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The RHEA Vital Sign Vigilance System is intended for continuous measurement of respiration rate and heart rate for adults (≤150kg), in an automatic contact-less manner, in hospital or clinic setting condition.

The RHEA Vital Sign Vigilance System is designed for continuous and contact-less measurement of a patient's heart rate and respiratory rate. The system can also notify the user when the patient exits the bed. The system incorporates three main components: Bedside unit, Sensor unit (including fiber cable), and Data Export Software. The sensor detects movement vibrations from the patient's body and converts them into an optical signal. The bedside unit receives the optical signal from the sensor, calculates the heart rate and respiratory rate, displays the vital signs on the screen in real-time, and records and stores the patient data.

Here's a breakdown of the acceptance criteria and study information for the RHEA Vital Sign Vigilance System, based on the provided text:

Acceptance Criteria and Device Performance

General Performance:

• Parameter Performance Testing: The device's performance (heart rate, respiration rate accuracy, on/off bed notifications) was assessed under variations in heart rate amplitude to respiration rate amplitude, patient position, mattress thickness, mattress materials, and patient weight. The results "demonstrate that the performance of the RHEA device should not be significantly affected by variations in these factors within expected limits and that the device performs in accordance with specifications."
• Denoising Performance Testing: The RHEA device was able to identify potential sources of motion artifact more frequently than the predicate device. The time required for the RHEA device to recover from motion artifacts was within specifications and comparable to the predicate device.
• Clinical Data: The accuracy of the RHEA Vital Sign Vigilance System was confirmed for both heart rate and respiration rate when compared against the reference IntelliVue Patient Monitor. "The RHEA Vital Sign Vigilance System did not degrade toward the extremes of the observed range of heart rates (51 to 115 bpm) or respiratory rates (9 to 32 br/min) and did not vary with the patient diagnosis/hospital location or body weight."

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Clinical Data: The text does not explicitly state the specific sample size for the clinical test set. It mentions the observed range of heart rates (51 to 115 bpm) and respiratory rates (9 to 32 br/min) and discusses variations among different sites, implying a multi-site clinical study.
   • Data provenance: Not explicitly stated, but the mention of "different sites" suggests a prospective, multi-site clinical study. The clinical data section describes the comparison of the RHEA device against a reference device, indicating a prospective clinical study with real patient data. It is not specified if the data is from a single country or multiple.
   • Denoising Performance Testing: Twenty normal volunteers were used. Provenance is not specified (e.g., country of origin, retrospective/prospective). This appears to be a prospective bench study with human subjects.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention the use of experts to establish ground truth.
   • For the clinical study, the ground truth was established by a reference device, the IntelliVue Patient Monitor, rather than expert consensus on images or interpretations.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • "None" for establishing ground truth, as the ground truth was based on a reference device.
   • The document does not describe any adjudication method for interpreting results or resolving discrepancies, as it was a direct comparison to a reference device.

4. 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, an MRMC comparative effectiveness study was not done. This device measures vital signs directly and automatically, not through interpretation by human readers. The clinical study compares the device's measurements to a reference medical device, not to human interpretation or human improvement with AI assistance.

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

   • Yes, a standalone study was done. The clinical data section explicitly states, "The accuracy of the RHEA Vital Sign Vigilance System when compared against the reference IntelliVue Patient Monitor was confirmed for both heart rate and respiration rate." This is a direct comparison of the device's automated measurements (algorithm only) to a gold standard, without human intervention in the measurement process.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the accuracy evaluation, the ground truth was data from a reference medical device: the IntelliVue Patient Monitor.

7. The sample size for the training set:

   • The document describes performance testing and clinical evaluation of the final device. It does not provide information about the training set size used for developing the device's algorithms, as this is typically part of the development phase, not the regulatory submission's performance evaluation section.

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

   • Similar to the training set size, the document does not detail how the ground truth for the training set was established. This information would be part of the device's development and internal validation, which is typically not disclosed in summary K-submissions unless specifically requested by FDA for complex AI/ML devices.

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