(258 days)
The PhysioGlove ET is intended for self-testing by patients and by health care professionals at home and at medical settings. This 12-lead electrocardiogram (ECG), allows remote patients to display and transmit their ECG data to medical professionals via a mobile platform (communication device) to a remote server.
Specifically, the PhysioGlove ET is intended for patients who are concerned about their heart health and have the following problems that are suggestive of abnormal heart function:
- · Skipped beats
- · Pounding heart (palpitations)
- · Heart racing or irregular pulse
- · Lightheadedness or faintness
- · Chest discomfort
- Shortness of breath
- · High risk for heart problems
- · History of heart problems
- · Recipient of heart medications
The system only provides waveform parameters for healthcare provider interpretation and does not provide suggested interpretations.
The PhysioGlove ET system is a 12-lead electrocardiograph capable of recording and transmitting standard ECGs for the purpose of cardiac monitoring and diagnosis in a remote location. The PhysioGlove ET system consists of the following 3 primary components:
The PhysioGlove - a glove that incorporates a system of Ag/AgCl electrodes for use in recording 12-lead ECGs. The PhysioGlove of the ET system is a modification of the cleared PhysioGlove ES-1 system (originally cleared under K083677 and later incorporated under K103791). In the ET system, however, the PhysioGlove encompasses also electronic elements (mainly a data acquisition circuitry and software packed into the glove, based on the cleared PhysioGlove ES-1) and a recording and transmitting circuitry to permit the transfer of the ECG data to a mobile platform.
The Mobile Platform Software - designed to be downloaded to a compatible mobile platform such as a smart cell-phone, a tablet computer, or another communication device. The proprietary Mobile Platform Software is responsible to provide the user with the PhysioGlove ET system operational instructions, as well as to receive the ECG data from the PhysioGlove and to transfer them to the receiving center. No graphical presentation of the acquired ECG is enabled on the mobile platform.
The Mercury Telemedicine System (MTS) - proprietary software designed to be installed on a computer in the PhysioGlove ET receiving center (e.g., Nurse Station). The MTS is responsible to receive the recorded ECG data, save it in a database and present it to a medical professional who is capable of interpreting the results. The MTS is based on the PhysioGlove ES-1 software (originally cleared under K050674 and later incorporated under K103791).
The PhysioGlove ET system operates as follows:
The PhysioGlove records the patient's ECG and sends the data via Bluetooth to a mobile platform. Then, the recorded data is automatically transferred via the Internet using Wi-Fi to connect to a modem or via GPRS cellular communication. The data is sent to a receiving center (e.g., Nurse Station) to be reviewed by a medical professional who is capable of interpreting the ECG data.
The PhysioGlove ET system is an electrocardiograph device for recording and transmitting 12-lead ECGs for remote cardiac monitoring and diagnosis. The information provided outlines the system's performance testing.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Functions as expected |
| Electromagnetic Compatibility | IEC 60601-1-2 | Functions as expected |
| Performance - Home Healthcare Environment | IEC 60601-1-11 | Functions as expected |
| Performance - Electrocardiographs | IEC 60601-2-25 | Functions as expected |
| Software Validation | Not specified | Functions as expected |
| Usability | Not specified | Functions as expected |
2. Sample Sizes and Data Provenance:
The provided document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the performance testing. It only mentions that "Performance testing was conducted."
3. Number and Qualifications of Experts for Ground Truth:
There is no information provided regarding the number of experts used to establish ground truth or their qualifications. Given the nature of the testing (compliance with electrical and performance standards, software validation, and usability), it is expected that qualified engineers and technical personnel would have conducted and assessed these tests, but specific details are not present.
4. Adjudication Method:
No information is provided about an adjudication method. The performance testing appears to be focused on meeting specified engineering and usability standards rather than expert-based clinical adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is made. The study described focuses on the device's technical performance and compliance with standards, not on the improvement of human reader performance with or without AI assistance. The device explicitly states: "The system only provides waveform parameters for healthcare provider interpretation and does not provide suggested interpretations." This implies the device is a data acquisition and transmission tool, not an AI-assisted interpretation device.
6. Standalone (Algorithm Only) Performance Study:
No standalone (algorithm only) performance study is described. The PhysioGlove ET system is designed to provide waveform parameters for human interpretation, not to provide automated interpretations itself. The "SW validation testing" likely refers to the software's functional correctness in data acquisition, transmission, and display, rather than its interpretive accuracy.
7. Type of Ground Truth Used:
The ground truth used for the performance testing appears to be the compliance with specific international standards for medical electrical equipment and electrocardiographs (IEC 60601 series), as well as the expected functionality in terms of software operation and usability. This is a technical ground truth based on established engineering and regulatory benchmarks, rather than clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set:
No information is provided regarding a training set sample size. This is consistent with the nature of the device as a data acquisition and transmission system rather than an AI/machine learning model that typically requires a training set for developing its interpretive capabilities. The "PhysioGlove of the ET system is a modification of the cleared PhysioGlove ES-1 system" and "The PhysioGlove ET SW is a modification of the cleared PhysioGlove ES-1 SW," suggesting an iterative development process rather than de novo AI training.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a traditional "training set" for an AI model, there is no information on how its ground truth would have been established. The development seems to be based on modifications of previously cleared devices, implying that the foundational "ground truth" relates to the established technical specifications and performance of the predicate devices.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).