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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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The Circadia C100 System is indicated for both contactless spot checking and continuous measurement of respiratory rate data as part of a vital signs assessment. The system records, transmits, and displays respiratory rate from multiple connected devices for retrospective analysis only. The system is intended to be used under the care of clinicians and medically qualified personnel.

The system is indicated for use in adult patients during no-motion conditions, for patients in health care facilities. It is available for sale only upon the order of a physician or licensed health care provider.

The Circadia C100 System is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not intended to monitor vital signs. This system is not an apnea monitor.

The Circadia C100 System consists of three components:

• "The Monitor" - Circadia Contactless Breathing Monitor: The Monitor is a contact-less breathing monitor placed at a bedside table. The Monitor records respiratory rate of adult patients in hospitals and clinical settings (e.g. post-acute care settings such as General Care Floors (GCF), Inpatient Rehabilitation Facilities (IRF), and Skilled Nursing Facilities (SNF)). The Monitor utilizes a UWB-based (Ultra-Wideband based) motion sensor to detect the movement of the abdomen and the chest to derive respiratory data.
• "The App" - Circadia Pro Android App: The App allows Technical Support Staff to setup and configure monitors and allows Clinical Staff to review data collected by the monitors. The App is operated from the central "hub" of a ward or nursing station to monitor data collected by multiple monitors for retrospective analysis only, not for active patient monitoring. The App operates from an Android tablet and uses a USB-C connection for initial configuration. The App is designed to communicate with The Monitor and allow it to connect to a Wi-Fi network and subsequently, The Cloud Service.
• "The Cloud Service" - Circadia Cloud Service: The Cloud Service offers a set of APIs that allows the monitor to connect to server, send respiratory data over a secure channel, and allows the monitor to track Clinical Staff's personal data and the patient's respiratory data.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) summary for the Circadia C100 System:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Circadia C100 System, specifically for its respiratory rate (RR) accuracy, are derived from the clinical testing results that demonstrated its substantial equivalence to a predicate device.

Note: The document states that the performance met 'acceptance' but does not explicitly list the target acceptance criteria in the format of a table with specific thresholds. Instead, it presents the results of a comparison study intended to demonstrate substantial equivalence to a predicate device and a gold standard. The +/- 2 breaths/min accuracy and the -3.2 to +0.7 breaths/min 95% Limits of Agreements (LoA) are the results that satisfied the FDA's requirements for substantial equivalence for this device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • Comparison to end-tidal CO2 capnography (gold standard): 12 patients
  • Comparison to chest and abdomen worn band (predicate/reference device): 26 patients
  • Total unique patients: While not explicitly stated, it seems these are two distinct sub-studies, leading to a total of 38 unique subjects (12 + 26).
• Data Provenance: Not specified (e.g., country of origin, specific healthcare facilities). The document mentions "patients in health care facilities" (page 2) and "adult patients in hospitals and clinical settings" (page 4), but no specific location.
• Retrospective or Prospective: Not explicitly stated. However, clinical testing for 510(k) submissions typically involves prospective data collection to evaluate real-time performance. Given the details about monitoring various conditions and subject postures, it suggests prospective data collection.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth for the capnography data is implicitly established by the device producing that data ("manually scored end-tidal CO2 capnography data"). For the chest/abdomen worn band, it serves as a comparative reference rather than a direct ground truth source that required expert interpretation for its output.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. The ground truth was established by readings from established medical devices (end-tidal CO2 capnography and a chest/abdomen worn band), not through expert consensus requiring adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• The study design focused on comparing the device's measurements against established methods (gold standard capnography and a predicate band), rather than evaluating how AI (or the device's) assistance improves human reader performance. This device is a measurement device, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance evaluation was done. The "accuracy of Respiration rate" and "95% limits of agreements" reported are for the Circadia C100 system itself, directly measuring the respiratory rate. The clinical testing specifically describes comparing the device's performance against the gold standard and the predicate device.

7. Type of Ground Truth Used

• Clinical/Physiological Reference Data: The primary ground truth was "manually scored end-tidal CO2 capnography data" (from devices cleared in K040875 and K120888), which is considered a gold standard for respiratory rate measurement.
• Comparative Reference: Performance was also compared against data from a "chest and abdomen worn band" (device cleared in K122516), which serves as a predicate/reference device rather than a ground truth in itself.

8. Sample Size for the Training Set

• Not specified. This document is a 510(k) summary for a medical device that uses UWB-based motion sensing, not a machine learning or AI algorithm in the contemporary sense that typically relies on large training datasets for feature learning. While the device certainly processes signals, the document doesn't indicate a machine learning training phase with a distinct training set. The device likely uses signal processing algorithms tuned during development rather than trained on a large dataset in the way a deep learning model would be.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as a distinct training set with established ground truth as for a machine learning model is not mentioned or implied by the description of the device's technology. The device utilizes physical principles (UWB radar to detect chest/abdomen movement) and signal processing, not a data-driven "training" process in the AI/ML context.

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