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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:

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document does not explicitly state the sample size used for the performance testing (test set). It mentions "non-randomized, self-control comparative on-body comparative performance study" for wear-life validation and for ECG & Heart Rate accuracy. For Respiration Rate, it mentions "on-body comparative performance" and "bench testing." No specific number of subjects or cases is provided.
• Data Provenance: The document does not specify the country of origin for the clinical study data. It refers to "clinical studies" and "on-body comparative performance," implying human subject data. It also mentions "bench testing" and "simulation studies." The nature of the studies ("comparative on-body comparative performance") suggests they are prospective, but this is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth:

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for the test set. It mentions "healthcare professionals" and "clinical personnel" in the context of device use, but not for ground truth establishment for the studies themselves.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or evaluating the test set.

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

• The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance.
• The device described is a remote monitoring platform that collects and transmits physiological data, offering parameters like ECG, Heart Rate, Respiration Rate, Skin Temperature, and Posture. Its primary function is data acquisition, transmission, display, storage, and analysis, with an optional alert notification system. It is not an AI-assisted diagnostic imaging device for which MRMC studies are typically performed to assess reader improvement.
• Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in the context of the studies described for this device.

6. Standalone (Algorithm Only) Performance:

• The document describes performance testing for various physiological parameters (ECG, Heart Rate, Respiration Rate, Skin Temperature). These tests evaluate the device's ability to accurately measure and derive these parameters from raw biosensor data.
• Specifically, it states that the "Sensor Processing Library" in the LifeSignals Secure Server processes and filters biosensor data to derive Heart Rate, Respiration Rate, Skin Temperature & Posture.
• The performance validations conducted (e.g., for Heart Rate accuracy, Respiration Rate performance, Skin Temperature accuracy) essentially assess the "algorithm-only" or "device-only" performance in accurately capturing and processing physiological signals, as this is the core function of the device before human interpretation of the displayed data.

7. Type of Ground Truth Used:

The types of ground truth used can be inferred from the testing methods:

• Physiological Measurements: For Heart Rate, Respiration Rate, and Skin Temperature, the ground truth would likely be established through reference devices or highly accurate clinical measurement standards. For example, "on-body comparative performance" implies comparison against a gold standard in a clinical setting, and "bench testing" implies comparison against known, controlled inputs.
• ECG Waveform Quality: Ground truth would involve comparison against standard ECG recordings, likely by visual inspection or automated analysis according to established medical device standards (e.g., ANSI AAMI IEC 60601-2-47).
• Biocompatibility/Safety/Usability: Ground truth for these aspects is compliance with relevant national and international standards (ISO, ANSI AAMI, IEC, USFDA Guidance).

The document does not explicitly state "expert consensus," "pathology," or "outcomes data" as ground truth methods beyond the functional performance against established standards.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This device is described as a physiological monitoring system that captures and processes signals, rather than a deep learning model that typically requires a large training dataset. While software is involved (Class B, "Moderate" level of concern), the text focuses on verification and validation of the software and derived parameters against known physical and physiological principles, rather than a machine learning training paradigm.

9. How Ground Truth for the Training Set was Established:

As no training set is mentioned in the context of machine learning, no information is provided on how its ground truth was established. The "Sensor Processing Library" mentioned suggests signal processing and derivation algorithms, which are typically validated through known physiological models, bench test data, or clinical reference measurements, rather than a large, retrospectively labeled training set in the AI sense.

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