(268 days)
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.
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SpO2 QI Algorithm - Bench Testing | Sensitivity, Specificity, and False Discovery Rate of the modified SpO2 QI algorithm in discriminating low-quality and high-quality data are non-inferior to the SpO2 QI in the FDA-cleared SpO2 algorithm. | Implied to have met criteria, as the device received 510(k) clearance. Full performance metrics are not explicitly stated in this document but are described as being non-inferior. |
| SpO2 Algorithm - Clinical Testing (Arms Error) | The Arms error of the modified SpO2 algorithm is lower or equivalent to the FDA-cleared SpO2 algorithm. | Implied to have met criteria, as the device received 510(k) clearance. Full performance metrics are not explicitly stated in this document but are described as being lower or equivalent. |
| SpO2 QI Algorithm - Clinical Testing (Percent Agreement) | The percent agreement between the modified SpO2 QI outputs and the FDA-cleared SpO2 QI outputs must be equal to or higher than 90%. | Implied to have met criteria, as the device received 510(k) clearance. Full performance metrics are not explicitly stated in this document but are described as being equal to or higher than 90%. |
| Software Verification Tests | All software verification tests linked to requirements and specifications must pass. | Implied to have met criteria, as the device received 510(k) clearance. |
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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).