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510(k) Data Aggregation
(110 days)
The TelEnable EMS System provides a mechanism to transmit 12-lead ECGs from a portable ECG monitor to a central location such as a hospital. This system connects to the ECG via a standard POTS (Plain Old Telephone System) interface and communicates to the ECG via standard Group 3 facsimile (fax) protocol.
The TelEnable EMS System provides a means of transmitting snapshots of physiologic waveforms and data over standard communications means such as the public switched telephone, analog cellular, or digital cellular networks. Such information is transmitted from a remote location using the EMS-Enable component to a receiving EMS Hub component located in a hospital.
The EMS-Enable component connects to portable ECG & standard monitor/defibrillator devices that can output their data via a standard fax modulator (modem). The EMS-Enable decodes the touch tone dialing digits output by the monitor to determine which hospital to call. This analog information is converted into encrypted data packets that are suitable for transmission over digital and analog networks. The EMS-Enable is a self-contained, battery-powered device that is connected to a cell phone via a standard data cable compatible with the phone and a standard telephone adapter cable.
Standard fax output from the ECG monitor/defibrillator device is received by the EMS-Enable (as if was a standard telephone wall plug). The data is encrypted and converted into data packets to be transmitted over the digital cellular or other standard communication network. The EMS-Enable transmits the data packets over the communication network to the EMS Hub where the ECG fax can be printed out on a standard printer, saved in a data file, or printed out on a standard fax machine.
The EMS Hub component is located in the hospital and provides the interface between the remote EMS-Enable devices and the hospital. It is connected to the Public Switched Telephone Network (PSTN or standard telephone network) via standard telephone patch cables. It communicates with the EMS-Enable and depacketizes and decrypts the ECG fax into a format compatible with a printer, file, or standard fax machine.
The transmission formats supported by the EMS-Enable and EMS Hub include standard group 3 fax modulation formats, touch-tone signaling (DTMF), and standard interface protocols and schemes utilized by cell phones and cell phone carriers to transmit data.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TelEnable EMS System:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be >95%"). Instead, the testing focuses on functional verification and reliability under simulated conditions. The reported "performance" is a qualitative statement of successful operation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| EMS-Enable: | |
| Correctly and reliably receive standard fax formatted information. | Verified: "EMS-Enable could correctly and reliably received standard fax formatted information. These tests were performed under simulated use conditions and using standard fax machines as input devices." |
| Correctly and reliably connect to and communicate with standard communication devices (digital cell phone, land line). | Verified: "EMS-Enable can correctly and reliably connect to and communicate with the standard communication devices. The specific devices tested were digital cell phone and land line connection." |
| Correctly and reliably transmit packetized and encrypted fax information. | Verified: "EMS-Enable can correctly and reliably transmit the packetized and encrypted fax information. These tests were performed under simulated use conditions." |
| Reliably receive, encrypt, packetize, and send received fax information in a format compatible with EMS Hub. | Verified: "EMS-Enable can reliably received, encrypt, packetize, and send the received fax information in the format compatible with the EMS Hub. These tests were performed under simulated use conditions." |
| EMS Hub: | |
| Correctly receive packetized and encrypted data. | Verified: "EMS Hub can correctly receive the packetized and encrypted data. These tests were performed under simulated use conditions." |
| Correctly and reliably decrypt and output fax data to standard printer, file, and fax machines. | Verified: "EMS Hub can correctly and reliably decrypt and output the fax data transmitted from the EMS-Enable. The outputs were to standard printer, file, and fax machines. These tests were performed under simulated use conditions." |
| System (EMS-Enable & EMS Hub): | |
| Efficacy under simulated wireless signal dropout and signal-corruption conditions. | Determined: "Determined the efficacy of the EMS-Enable and EMS Hub under simulated wireless signal dropout and signal-corruption conditions. These tests were performed under simulated use conditions." (Efficacy is not explicitly stated but implied as satisfactory to meet substantial equivalency). |
| Reliable and correct transmission and faithful reproduction of physiologic information. | Verified: "The testing... demonstrates that the system is substantially equivalent to the predicate devices in that the physiologic information (snapshots are encoded by an external monitor and output as a standard fax) was reliably and correctly transmitted and faithfully reproduced on the output device." |
| Successful performance of intended tasks under normal use conditions. | Concluded: "The TellEnable EMS System can successfully perform the intended tasks under normal use conditions; that the system behaved as expected; that the application of standard communication technologies in this environment can achieve predictable results; and the absence of electrical risk factors to the patient." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The description only states "these tests were performed under simulated use conditions" and mentions using "standard fax machines as input devices" and specific communication devices like "digital cell phone and land line connection." It doesn't quantify the number of transmissions, runs, or specific data points used for these tests.
- Data Provenance: The data appears to be prospective as it involves non-clinical trials conducted specifically for this submission. The "country of origin of the data" is not explicitly stated but is implied to be within the United States, given the submitter's location and FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The tests described are functional and reliability validations of data transmission and reproduction, not diagnostic performance. There is no mention of human expert review being used to establish a "ground truth" for the test set in the context of medical interpretation. The device's function is to transmit ECG faxes, not to interpret them. The "ground truth" for these tests would essentially be the original fax data input to the EMS-Enable and its accurate reproduction by the EMS Hub.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are functional and reliability validations. There's no mention of conflicting interpretations requiring adjudication. The assessment would likely have been against the expected output data.
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
Not applicable. This device is a communication system for transmitting faxes, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance improvement are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The non-clinical trials describe the performance of the TelEnable EMS System purely as a standalone system (EMS-Enable and EMS Hub) transmitting data. There is no human intervention or interpretation within the system's function itself. The "human-in-the-loop" would be the initial operator sending the ECG fax and the recipient viewing/printing it, but the device's performance evaluation focuses on the automated transmission process itself.
7. The Type of Ground Truth Used
The ground truth used for these functional tests would be the original standard fax output from the ECG monitor/defibrillator device. The verification checks would compare the received and outputted fax data (printed, filed, or faxed) against this original content for fidelity and accuracy of transmission and reproduction. It is not pathology, outcomes data, or expert consensus in a diagnostic sense.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware and software system for data transmission, not a machine learning or artificial intelligence algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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