(158 days)
These devices are intended for use by patients who need to record their ECG during daily activites for subsequent transmission to a clinic, service, or hospital. These patients may have been instructed by their physician to record their ECG for the purpose of documenting transient symptoms which may suggest cardiac arrhythmia. The telephonic use of these devices allows the patient to receive advice based on their ECG and symptoms in a timely manner.
These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment followup, where such symptoms may be present.
The accelerated transmission protocol may be used by transtelephonic ECG transmitters. This protocol allows the stored ECG data to be sent more rapidly over the communications link to the receiver. Three devices that incorporate the Advanced Transmission Protocol (ATP) are presented in this summary statement. They are the King Of Hearts, Express ATP. the King Of Hearts, Prince ATP, and the HeartCard ATP.
These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment followup, where such symptoms may be present.
Features and functions are identified to the identified predicate devices with the addition of the ATP feature. The Accelerated Transmission Protocol feature does not play any part in the recording of ECGs. It is only active in the transmit mode. The ATP feature accelerates the transmission rate to 3 times the rate the data was acquired. The transmitters convert the data to an FM signal, which is sent to a receiver (LRC 2000 Receiver) designed to receive the ATP protocol. The receiver demodulates the FM signal back to the analog ECG waveform, and expands the received signal to the original scale by using an increased sampling rate (3x) and operating the chart drive at a 3x rate. The result is a chart strip showing the time scale of the original signal acquisition. The edge print on the ECG strip indicates that an accelerated transmission has been received from an Instromedix transmitter.
Due to the limited information provided in the input, a comprehensive description of acceptance criteria and a study proving device performance, as typically required for contemporary medical device submissions, cannot be fully generated. The provided text is a "Summary Of Safety And Effectiveness" from 1996 for an "Accelerated Transmission Protocol (ATP)" for transtelephonic ECG transmitters, focusing primarily on the transmission aspect rather than diagnostic performance of the ECG recording itself.
The document implicitly defines the acceptance criterion for the ATP feature as its ability to transmit ECG data at an accelerated rate (3 times the acquisition rate) while maintaining the original scale and integrity of the ECG waveform upon reception.
Here's an attempt to structure the information based on the provided text, highlighting what is present and what is missing:
Description of Acceptance Criteria and Study to Prove Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Item | Reported Device Performance |
|---|---|
| Accelerated Transmission Rate | The ATP feature accelerates the transmission rate to 3 times the rate the data was acquired. |
| Maintenance of Original ECG Scale and Integrity | The receiver demodulates the FM signal back to the analog ECG waveform and expands the received signal to the original scale by using an increased sampling rate (3x) and operating the chart drive at a 3x rate. The result is a chart strip showing the time scale of the original signal acquisition. |
| Indication of Accelerated Transmission | The edge print on the ECG strip indicates that an accelerated transmission has been received from an Instromedix transmitter. |
| Safety and Effectiveness Equivalence (Implicit) | The safety and effectiveness of these devices using ATP is substantially equivalent to the predicate devices. The ATP feature does not play any part in the recording of ECGs and is only active in the transmit mode, implying no degradation of ECG recording quality. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document primarily focuses on the technical aspects of transmission, not diagnostic interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of the ATP feature (data transmission), it's unlikely a traditional diagnostic adjudication method for ECG interpretation was used for this aspect. The "ground truth" would likely be the accurate reproduction of the original ECG waveform.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done based on the provided text. The device's primary function described here is accelerated transmission, not aiding human readers in diagnosis. Therefore, a study on human reader improvement with AI assistance is not relevant to this specific submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: The description of the ATP feature and its functioning (encoding, transmission, decoding, and reproduction of the ECG waveform) inherently describes a standalone algorithmic performance. The device's ability to transmit and reproduce the ECG at the described speed and fidelity is its standalone performance. No human-in-the-loop is involved in the acceleration and reproduction process itself.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the transmission aspect would be the original ECG waveform as acquired by the device before transmission. The acceptance criteria imply that the received and expanded ECG waveform should accurately reflect this original.
8. The Sample Size for the Training Set
- Sample Size: Not applicable/not specified. The ATP is a protocol/feature for data transmission, not a learning algorithm that requires a training set in the typical machine learning sense. Its functionality is hard-coded based on signal processing principles.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. As mentioned above, this is a protocol based on signal processing, not a machine learning model requiring a training set with established ground truth. The "ground truth" here is the mathematical and electrical integrity of the signal transmission and reproduction.
§ 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).