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The Circadia C200 System is intended for the measurement of respiratory rate and heart rate, including spot measurement.
The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities.
The system is not indicated for active patient monitoring, and does not provide alarms for timely response in acute lifethreatening situations. The system is not intended to monitor heart rate in patients with arrhythmias.
The system is intended to be used by healthcare professionals (HCPs) and data are intended by HCPs to inform patient care.
The system also monitors patient motion, and patient presence or absence near the device (exits).

The Circadia C200 System is a contactless system that uses radar to monitor respiratory rate (RR), heart rate (HR), motion, and presence of a patient in its detection range. The System is designed to monitor a patient automatically, without the need for the patient to wear or do anything, or for a healthcare professional (HCP) to interact with the device. The System is thus suitable for long-term and unsupervised monitoring.
The System may also be used to obtain on-demand spot measurements of heart rate and respiratory rate. This allows HCPs to control the frequency and timing of these measurements using the C200 System.
The System consists of the Circadia Contactless Cardiorespiratory Monitor (the "Monitor"), the Circadia Cloud Service (the "Cloud Service"), and the Circadia Pro App (the "App").
The Monitor may be installed next to a patient's bedside. It uses a radar-based motion sensor to detect micromotions caused by ventilation and heartbeat, to measure a patient's RR and HR while the patient is in its detection range at rest. Data is processed continuously on the Monitor, and streamed to the Cloud Service over a Wi-Fi network.
The Cloud Service offers a set of Application Programming Interfaces (APIs) that allows the Monitor to connect to the server and send data over a secure channel. In addition, it allows for patient data to be retrieved from the App.
The App allows a healthcare professional to retrospectively review RR and HR data from multiple connected Monitors. Motion and presence/exit data are available in real time. The App operates from an Android tablet (not supplied, not included in the System). The App includes a functionality to notify a user if no HR has been obtained within the most recent 8 hours.

Here's an analysis of the acceptance criteria and the studies that demonstrate the Circadia C200 System meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on Heart Rate (HR) and Respiratory Rate (RR) monitoring performance. The specific acceptance criteria are stated for HR. For RR, it states equivalence to a reference device.

Note: For Respiratory Rate (RR), the document states that clinical testing demonstrated "RR monitoring performance of the subject device was equivalent to the reference device (Circadia C100 System, K200445)". The specific numerical acceptance criteria for RR are not explicitly detailed in this summary for the subject device, but rather implied by equivalence to the C100.

2. Sample Sizes and Data Provenance for Test Set:

• Heart Rate (HR) Studies:

  • Study 1: N = 49 patients
  • Study 2: N = 41 patients
  • Total: N = 90 patients across both studies.
  • Data Provenance: The document does not explicitly state the country of origin. It describes the subjects as being from "clinical populations" and use cases "representative of the subject device indications for use," which are "clinical settings, such as skilled nursing and long-term care facilities." This suggests prospective clinical data collection.

• Respiratory Rate (RR) Study:

  • The sample size for the RR study is not explicitly stated in the summary, but it refers to "clinical testing" using the Circadia C100 System (reference device).

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the "number of experts used to establish the ground truth" for the test set or their qualifications.

4. Adjudication Method for the Test Set:

The adjudication method is not explicitly stated in the provided text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not reported in this summary. The studies described are focused on the standalone performance of the device against a gold standard, not on how human readers' performance improves with or without AI assistance from this device.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance study was done. The clinical testing described for both Heart Rate and Respiratory Rate directly evaluates the performance of the Circadia C200 System's algorithm against a "gold standard reference HR" and a "reference device" for RR measurement.

7. Type of Ground Truth Used:

• Heart Rate (HR): The ground truth was established using a "gold standard reference HR (obtained using reference device K182030)." This implies a validated medical device known for accurate HR measurement.
• Respiratory Rate (RR): The ground truth was established by comparing the subject device's performance to the "Circadia C100 System (reference device, K200445)," which has identical hardware and RR monitoring functionality. This suggests the C100 itself served as the ground truth reference for RR measurement in its own clinical validation.

8. Sample Size for the Training Set:

The document does not provide any information about the sample size used for the training set of the device's algorithms. The summary focuses solely on pre-market clinical validation studies.

9. How Ground Truth for Training Set Was Established:

The document does not provide any information on how the ground truth for the training set was established. This information is typically not included in the 510(k) summary unless the device relies heavily on historical data for training in a way that directly impacts the clinical validation strategy.

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