Search Results
Found 3 results
510(k) Data Aggregation
(125 days)
LifeSignals, Inc.
The UbiqVue 2A Multiparameter System is a wireless remote patient monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include electrocardiography (2-Channel ECG), heart Rate, SpO2%, respiration rate, pulse Rate, photoplethysmography waveform, skin temperature, body posture, body motion, R-R Interval, heart Rate variability (HRV) and blood Pressure (optional). Data is transmitted wirelessly near real time from UbigVue 2A Wearable Biosensor and 3rd party device (for Blood Pressure only) to remote central server for display, storage, and analysis.
The UbiqVue 2A Multiparameter System is intended for non-critical, adult population.
The UbiqVue 2A Multiparameter System shall include the ability to notify healthcare professionals through alerts when physiological parameters fall outside the set limits, manual trigger by the patient and to display multiple patient's physiological data for remote monitoring at home and with visual alarm for active monitoring at hospitals and out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals.
The UbiqVue™ 2A Multiparameter System is similar to LifeSignals Multiparameter Remote Monitoring Platform that is cleared under K202868 but upgraded with monitoring of additional physiological parameters, minor performance improvements and additional User Interface.
The UbiqVue™ 2A Multiparameter System consists of following components:
-
- UbiqVue™ 2A Wearable Biosensor
-
- UbigVue™ Single Patient Relay
-
- UbiqVue™ Multi-Patient Relay
-
- UbiqVue™ Central Server
-
- UbiqVue™ Active Monitoring Portal
-
- UbiqVue™ Relay Bridge Software (optional)
-
- UbiqVue™ Bluetooth Gateway Software (optional)
-
- Third-party Blood Pressure device (optional)
The UbigVue™ 2A Wearable Biosensor when attached to body acquires two channels of ECG signals, TTI respiration signals (one of the inputs for deriving Respiration Rate), resistance variation of a Thermistor attached to body (used for deriving Skin Temperature) & accelerometer data (input for deriving Respiration Rate & Posture), pre-processes them and wirelessly transmits to a paired Relay device, as cleared under K202868.
Following are additional features proposed in this submission:
- Ambient temperature sensor for Body temperature derivation.
- Acquisition of PPG (Photoplethysmography) signals using the integrated Optical sensor array.
- Derivation of SpO2% and Pulse Rate within the Biosensor, based on PPG signals acquired through the Optical sensor array.
Biosensor uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device, as cleared under K202868. The Biosensor is also additionally integrated with BLE Radio for communication with Single Patient Relay device.
As cleared under K202868, when Relay device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If Relay device is not available or if there is any interruption in the communication between Relay device and Biosensor, data shall be temporarily buffered locally in Biosensor till the wireless connection is re-established.
The UbigVue™ Single Patient Relay Device, a standard Mobile device or custom device that is installed with a UbigVue Single Patient Relay Application software, that receives the physiological data transmitted from any paired Biosensor. It shall transmit the data received from the Biosensor, immediately without any day to Central Server that is configured to receive, after necessary data encryption. The Single Patient Relay Device shall receive data from Biosensor either through WLAN or BLE and transmit it to Central Server using its mobile data network (3G, 4G, LTE, 5G, etc.)
Single Patient Relay Device function is identical to the one cleared under K202868, except it is upgraded to support additional parameters & also improvements in GUI as below:
- To handle additional data packets of Biosensor such as Ambient Temperature, PPG signals. SpO2% and Pulse Rate.
- Interactive GUI that provides feedback to Users about the signal quality of PPG signals to identify the optimal body location for affixing the Biosensor.
- Shall pair with a 3rd party Blood Pressure device using BLE and transfer the data to the Central Server.
- Allows User to enter Oral Temperature reading (for calibration) and/or manual Blood pressure data (optional if no 3td Party device is connected).
The UbiqVue™ Multi-Patient Relay Device (MPR) is an UbiqVue™ Multi-Patient Relay Application Software installed in a standard Linux platform (Physically or in cloud), that has ability to pair & receives data from multiple Biosensors, through wireless access points (WLAN) connected in its network. It shall transmit the received data from Biosensors to Central Server that is configured to receive through internet or private network (VPN), after necessary encryption & authentication. Multi-Patient Relay Device also receives data from multiple third-party Blood Pressure devices worn by the patients & connected to its network (through BLE gateway).
If the Central Server is not available or there is no connectivity, the data shall be temporarily buffered securely in the MPR device itself. There is no GUI component for this software application.
The UbigVue™ Central Server is UbiqVue™ Central Server Application software installed in a compatible Linux Server hardware Platform. The Central Server Application functions are also identical to Secure Server Application in LifeSignals Multi-parameter Remote Monitoring Platform (K202868), other than being upgraded to handle additional parameters. Also, the "Sensor Processing Library", the algorithm that derives various vital parameters is upgraded for performance improvements. The following are additional features:
- Extending the minimum skin temperature measurement capability from 32.0℃ (89.6 °F) to 15.0°C (59.0°F)
- Body Temperature estimation using Skin Temperature, Ambient temperature, Heart Rate (based on clinical condition) and Activity.
- Uses the Oral Temperature entered manually for initial / periodic calibration of derived Body temperature.
- Additional Posture classification & Body motion detection capabilities.
- Improvements in Respiration Rate & Heart Rate derivation algorithm.
- Integration with 3rd Party beat analysis & classification software for deriving Sinus Heart Rate, R-R Interval & Heart Rate Variability.
- The PPG Signal Quality Index (SQI) algorithm module for displaying the SQI on the Active Monitoring dashboard & to access the quality of SpO2 value derived by the Biosensor.
- Support for Early Warning Score (NEWS2) calculation.
Central Server shall have ability to send alert notifications to any configured one or more Users through E-mail, SMS or WhatsApp, for any Clinical, Technical or Manual Alert conditions, as cleared under K202868. However, this alert engine is upgraded to support additional parameters and improved configuration capabilities such as Acknowledgement, priority & condition delay time.
Active Monitoring Portal in UbiqVue™ 2A Multiparameter System is identical to Web UI in LifeSignals Multi-parameter Remote Monitoring Platform cleared under K202868. It is a browser-based User Interface Application that enables Clinical personnel to login to the Central server remotely and access the patient physiological data (Biosensor & derived data) and view/Acknowledge the Alert(s). The Clinical personnel, depending on the roles (normal or supervisory) can access data of multiple patients assigned to them and search them based on the recent alert status. This includes patients that are active (wearing Biosensor) and monitoring procedures completed.
It is in-built with a Monitoring Dashboard that continuously displays physiological parameters, waveforms & alert status of any assigned patients to any authenticated Clinical personnel for (quasi) real time Active Monitoring. It has the option for the User to select multiple patient tile view or Single Patient Zoom View/Hybrid view of any patient based on multiple available filter settings.
Following are the few changes in this 510(k):
- Additional parameters (SpO2%. PR, EWS, SYS, DIA, MAP, PPG, SQI, EWS).
- Visual alarm display for any Clinical, Technical, or manual alert/alarm.
- Hybrid tile view (Zoom View + Tile view) and Group tile view.
- Multi-level User Management, roles & privileges.
Note: Any Third-Party Application / Server may communicate with UbiqVue™ Central Server using a defined set of Application Programming Interface (API) for entering patient information, configuring & generating customized report or any other requirement that does not alter the intended use of the system (e.g., EMR/EHR, HIMS) or to meet the additional intended use claimed by the third-party application. UbigVue™ Active Monitoring Portal shall continue to be used for the claimed Active Monitoring intended use. However, UbiqVue™ Active Monitoring portal may be optional for integration with any other regulatory approved monitoring dashboard or different intended use claims.
Relay Bridge Software in UbiqVue™ 2A Multiparameter System when installed in a standard OpenWrt based routers, shall provide communication between Biosensor(s) & Multi-Patient Relay. Relay Bridge is an alternate for a standard access point and is intended when Multi-Patient Relay Software is hosted in the cloud. Similar to standard access point, the Relay Bridge communicates with multiple Biosensor and transfers the data to the Multi-Patient Relay without buffering the data. Since the Relay bridge transfers the data to the designated Multi-Patient Relay bridge in the cloud, it further encrypts the data for securely transmitting through the internet via ethernet, Wi-Fi or cellular network.
Bluetooth Gateway Software in UbigVue™ 2A Multiparameter System when installed in a standard OpenWrt based BLE gateway or BLE supported routers, shall provide communication between 3rd party BLE devices (e.g. BP device) & Multi-Patient Relay. Bluetooth Gateway communicates with multiple 3rd party devices and transfers the data to the Multi-Patient Relay without buffering.
LifeSignals, Inc. has developed the UbiqVue™ 2A Multiparameter System (UX2550), a wireless remote patient monitoring system. The device collects continuous physiological data including 2-Channel ECG, heart rate, SpO2%, respiration rate, pulse rate, photoplethysmography waveform, skin temperature, body temperature, body posture, body motion, R-R Interval, heart rate variability (HRV), and optionally blood pressure. The system transmits data wirelessly to a remote central server for display, storage, and analysis, and can notify healthcare professionals through alerts. It is intended for non-critical, adult populations in home and healthcare settings.
The following information describes the acceptance criteria and the study conducted to prove the device meets these criteria:
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Heart Rate | Range: 30 – 250 BPM | |
| Accuracy: ± 3 BPM or 10% whichever is greater (Predicate-I) | Range: 30 – 250 BPM | |
| Accuracy: ± 3 BPM or 5% whichever is greater | ||
| Respiration Rate | Range: 6-60 Breaths per Minute (Predicate-I); 4-40 Breaths per Minute (Predicate-II) | |
| Accuracy: ≤ 1 Breath per minute (MAE simulation), ≤ 3 Breaths per minute (MAE clinical) (Predicate-I); ± 3 Breaths per Minute (Predicate-II) | Range: 5-60 Breaths per Minute | |
| Accuracy: ≤ 1 Breath per minute (MAE simulation), ≤ 3 Breaths per minute (MAE clinical) | ||
| Skin Temperature | Range: 32.0°C – 43.0°C (89.6°F – 109.4°F) | |
| Accuracy: As per ASTM E1112-00 (Predicate-I) | Range: 15.0°C – 43.0°C (59.0°F – 109.4°F) | |
| Accuracy: As per ASTM E1112-00 | ||
| Body Temperature | Range: 32.0°C – 43.0°C (89.6°F – 107.6°F) (Predicate-II) | |
| Clinical Accuracy: ±0.3°C (Predicate-II) | Range: 32.0°C - 43.0°C (89.6°F - 109.4°F) | |
| Clinical Accuracy: -0.27 °C (Clinical Bias), 1.01°C (Limits of agreement) | ||
| SpO2% | Range: 40 to 100% (Predicate-II) | |
| Accuracy: ±2% (Predicate-II) | Range: 0 to 100% | |
| Accuracy: ± 3 % (100 to 70%), Less than 70% unspecified | ||
| Pulse Rate | Range: 40 to 250 BPM (Predicate-II) | |
| Accuracy: ± 3% (Predicate-II) | Range: 30 to 250 BPM | |
| Accuracy: ± 3 or 5% whichever is greater | ||
| Wear Life | 120 hours | 120 hours |
| Alerts/Alarms | Compliance with IEC 60601-1-8 (Ed. 2.2) (validated for visual alarm, alerts via email/SMS for primary visual alarm indication) | Compliance with IEC 60601-1-8 (Ed. 2.2) |
| Biocompatibility | According to ISO 10993-1: 2018 | Testing conducted according to ISO 10993-1:2018 (In-vitro cytotoxicity, skin irritation, skin sensitization) |
| Electrical Safety & EMC | Compliance with IEC 60601-1(Ed.3.2), IEC 60601-1-2 (Ed. 4.1), IEC 60601-1-11(Ed. 2.1) | Compliance achieved |
| Wireless Performance | Conformance to ANSI/IEEE C63.27:2017 | Conformance achieved for Single Patient Relay System & Multi-Patient Relay System |
| Software | IEC 62304 & USFDA Guidance (Class B, Moderate-Enhanced documentation), IEC 81001-5-1 | Designed, documented, verified & validated per specified standards |
| Shelf-life & Reliability | As per acceptance criteria | Testing conducted and verified |
| Packaging | As per ASTM D7386-16 | Testing conducted |
| Usability | Compliance with IEC 60601-1-6 (Ed. 3.2) and "USFDA Guidance- Applying Human Factors and Usability Engineering to Medical Devices." | Study conducted |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for all test sets. However, it does mention specific studies:
- SpO2% Accuracy: Clinical validation was performed to determine the accuracy of SpO2% with respect to SaO2 values from simultaneously drawn arterial blood as per ISO 80601-2-61 (Ed. 2.0). The specific sample size for this clinical validation is not provided in the summary.
- Body Temperature Accuracy: Validated using "non-randomized, self-control comparative on-body comparative performance with oral digital thermometer on multiple subject populations" in accordance with ISO 80601-2-56 (Ed.2.0). The specific number of subjects or populations is not provided.
- Wear-life Performance: Validated using "non-randomized, self-control comparative on-body comparative performance study for the wear period of 120 hours." The sample size for this study is not provided.
- Respiration Algorithm Improvement: Validated by comparing against "clinician manually scored end tidal CO2 (EtCO2) capnography, under spontaneous breathing & metronome breathing during normal activity conditions as part of wearlife study." The sample size is part of the wear-life study, but not explicitly stated.
Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether studies were retrospective or prospective. Given the FDA 510(k) submission, it is implied that the data is acceptable for the US market.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
The document indicates that for the respiration algorithm validation, the comparison was made against "clinician manually scored end tidal CO2 (EtCO2) capnography." This implies that clinicians (experts) were involved in establishing the ground truth. However, the exact number of experts and their specific qualifications (e.g., years of experience, specialty) are not provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1, none) for the test sets. For the "clinician manually scored" data mentioned for respiration, it's not specified if multiple clinicians scored and how discrepancies were resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any study evaluating the effect size of how much human readers (or healthcare professionals using the device) improve with AI vs without AI assistance. The device is a monitoring system that provides data and alerts, rather than an AI-driven diagnostic interpretation system typically evaluated with MRMC studies.
6. Standalone (Algorithm Only) Performance
The document describes specific performance tests for various parameters (e.g., heart rate, respiration rate, SpO2%, skin temperature, body temperature) that would inherently reflect the algorithm's performance in deriving these parameters from sensor data. For example:
- SpO2% accuracy was proven through "clinical validation to determine the accuracy of SpO2% with respect to SaO2 values from simultaneously drawn arterial blood." This implies a comparison of the device's output (algorithm only) to a gold standard.
- Body temperature accuracy was validated against an "oral digital thermometer."
- Respiration algorithm validation was against "clinician manually scored end tidal CO2 (EtCO2) capnography."
These tests demonstrate standalone performance metrics against established reference standards.
7. Type of Ground Truth Used
The types of ground truth used include:
- Physiological measurements from reference devices/standards:
- SaO2 values from simultaneously drawn arterial blood (for SpO2% accuracy).
- Oral digital thermometer (for Body Temperature accuracy).
- Bench testing standards (e.g., ASTM E1112-00 for skin temperature, ISO 80601-2-61 for Pulse Rate).
- Clinician-established ground truth:
- Clinician manually scored end tidal CO2 (EtCO2) capnography (for Respiration Rate algorithm).
8. Sample Size for the Training Set
The document does not explicitly state the sample size used for training the algorithms within the UbiqVue™ 2A Multiparameter System. It discusses validation of improved algorithms and additional features, but provides no detail on the development or training phase data.
9. How the Ground Truth for the Training Set Was Established
As the document does not provide details on the training set, it does not describe how the ground truth was established for the training set. It primarily focuses on the verification and validation (testing) of the final device/algorithms.
Ask a specific question about this device
(296 days)
LifeSignals, Inc.
The LifeSignals Multi-parameter Remote Monitoring Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include Electrocardiography (2-channel ECG), Heart Rate, Skin Temperature & Posture, Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage & analysis.
The LifeSignals Multi-parameter Remote Monitoring Platform is intended for non-critical, adult population.
The LifeSignals Multi parameter Remote Monitoring Platform can include the ability to notify healthcare professionals when physiological parameters fall outside the set limits and to display multiple patient physiological data for remote monitoring.
LifeSignals Multi-parameter Remote Monitoring Platform consists of four main components:
- (1) LifeSignals Multi-parameter Biosensor
- (2) LifeSignals Relay device (Software Application)
- (3) LifeSignals Secure Server (Software Application)
- (4) Web UI /Remote Monitoring Dashboard
- LifeSignals Multi-parameter Biosensor when attached body acquires two channel of ECG . signals, TTI respiration signals (one of the input for deriving Respiration Rate), resistance variation of a Thermistor attached to body (used for deriving Skin Temperature) & accelerometer data (input for deriving Respiration Rate & Posture), pre-processes them and wirelessly transmits to a paired Relay device (or any Receiver system). When Relay device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If Relay device is not available or if there is any interruption in the communication between Relay device and Biosensor, data shall be temporarily buffered locally in Biosensor till the wireless connection is re-established.
Biosensor Patch uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device.
- Relav Device manages wireless communication between LifeSignals Biosensor and ● LifeSignals Remote Secure Server. Relay device is a LifeSignals Relay Application software installed in a compatible commercial hardware platform, like a mobile phone or a tablet.
- LifeSignals Relay (Application) functions include: .
- . Manages secured wireless communication (WLAN 802.11b) between Relay device & Lifesignals Biosensor and encrypted communication between the Relay device and the LifeSignals Remote Secure Server.
- Receives physiological signals from the Biosensor and transmit them after encryption to Secure Server as quickly as possible. It manages the database in Relay device for buffering/storing the data securely, if there is any disruption in communication with the Secure Server.
- I Provides user interface for entering the Biosensor & Patient information and pairing & establishing connection with the Biosensor.
- . Provides User Interface to record any manual alert events by the patient.
- . Secure Server is a LifeSignals Secure Server Application software installed in Linuxcompatible Secure server hardware platform.
LifeSignals Secure Server Application manages the decryption, uploading and storage of Biosensor data received from multiple authenticated Relay devices. The "Sensor Processing Library" in LifeSignals Secure Server process, filter the received Biosensor data and derives Heart Rate, Respiration Rate, Skin Temperature & Posture before storing them in a secured location along with received Biosensor data, for access by Web UI or any 3rd-party applications for display or analysis purpose.
LifeSignals Secure Server Application shall have an optional ability to send alert notifications to any configured destination (email, SMS, WhatsApp), when the parameters (Heart Rate, Respiration Rate or Skin temperature) exceed the configured limits.
- . LifeSignals Web UI / Remote Monitoring dashboard is a web-browser User Interface Application that enable caregiver (Clinical personnel) to login to the LifeSignals Secure server remotely and access the patient physiological data (Biosensor & derived data) & Alert status. The caregiver (Clinical personnel) depending on the roles (normal or supervisory) can access multiple patient data and search them based on the recent alert status. This includes patients that are active (wearing Biosensor) and procedures completed.
Remote Monitoring Dashboard/Web UI shall also have an ability to continuously display physiological parameters (Heart Rate, Respiration Rate, Skin Temperature, Posture) & waveforms (ECG & Respiration) of multiple patients or single patient quasi-real time remotely on the screen for monitoring by caregiver (Clinical personnel).
This monitoring dashboard also has the ability for the caregiver (clinical personnel) to set the alert limits & notify address that configures the Secure server to send an alert notification to any Mobile Phone (SMS or WhatsApp) or Email ID of care giver, when parameters falls outside the set value.
Note: The Biosensor data may be accessible by a Third-Party Application installed in the Relay device using the Application Programming Interface (API) layer of the LifeSignal Relay Application Software, after suitable configuration and verification. In this configuration. LifeSignals Secure Server is optional and the data from Relay device shall be transmitted to a third-party server location. But the third-party server shall be installed with LifeSignals "Sensor Processing Library" for derivation Heart Rate, Respiration Rate, Skin Temperature & Posture.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text details performance testing but does not explicitly list quantitative acceptance criteria with corresponding reported values for all parameters in a single, clear table. However, the available information allows for a partial reconstruction of some performance aspects, particularly concerning accuracy for Heart Rate and Respiration Rate, and a general statement about meeting standards.
Based on the provided text, a table can be constructed for the most specific performance claims:
| Parameter | Acceptance Criteria (Stated) | Reported Device Performance (as validated) | Study Type Referenced |
|---|---|---|---|
| Heart Rate | 30 – 250 BPM (Range), ± 3 or 10% whichever is greater | (Implicitly meets stated criteria based on "accuracy performance validation") | On-body comparative performance ([K200690](https://510k.innolitics.com/search/K200690) validation applies) |
| Respiration Rate | Clinical: 9-30 Breaths/Minute with a mean absolute error of |
Ask a specific question about this device
(121 days)
LifeSignals, Inc.
The LifeSignals ECG Remote Monitoring Patch Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and Heart Rate monitoring in home and healthcare settings. Data is transmitted wirelessly from LifeSignals Biosensor Patch to Remote Secure for storage and analysis.
The LifeSignals ECG Remote Monitoring Patch Platform is intended for non-critical, adult population, who are 18 years of age or older.
The LifeSignals ECG Remote Monitoring Patch Platform includes an ability to notify healthcare professionals when Heart Rate falls outside the set limits.
LifeSignals ECG Remote Monitoring Patch Platform consists of three main components: (1) LifeSignals Biosensor Patch. (2) LifeSignals Relay device. (3) LifeSignals Remote Secure Server.
-
LifeSignals Biosensor Patch acquires ECG signals from the body, pre-processes as two channels of ECG data and are wirelessly transmitted to the Relay device. Under normal operation, when the Relay Device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If the Relay device is not available or if there is any interruption in the communication between the Relay device and the Biosensor Patch, data shall be buffered (stored) locally in the Biosensor Patch until the wireless connection is re-established.
Biosensor Patch uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device. -
Relay Device manages wireless communication between LifeSignals Biosensor and LifeSignals Remote Secure Server. Relay device is a LifeSignals Relay Application Software-installed compatible commercial hardware platform, like a mobile phone or a tablet.
-
LifeSignals Relay Application's functions:
- Manage secured wireless communication (WLAN 802.11b) between Relay device and Biosensor Patch and encrypts communication between the Relay device and the LifeSignals Remote Secure Server.
- Receive ECG signals from the Biosensor Patch and transmit them after encryption to Secure Server as quickly as possible. They manage the database in Relay device, for buffering/storing the data securely if there is any disruption in communication with the Secure Server.
- Provide user interface for selecting, pairing and establishing connection with Biosensor Patch.
- Display alert notifications received from the Secure Server when the Heart Rate of its associated Biosensor or of some other Biosensor in its network falls outside the configured range, when it is configured by the Secure Server to receive such notification.
-
LifeSignals Secure Server consists of a hardware platform that is a Linux-compatible Secure server, LifeSignals Secure Server Application software that is installed in the hardware platform along with a Web UI, a browser-based application that interfaces with LifeSignals Secure Server Application.
LifeSignals Secure Server Application manages the decryption, uploading and storage of Biosensor data received from multiple authenticated Relay devices. The Signal Processing and Heart Rate Library in the LifeSignals Secure Server Application processes and filters the received ECG signals before storing them in a secured location. It also derives the Heart Rate from the ECG data and the Heart Rate value is appended to the filtered ECG Signals.
LifeSignals Secure Server Application can include the ability to send alert notifications to any configured Relay Device connected in its network, when Heart Rate value of any Biosensor falls outside the set range of values.
Web UI provides user interface for user (login) management, Relay management & Heart Rate Alert setting. It interfaces with Secure Server Application.
-
The Secure Sever Application does not carry out any arrhythmia analysis of ECG data by itself. However, the ECG data received and stored by the LifeSignals Secure server is intended to be used with an approved third-party ECG analysis software. Based on the type of ECG analysis software, the LifeSignals ECG Remote Monitoring Platform can be used for a suitable clinical workflow such as a Remote Patient Monitoring, Mobile Cardiac Telemetry, Cardiac Event Monitor or Holter Monitoring system.
-
The ECG data may be accessible by a Third-Party Application installed in the Relay device using the Application Programming Interface (API) layer of the Relay Application Software, after suitable configuration and verification. In this configuration, LifeSignals Secure Server is optional and the data from Relay device shall be transmitted to a server location configured by the third-party application. Also, in this configuration, Signal processing and Heart Rate processing Library shall be integrated in third-party secure server application or in third-party relay application.
The provided text describes the acceptance criteria and study proving the device meets those criteria, specifically for the LifeSignals ECG Remote Monitoring Patch Platform (K200690).
Here's an organized breakdown of the information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative targets for each performance metric, nor does it provide detailed quantitative results for all reported device performance. Instead, it describes general compliance with standards and the methods used to verify performance against requirements, implicitly stating that acceptance criteria were met by passing these tests.
However, based on the comparison section, we can infer some key performance aspects:
| Feature/Metric | Predicate (K152139) (For comparison) | Acceptance Criteria (Inferred from regulatory standards and predicate comparison) | Reported Device Performance (K200690) |
|---|---|---|---|
| Heart Rate Range | 30 – 200 BPM | 30 – 250 BPM | 30 – 250 BPM |
| Heart Rate Accuracy | ± 5% or 10% whichever is greater | ± 3% or 10% whichever is greater (Improved accuracy compared to predicate) | ± 3% or 10% whichever is greater (Improved accuracy) |
| ECG Channels | Single channel | At least single channel; Device offers two for enhanced data | Two channels |
| Wear Life | 72 hours | 72 hours (Tested for adhesion according to AAMI ANSI EC12) | 72 hours |
| Electrical Safety | Not explicitly stated (Predicate Type BF) | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11; Applied Part: Type CF (lower risk) | Complies (Type CF) |
| EMC | Not explicitly stated | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Complies |
| ECG Waveform Quality | Implicitly meets standards | Performance testing for IEC 60601-2-47 and IEC 60601-2-27 compliance; Demonstrated good quality | Verified through comparative on-body performance study and compliance with IEC 60601-2-47/2-27 |
| Wireless Performance | Bluetooth (BT4.1) | Compliance with ANSI/IEEE C63.27:2017, FCC CFR47 Part 15 subpart C & ETSI EN 300 328 | Complies (WLAN 802.11b) |
| Biocompatibility | Not explicitly stated | Compliance with ISO 10993-1:2009 (In-vitro cytotoxicity, skin irritation, skin sensitization) | Complies |
| Usability | Not explicitly stated | Compliance with IEC 60601-1-6 and USFDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" | Complies |
| Software Validation | Not explicitly stated | Compliance with IEC 62304 and USFDA Guidance for software in medical devices (Class B, "Moderate" concern level) | Complies |
| Shelf-life & Packaging | Not explicitly stated | Verified as per acceptance criteria | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Ambulatory performance of Heart Rate algorithm and ECG waveform quality of LifeSignals ECG Remote Monitoring Patch Platform was verified using nonrandomized, self-control comparative on-body comparative performance study."
- Sample Size: The specific number of subjects for this "on-body comparative performance study" is not explicitly stated in the provided text.
- Data Provenance: The location where the study was conducted (country of origin of the data) is not explicitly stated. Given the manufacturer is based in Fremont, California, USA, and the FDA submission, it's highly probable the study was conducted in the USA, but this is an inference.
- Retrospective or Prospective: The study is described as a "comparative on-body comparative performance study," which suggests a prospective design where the device was used on subjects/patients.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts or a specific process for establishing ground truth for the test set data, particularly in the context of human readers reviewing ECGs. This suggests the primary "ground truth" for the device's performance metrics (like heart rate accuracy and ECG quality) was likely derived from:
- Comparison against established medical devices or gold-standard measurements concurrently obtained during the "on-body comparative performance study."
- Compliance with recognized international standards for ECG devices (IEC 60601-2-47 and IEC 60601-2-27).
4. Adjudication Method for the Test Set
Since the document does not describe a process involving human expert adjudication for the test set, there is no adjudication method (e.g., 2+1, 3+1) mentioned or implied. The performance validation seems to rely on technical measurement and comparison to established standards and potentially concurrently recorded data from reference devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a data acquisition and monitoring platform, not an AI-driven diagnostic algorithm that assists human readers in interpretation.
- Effect Size: N/A, as no such study was conducted or described.
6. Standalone (Algorithm Only) Performance
The device itself is a data acquisition and monitoring platform. While it includes "Signal Processing and Heart Rate Library" to process and filter ECG signals and derive Heart Rate, it is explicitly stated that:
- "The Secure Sever Application does not carry out any arrhythmia analysis of ECG data by itself."
- "No in-built arrhythmia analysis function and is intended to be used by any 3rd party arrhythmia analysis software."
Therefore, the concept of a "standalone (i.e. algorithm only without human-in-the-loop performance)" study in the context of diagnostic AI does not directly apply to this device. Its "performance" is in accurate data capture and heart rate calculation, which was verified through the "on-body comparative performance study" and compliance with electrical/performance standards.
7. Type of Ground Truth Used
The ground truth for validating the device's performance (heart rate accuracy, ECG waveform quality) appears to be derived from:
- Comparative Measurements: Likely against established, validated reference devices or methods during the "nonrandomized, self-control comparative on-body comparative performance study." This typically involves comparing the device's output to a known, accurate physiological measurement.
- Compliance with Industry Standards: Meeting the requirements specified in international standards like IEC 60601-2-47 and IEC 60601-2-27 for ECG devices. This implies that the standards themselves define acceptable ground truth performance levels.
There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth for this device's validation.
8. Sample Size for the Training Set
The document focuses on the performance verification of the device as a monitoring platform. It does not mention a "training set" or "training" process, indicating that this device is not an AI/Machine Learning model that would require such data for its development. The device performs signal acquisition and basic heart rate derivation, likely based on established signal processing algorithms rather than learned models.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set or an AI/ML model that requires training, the concept of "how the ground truth for the training set was established" is not applicable to the information provided for this device.
Ask a specific question about this device
Page 1 of 1