aged 22 or older.

Acceptance Criteria and Reported Device Performance

Although specific numerical acceptance criteria are not explicitly listed in the provided text, the document states that the device was evaluated against performance requirements, applicable standards, and guidance documents. The key performance metric mentioned is Respiratory Rate (RR) Accuracy.

This reported accuracy is directly compared to the predicate device's accuracy (PMD Solutions / RespiraSense, K220111), which also has an RR Accuracy of ± 3 BPM, indicating that the Makani Science™ RMS meets the established performance benchmark for respiration rate accuracy.

Study Proving Device Meets Acceptance Criteria

A clinical performance study was conducted to validate the respiration rate accuracy of the Makani Science™ Respiration Monitoring System.

1. Sample Size and Data Provenance:

   • Test Set Sample Size: 29 human subjects.
   • Data Provenance: The document does not explicitly state the country of origin, but it is clear the data is from human subjects from the "intended use population," implying a clinical setting. The study appears to be prospective, as it involved actively testing subjects with the device.

2. Experts for Ground Truth Establishment:

   • The document does not detail the number or qualifications of experts used to establish the ground truth beyond stating "manually counted end-tidal CO2." It is implied that healthcare professionals or trained personnel performed the manual counting.

3. Adjudication Method:

   • No adjudication method is described. The ground truth was established by "manually counted end-tidal CO2 using an FDA-cleared capnogram," suggesting a direct, objective measurement rather than subjective interpretation requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was mentioned or performed. The study focused on the device's accuracy against a "gold standard" rather than comparing human reader performance with and without AI assistance.

5. Standalone Performance:

   • Yes, standalone (algorithm only) performance was assessed. The accuracy of the Makani Science™ RMS was validated against a gold standard method, specifically "manually counted end-tidal CO2 using an FDA-cleared capnogram." This evaluates the device's ability to accurately measure respiratory rate independently.

6. Type of Ground Truth Used:

   • "Gold standard, manually counted end-tidal CO2 using an FDA-cleared capnogram." This represents a direct, objective physiological measurement.

7. Training Set Sample Size:

   • The document does not specify the sample size for the training set. The clinical study mentioned is for performance validation, not for training the algorithm.

8. Ground Truth Establishment for Training Set:

   • The document does not explicitly describe how the ground truth for the training set was established. However, given the nature of the device (respiration monitoring), it can be inferred that training data would likely involve various respiration patterns with corresponding accurate respiratory rate measurements, potentially derived from similar gold standard methods as used for the test set.

Additional Performance Testing Details:

The clinical testing also included:

• RR validation in all four available postures (supine, right side, left side, and reclined).
• Sub-group analysis to demonstrate maintained RR accuracy regardless of patient demographics (sex, BMI (healthy, overweight, and obese), Fitzpatrick skin type).
• Accuracy maintained in the presence of comorbidities.
• Accuracy maintained in the presence of artifacts (e.g., coughing).
• Accuracy maintained following positional change (e.g., supine → reclined position).
• Successful demonstration that RR accuracy was maintained over 24 hours of continuous use in bench testing.

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