Search Results

The eMotion ECG sensor is a wearable, portable, externally applied, electrocardiograph recorder and transmitter for the purpose of health monitoring, biofeedback and scientific research. The eMotion ECG Mobile is intended for use in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug-in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The eMotion ECG Mobile does not provide any automatic analysis or diagnosis.

The eMotion ECG Mobile is a mobile device, PC and Internet based telemetry solution for the ambulant monitoring of the plug-in device data of chronic patients via a mobile network. Plug-in devices can be ECG devices, blood pressure monitors, weighing scales, etc. The device reads data from the plug-in device via a Bluetooth connection. The application in the mobile device sends the data to a server (Health Gateway) over mobile networks using the secured connection. Data can be viewed from the Health Gateway server using the Web Monitor. Monitoring is performed using PC application that reads data from the server over the internet using the secured connection.

The Mega Electronics Ltd eMotion ECG Mobile is a device designed for the ambulatory monitoring of chronic patients by collecting and transmitting health parameters from plug-in devices (e.g., ECG sensors, blood pressure monitors, weighing scales) to healthcare professionals. The device itself does not provide automatic analysis or diagnosis.

Here's an analysis of its acceptance criteria and the study that proves it meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The Study Proving Acceptance Criteria are Met:

The device's performance was evaluated through non-clinical performance data (laboratory testing and verification/validation processes).

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify a distinct "test set" in terms of patient data or clinical cases. Instead, the testing appears to be based on a single device or a set of devices undergoing various laboratory-based performance and safety tests.
• Data Provenance: The data is generated from non-clinical performance testing conducted by the manufacturer, Mega Electronics Ltd., in Finland. This is prospective data generation from device testing, not retrospective clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This information is not provided as the study is a non-clinical device performance and safety verification, not a clinical study involving expert interpretation of patient data. The "ground truth" here is adherence to engineering specifications and recognized consensus standards (e.g., EN 60601-2-25:1999).

4. Adjudication Method for the Test Set:

• This is not applicable as there was no clinical test set requiring expert adjudication. The "adjudication" in this context would be the pass/fail determination based on predefined engineering and safety specifications within the written test protocols.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
• The device explicitly states: "The eMotion ECG Mobile does not provide any automatic analysis or diagnosis." Therefore, there is no AI component providing interpretations that would be compared with or assisting human readers. The device serves solely as a data collection and transmission tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Yes, in a sense, a standalone performance evaluation was conducted for the device's technical specifications. However, it's critical to reiterate that the "eMotion ECG Mobile does not provide any automatic analysis or diagnosis." Therefore, this standalone performance refers to the accuracy and reliability of its data acquisition and transmission capabilities, not the performance of an AI algorithm in interpreting medical data. The performance tests (e.g., A/D conversion, sampling rate, noise, CMRR, waveform shape) represent the standalone technical performance of the device's hardware and embedded software for data capture.

7. Type of Ground Truth Used:

• The ground truth used for the non-clinical performance data is based on engineering specifications, recognized consensus standards (e.g., EN 60601-2-25:1999), and pre-defined pass/fail criteria established in written test protocols. For the connectivity with plug-in devices, the ground truth was "proper functioning" and successful data transmission with those specific commercial devices.

8. Sample Size for the Training Set:

• This is not applicable. The eMotion ECG Mobile does not employ machine learning or AI algorithms that would require a training set for diagnostic or analytical purposes. It is a data collection and transmission device.

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

• This is not applicable as there is no training set for an AI algorithm.

Ask a specific question about this device