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The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.

The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:

• Pulse Rate,

• · Blood Oxygen Saturation under no-motion conditions,
• · Respiratory Rate under no motion conditions,
• · Peripheral Skin Temperature,
• · Electrodermal Activity,
• · Activity associated with movement during sleep

The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.

The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.

The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.

The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy. and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.

The Empatica Health Monitoring Platform is a wearable device and software platform composed by:

• A wearable medical device called EmbracePlus,
• A mobile application running on smartphones called "Care App", ●
• A cloud-based software platform named "Care Portal". ●

The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.

The Empatica Health Monitoring Platform is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters and digital biomarkers by trained healthcare professionals or researchers: Pulse Rate (PR), Respiratory Rate (RR), blood oxygen saturation (SpO-), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.

Here's a summary of the acceptance criteria and the study details for the Empatica Health Monitoring Platform, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Pulse Rate:
  • Study 1: 12 healthy adult subjects.
  • Study 2: 85 healthy adult subjects.
  • Study 3: 49 adult subjects (healthy, PVCs, other comorbidities).
  • Total N = 146 adult subjects.
  • Data Provenance: Not explicitly stated, but clinical studies are generally prospective in nature for regulatory submissions. Country of origin not specified.
• Respiratory Rate:
  • Study 1: 14 healthy adult subjects.
  • Study 2: 46 healthy adult subjects.
  • Study 3: 17 adult subjects with various health conditions.
  • Study 4: 40 adult subjects with various health conditions.
  • Total N = 117 adult subjects.
  • Data Provenance: Not explicitly stated, but clinical studies are generally prospective in nature for regulatory submissions. Country of origin not specified.
• SpO2, Temperature, EDA, Activity/Sleep: For these parameters, the submission relies on previous clearance (K221282), indicating no new clinical test data was provided for this specific submission. The reported performance for these parameters is thus based on the studies supporting K221282. Sample sizes and provenance for those underlying studies are not detailed in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• The document does not mention the use of human experts to establish ground truth for the test sets.
• Instead, for Pulse Rate, the ground truth was established using a reference electrocardiogram (ECG).
• For Respiratory Rate, the ground truth was established using a capnography reference device.

4. Adjudication Method for the Test Set

• Not applicable as the ground truth was established against reference medical devices (ECG, capnography) rather than human expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies described are focused on the standalone performance of the device against reference standards.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, standalone studies were performed. The clinical data presented for Pulse Rate and Respiratory Rate directly evaluate the accuracy of the device's computed values against reference standards, without human intervention in the measurement process. The device itself is described as a "platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring," implying that the data collection and parameter computation are algorithmic, and review is done by humans.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

• Pulse Rate: Reference Electrocardiogram (ECG).
• Respiratory Rate: Reference Capnography device.
• SpO2: Based on the technology description, it would typically be a co-oximeter or a clinically validated pulse oximeter meeting ISO standards. The document notes that no new clinical data for SpO2 was provided, relying on K221282, which would have established ground truth similarly.

8. The Sample Size for the Training Set

• The document does not provide details about the sample size for the training set used for the device's algorithms. It focuses entirely on the clinical validation (test set) data.

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

• The document does not provide details on how the ground truth for the training set was established. This information is typically not included in a 510(k) summary, which focuses on the validation of the final product.

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