(142 days)
The event recorder, called the "CardioCall," is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms described to him by his physician. The CardioCall can either operate in the so-called "Looping" mode, in which it is always active, and in which it records a minute of one channel of cardiac activity before and a minute after the depression of the button; or in the "Post-Activation" mode, in which the device records two channels of cardiac activity for one minute after the depression of the record button. The PC computer program, called the "CardioConnect," is indicated when it is desired to transfer the memory of the event recorder into a computer by direct connection, instead of using transtelephonic means. The CardioCall recorder is indicated if it is desired to record the electrocardiogram at the time when a patient experiences intermittent or transient symptoms such as dizziness, palpitations, or shortness of breath, and the patient is capable of activating the recorder at these times.
CardioCall Event Recorder offers the user the choice of a looping cardiac event recorder (records the electrocardiogram both before and after the event) or a post-activation recorder (records the electrocardiogram only after the event). Inserting the patient cable automatically changes the system from post-activation to looping. Embedded electrodes in the case are used for post-activation recording. The unit records one channel in looping mode and two channels in post-activation mode, and has a maximum recording time of 20 minutes. In looping, the unit records ten events with one minute before and one minute after the event. Recordings can either be transmitted transtelephonically to a central station equipped with a standard transtelephonic receiver, or downloaded directly into a PC with the CardioConnect software, available as an option. The unit features a special battery conservation mode, to conserve battery power. While the device is compatible with a number of transtelephonic systems (the requirements are in the instruction book), all transtelephonic testing was done with the PaceArt receiving station.
Here's a breakdown of the acceptance criteria and study information for the Reynolds Medical CardioCall Event Recorder, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards (Medical Device) | CardioCall has been tested to meet medical device safety standards EN60601-1 and UL2601-1 (equivalent to IEC 601-1). It is CE marked for European EMC directive compliance. |
| Electromagnetic Compatibility (EMC) | EMC testing was performed by approved agencies. |
| Equivalent Performance to Predicate Devices | The CardioCall and predicate devices gave equivalent performance in tests on human volunteers. |
| No Adverse Events | No adverse events were reported in clinical tests on human volunteers. |
| Cytotoxicity of Embedded Electrodes | The embedded electrodes were tested for cytotoxicity. The steel specifications for the electrodes meet the British equivalent of ASTM Standard F899-95. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated, described as "a series of tests on human volunteers." The exact number of volunteers is not provided.
- Data Provenance: Clinical tests were conducted on "human volunteers." It's implied this was prospective as it describes the device being compared in new tests. The country of origin is not explicitly stated for the volunteers, but the submission is from a UK company, making it likely the tests were conducted there or in a setting associated with their operations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study focuses on comparing the CardioCall's performance to predicate devices and demonstrating equivalency, rather than establishing ground truth against an external diagnostic standard as might be done for an AI-driven diagnostic device.
4. Adjudication method for the test set
This information is not provided in the document. The study design centers on demonstrating equivalent performance between devices, not on resolving discrepancies in interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study design was a comparison of the device's performance to predicate devices, not an assessment of human reader improvement with or without AI assistance. The CardioCall is an event recorder that captures ECG data, not an AI-assisted diagnostic tool for human interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was effectively performed for the device itself in comparison to the predicate devices. The "tests are included comparing the CardioCall to the predicate devices using an ECG simulator" and "the CardioCall was compared to the predicate devices in a series of tests on human volunteers," implying an evaluation of the device's ability to record and, if applicable, transmit ECG data accurately, independent of direct human interpretive assistance during the recording process.
7. The type of ground truth used
The "ground truth" in this context is the performance of the legally-marketed predicate devices (Ralin Heart-Aide Event recorder and Braemar ER700 Event Recorder, K923930). The study aimed to demonstrate that the CardioCall's performance was "equivalent" to these established devices, both in terms of data acquisition and transmission, and the absence of adverse events.
8. The sample size for the training set
This information is not applicable as the CardioCall Event Recorder is not an AI-based device that would require a "training set" in the machine learning sense. It's a hardware device for recording ECGs.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above (not an AI-based device requiring a training set).
§ 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).