(201 days)
The Empatica Health Monitoring Platform is a wearable device and cloud-based software platform intended to be used by trained healthcare professionals or researchers to remotely monitor physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments.
The device supports continuous data collection for monitoring the following physiological parameters:
- · Peripheral skin temperature,
- · Electrodermal activity,
- · Blood Oxygen Saturation under no motion conditions,
- · 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 of motion or low perfusion.
The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring temperature at the wrist is clinically indicated.
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 platform is intended to continuously monitor adult patient physiological parameters in homehealthcare environment. It is designed for monitoring patients by trained healthcare professionals or researchers. It is intended to continuously monitor blood oxygen saturation (SpO2), 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.
This document describes the Empatica Health Monitoring Platform, a wearable device and cloud-based software, and its validation for FDA clearance. The primary focus of the performance data in this document is on the Blood Oxygen Saturation (SpO2) monitoring feature.
Here's a breakdown of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides specific performance criteria for several physiological parameters. For the SpO2 feature, a key acceptance criterion is its accuracy, which is compared to the predicate devices and relevant standards.
| Feature / Parameter | Acceptance Criterion (Standard/Predicate) | Reported Device Performance (Empatica Health Monitoring Platform) |
|---|---|---|
| SpO2 Accuracy | - ISO 80601-2-61 compliance |
- FDA Guidance for Pulse Oximeters (2013) compliance
- Predicate Loop System: 3% Arms
- Predicate Current Wearable: ± 2 Digits | 2.6% Arms (across 70-100% SpO2 range) |
| SpO2 Range | 70-100% (Matches predicates) | 70-100% |
| SpO2 Resolution | 1% (Matches predicates) | 1% |
| Temperature Accuracy | ± 0.1°C within 30.0°C - 45.0°C range (Matches predicate Current Wearable, which has ± 0.1°C) | ± 0.1°C within 30.0°C - 45.0°C range |
| Temperature Range | 0°C to 50°C (Matches predicate Current Wearable) | 0°C to 50°C |
| Temperature Resolution | 0.1°C (Matches predicate Current Wearable) | 0.1°C |
| EDA Range | 0.01 µS – 100 µS (Matches predicate Empatica E4) | 0.01 µS – 100 µS |
| EDA Resolution | Predicate Empatica E4: 1 digit ~ 900 pS | 1 digit ~ 55 pS |
| Accelerometer Type | Microelectromechanical system (MEMS)-based integrated circuit (Matches predicate ActiGraph CentrePoint Insight Watch) | Microelectromechanical system (MEMS)-based integrated circuit |
| Accelerometer Sampling Rate | Predicate ActiGraph CentrePoint Insight Watch: Digital method, 32 Hz - 256 Hz | Digital method, 26 Hz - 208 Hz |
| Accelerometer Dynamic Range | Predicate ActiGraph CentrePoint Insight Watch: ± 8 g | ± 16 g |
| Accelerometer Sensitivity | Predicate ActiGraph CentrePoint Insight Watch: 2.4 milli-g per Least Significant Bit | 0.488 milli-g per Least Significant Bit |
Note on "Analysis of differences" for EDA and Accelerometer: For EDA Resolution, Accelerometer Sampling Rate, Dynamic Range, and Sensitivity, the document explicitly states that the differences "shall not raise new concerns of device safety or effectiveness," implying that the reported performance, while numerically different, is still considered acceptable.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for SpO2 Accuracy Test Set: 13 healthy adult subjects.
- Data Provenance: The document does not explicitly state the country of origin but implies it was conducted by Empatica S.r.l., which is based in Milan, Italy. The study was a prospective clinical investigation, comparing the device to a gold standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The ground truth for the SpO2 accuracy test was established using arterial blood gas analysis, which is a direct and objective physiological measurement and is considered the "gold standard." This method does not typically involve human experts for interpreting the ground truth itself, but rather trained medical professionals for collecting the samples and laboratory personnel for performing the analysis. The document does not specify the number or qualifications of these personnel.
4. Adjudication Method for the Test Set
- Not applicable for the SpO2 accuracy study, as the ground truth was established by direct physiological measurement (arterial blood gas analysis), not expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The study described is a direct comparison of the device's SpO2 measurements against a clinical gold standard (arterial blood gas analysis), focusing on the device's standalone accuracy rather than human-in-the-loop performance or improvement with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance study was done for SpO2 accuracy. The clinical study directly evaluated the performance of the Empatica Health Monitoring Platform (device and its algorithms) in measuring blood oxygen saturation against the ground truth, without an explicit human reader component. The device's output was compared to arterial blood gas analysis.
7. The Type of Ground Truth Used
- Clinical Gold Standard / Outcomes Data (Physiological Measurement): For SpO2 accuracy, the ground truth was established through arterial blood gas analysis.
8. The Sample Size for the Training Set
- The document does not provide information regarding the sample size of the training set for the device's algorithms. The clinical study described focuses on the validation of the device's performance, not its development or training data.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for any potential training set was established. The clinical study details focus solely on the method for validating the device's performance against a gold standard.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).