(146 days)
The GMP|Wireless Medicine LifeSync™ System is indicated for use when ECG monitoring is needed and a wireless cable-free connection is desired between the patient and the ECG Monitor. The LifeSync™ System will also transmit the patient respiration waveform for those ECG systems that include a respiration function.
The GMP/Wireless Medicine LifeSync™ System is intended for use as a radiofrequency signal transmitter and receiver of diagnostic electrocardiographic physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been validated for compatibility. ECG systems that are not currently wireless in operation will now be able to be used in a wireless fashion by virtue of being connected to the GMP system. The LifeSync™ System will also transmit the patient respiration waveform for those ECG systems that include a respiration function.
The GMPIWireless Medicine LifeSync™ System will eliminate the wires between the ECG patient and the ECG monitor and will replace the traditional ECG cable with a radio link. The GMP|Wireless Medicine LifeSync™ System will support the standard 5-lead ECG hook-up (via the Continuous Leadwear™) for monitoring and has the capability to add the remaining V1-V6 precordial leads (via the Discrete Leadwear™) for 12-lead discrete ECG recording.
The GMP|Wireless Medicine LifeSync™ System is comprised of 4 primary components and 1 accessory component: 1) a patient wearable 5-electrode array called the Continuous Leadwear™, 2) a patient wearable 6-electrode array called the Discrete Leadwear™, 3) LifeSync™ Patient Transceiver-with Armband , and 4) a LifeSync™ Monitor Transceiver. The accessory component is: 5) an optional Multi-Unit Battery Charger.
The LifeSync™ Patient Transceiver will be responsible for sampling ECG waveforms from the electrode array and converting these signals into digital data. It will then transmit this data over a wireless Bluetooth link to the Monitor Transceiver. The LifeSync™ Monitor Transceiver will reconstruct the analog signals from the received digital data and present these signals to the normal inputs of a standard Continuous Cardiac Monitor or Discrete Diagnostic ECG System. The LifeSync™ System has been validated for use with several ECG systems of various manufacturers.
The provided 510(k) summary for the GMP|Wireless Medicine LifeSync™ System does not contain detailed information regarding acceptance criteria or a specific study that proves the device meets such criteria in the way typically expected for AI/Machine Learning devices. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through conformity to established performance standards for ECG devices.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table format (e.g., "sensitivity > X%, specificity > Y%"). Instead, device performance is "accepted" if it conforms to the requirements of the listed industry standards. The reported performance is a general statement of compliance.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Conformance to ANSI/AAMI EC11-1991 | Met all applicable requirements |
| Conformance to ANSI/AAMI EC13-2002 | Met all applicable requirements |
| Conformance to ANSI/AAMI EC38-1998 | Met all applicable requirements |
| Conformance to ANSI/AAMI EC53-1995 | Met all applicable requirements |
| Conformance to EN 60601-1-1:1990 | Met all applicable requirements |
| Conformance to IEC 60601-1-2:2001 | Met all applicable requirements |
| Conformance to IEC 60601-2-27:1994 | Met all applicable requirements |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing described is "in-vitro performance testing" against standards, not a clinical study on a patient test set with specific sample sizes.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/not provided. Ground truth in the context of this device's testing relates to the established technical specifications and performance characteristics defined by the industry standards, rather than expert interpretation of medical images or signals.
4. Adjudication Method
This information is not applicable/not provided. As the testing focuses on technical compliance with standards, an adjudication method for conflicting expert opinions would not be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done and is not mentioned. The device is a signal transmission system, not an AI for interpretation that would typically involve human readers.
6. If a Standalone (Algorithm Only) Performance Study Was Done
The testing described is essentially "standalone" in the sense that the system (transmitter and receiver) was tested to ensure it accurately transmits ECG signals according to the technical requirements of the standards. However, it's not a standalone AI algorithm in the modern sense. The "algorithm" here refers to the signal processing and transmission capabilities of the device itself, rather than an AI interpreting the signals. The testing demonstrates that the device functions as intended without human intervention in its core signal transmission.
7. The Type of Ground Truth Used
The ground truth used for this device's testing is the objective technical specifications and performance requirements outlined in the referenced ANSI/AAMI and IEC standards. These standards define acceptable levels of signal accuracy, noise, frequency response, electrical safety, electromagnetic compatibility, etc., for ECG devices.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. The LifeSync™ System is a hardware device for signal transmission, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable. See point 8.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).