Search Results

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 WiFi 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 (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.

The provided FDA 510(k) clearance letter and its attachments describe the acceptance criteria and study that proves the Empatica Health Monitoring Platform (EHMP) meets those criteria, specifically concerning a new Predetermined Change Control Plan (PCCP) for the SpO2 quality indicator (QI) algorithm.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are outlined for the proposed modification to the SpO2 Quality Indicator (QI) algorithm. The reported device performance is presented as a statement of equivalence to the predicate device, implying that the acceptance criteria are met, as the 510(k) was cleared.

Note: For the pre-existing functionalities (Pulse Rate, Respiratory Rate, Peripheral Skin Temperature, Electrodermal Activity, Activity and Sleep), the document states that "no changes to the computation... compared with the cleared version" have been introduced, implying their previous acceptance criteria were met and remain valid.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated for the SpO2 algorithm modification. The document only mentions "enhancing the development dataset with new samples" for the ML-based algorithm and clinical testing was "conducted in accordance with ISO 80601-2-61... and ... FDA Guidelines for Pulse Oximeters." These standards typically require a certain number of subjects and data points, but the exact numbers are not provided in this public summary.
• Data Provenance: Not specified in the provided document. It does not mention the country of origin, nor whether the data was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document states the platform is "intended to be used by trained healthcare professionals or researchers," and later discusses "professional users" and "clinical interpretation," implying that the ground truth for clinical studies would likely involve such experts, but their specific roles, numbers, and qualifications for establishing ground truth are not detailed.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth for the test set is not explicitly mentioned in the provided document.

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

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being conducted, nor any effect size regarding human readers improving with AI vs. without AI assistance. The device is for "retrospective remote monitoring" by healthcare professionals, implying an AI-driven data collection/analysis with human review, but not necessarily human-AI collaboration in real-time diagnostic interpretation that an MRMC study would evaluate.

6. Standalone (Algorithm Only) Performance

The acceptance criteria for the SpO2 QI algorithm include "Bench testing conducted using a functional tester to simulate a range of representative signal quality issues." This falls under standalone performance, as it tests the algorithm's ability to discriminate data quality without direct human input. Clinical testing also evaluates the algorithm's accuracy (Arms error) in comparison to an established standard, which is also a standalone performance measure.

7. Type of Ground Truth Used

• For the SpO2 QI ML algorithm: The ground truth for low-quality and high-quality data discrimination seems to be an internal standard/reference based on the "FDA-cleared SpO2 algorithm" and potentially expert labeling of data quality during the "enhancing the development dataset."
• For the SpO2 Accuracy (Arms Error): The ground truth for SpO2 values would be established in accordance with ISO 80601-2-61, which typically involves comparing the device's readings against a laboratory co-oximeter or a reference pulse oximeter for arterial oxygen saturation.

8. Sample Size for the Training Set

The document mentions "enhancing the development dataset with new samples" for the ML-based algorithm but does not specify the sample size for the training set.

9. How Ground Truth for Training Set was Established

The ground truth for training the ML-based SpO2 QI algorithm was established by "enhancing the development dataset with new samples." It also mentions performing "feature extraction and engineering on window lengths spanning a 10-30-second range." While it doesn't explicitly state the methodology, given the context of a "binary output" (high/low quality), it implies a labeling process, likely by human experts or based on predefined criteria derived from the previous FDA-cleared algorithm's performance on various data types. For the SpO2 accuracy, the ground truth would typically be established by a reference method consistent with the mentioned ISO standard and FDA guidance.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

• 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.

Ask a specific question about this device