(87 days)
The ECG Telemedicine Option for the GEMS Series 4000 Communications Console is indicated for use when it is desired to communicate with distant medical devices in an EMS pre-hospital setting and to acquire and present information, such as single/12lead ECG and physiologic/non-physiologic data, or other physiologic information which has been gathered by these devices.
The EMS Telemedicine Option is an optional element of the GEMS Series 4000 communications console which provides the means for performing telemedicine functions, namely, communicating with and presenting information acquired from distant medical devices. The GEMS Series 4000 communications console is a standard radio/telephony communications console used for voice and data communications. The GEMS Series 4000 communications console, without the EMS Telemetry Option is marketed for non-medical applications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e.; 2-way radio equipment, landline and wireless telephone) as which are commonly used for commercial and public safety (i.e.: police, fire and EMS) communications purposes. With the EMS Telemedicine Option, the console can perform medical functions, such as communicating physiologic information (i.e .: single/12-Lead ECG and physiologic/non-physiologic data) with distant medical devices. The signal processing means employed for this includes: frequency modulation (FM), which is commonly used in EMS ECG telemetry applications; DTMF (touch-tone) signaling, which is commonly used for telecommunications signaling: Frequency Shift Keying (FSK), which is commonly used for data communications; as well as standard digital communications schemes such as modulation/demodulation (modem) communications. It also provides for the display and printing of physiologic information, such as single and 12-Lead ECG, and non-physiologic data, such as EMS Run ID, patient name, time of day, etc. The EMS Telemedicine Option consists of hardware and software elements that are installed into the GEMS Series 4000 communications console. These hardware & software elements convert received information into a digital form compatible with standard PC functions, such as information presentation by a CRT monitor and hardcopy printouts. Signal processing is performed by a printed circuit board (PCB) that plugs into the console's PC Mother Board. The EMS Telemedicine Option's features and functions are similar to those found in this type of equipment, including the predicate devices (GEMS Series 2000 and Rosetta-Rx). The digital and analog technologies employed by the above stated purposes are commonly employed for this purpose and are well understood. The functioning of the heart rate meter and the performance of the demodulator/signal processing and display elements conform to ANSI/AAMI EC11-1991.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EMS Telemedicine Option:
It's important to note that the provided text is a 510(k) premarket notification summary from 2002. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical trial data with detailed acceptance criteria and performance metrics typically seen in studies for novel high-risk devices.
Based on the information given, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a dedicated table. Instead, it describes general performance requirements that are met by the device. The reported performance refers to the successful outcome of these non-clinical tests.
| Acceptance Criteria (Implied from Study Goals) | Reported Device Performance (as stated in the document) |
|---|---|
| Ability to correctly and accurately communicate desired information from the acquisition device under simulated use conditions | System successfully performs the intended task under normal use conditions, demonstrating reliable and accurate reception and reconstruction of physiologic information. |
| Ability to correctly convert gathered information to the desired communications scheme under simulated use conditions | System successfully performs the intended task under normal use conditions, demonstrating reliable and accurate reception and reconstruction of physiologic information. |
| Efficacy of the intended transmission schemes under simulated use conditions | System successfully performs the intended task under normal use conditions, demonstrating reliable and accurate reception and reconstruction of physiologic information. |
| Ability to correctly and accurately acquire information from the transmission means under simulated use conditions | System successfully performs the intended task under normal use conditions, demonstrating reliable and accurate reception and reconstruction of physiologic information. |
| Ability to correctly convert gathered information for presentation by the desired presentation means and accurately present this information under simulated use conditions | System successfully performs the intended task under normal use conditions, demonstrating reliable and accurate reception and reconstruction of physiologic information. |
| Conformity to ANSI/AAMI EC11-1991 for heart rate meter functioning and demodulator/signal processing/display elements | The functioning of the heart rate meter and the performance of the demodulator/signal processing and display elements conform to ANSI/AAMI EC11-1991. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document refers to "simulated use conditions" and "non-clinical testing" but does not quantify the number of tests performed or any data points.
- Data Provenance: The study was a "non-clinical testing" under "simulated use conditions." This implies it was conducted internally by the manufacturer. The country of origin for the data is not explicitly stated. The nature of the tests suggests it was prospective testing of the device's functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. This was a non-clinical, functional and performance test against established engineering standards (ANSI/AAMI EC11-1991) and expected behavior, not an expert-driven diagnostic study.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Since this was a non-clinical performance and functional verification study, there was no need for human adjudication of results in the diagnostic sense. The "ground truth" was the expected correct functioning according to design specifications and relevant standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This document describes a non-clinical performance evaluation of a communication and display system for physiological data, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in a sense. The testing described primarily focuses on the standalone performance of the device's components (hardware and software) in accurately receiving, demodulating, converting, and displaying physiological information. The "human-in-the-loop" would be using the display, but the core functionality being tested is the automated processing by the device itself to conform to standards and reconstruct the received data correctly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: The ground truth for the non-clinical tests appears to be:
- Established engineering standards: Specifically, ANSI/AAMI EC11-1991 for the heart rate meter and demodulator/signal processing/display elements.
- Expected correct output/behavior: The device was tested to ensure it "correctly and accurately" communicated, converted, acquired, and presented information as designed, implying comparison against a known, accurate input signal or data.
8. The sample size for the training set
- Sample Size: Not applicable. This type of device (an ECG demodulator/display) is not typically "trained" in the way a machine learning or AI model would be. Its functions are based on fixed algorithms and hardware components.
9. How the ground truth for the training set was established
- Ground Truth for Training: Not applicable. As mentioned, this device does not use a training set in the context of machine learning. Its functionality is based on established engineering principles and protocols for signal processing and communication.
§ 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).