(87 days)
The CardioBeeper® CB-12L is intended to condition an electrocardiograph signal so that it can be transmitted via a telephone line to a remote location. The CB-12L is designed to be used by a patient to transmit a rhythm strip or a 12 lead ECG signal in real time to a physician's office, hospital or other medical receiving center. Note that due to the discrete options for selecting the precordial electrode positions, the CB-12L transmission may only approximate a standard 12 lead ECG for some patients.
The CardioBeeper® CB-12L is a compact, hand-held, battery-powered, single channel transtelephonic ECG transmitter that is capable of transmitting a 24 second rhythm strip or a 45 second 12 lead ECG. The CB-12L consists of a transmitter/ electronics module (TEM), two limb electrodes (RA and LL) attached to the TEM via separate cables, and a chest belt containing the third limb electrode (LA) and thirteen silver silver-chloride electrodes. Prior to a patient using the CB-12L, the patient's physician must select the six most appropriate chest belt electrodes to function as the precordial V1-V6 electrodes according to the patient's chest size.
The provided text describes a 510(k) submission for the CardioBeeper® CB-12L, a telephone electrocardiograph transmitter. Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric sense for the device's diagnostic capabilities. Instead, it frames the study as comparing the "diagnostic quality" of ECGs. The performance is reported in qualitative terms of "comparability."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Diagnostic Quality (12-lead ECG): ECGs produced by the CB-12L should be comparable in diagnostic content to those recorded using a standard 12-lead ECG system. | The results of the study showed that the ECGs transmitted using the CB-12L were comparable in diagnostic content to those recorded using a standard 12 lead machine. |
| User Capability (Unsupervised Transmission): Patients, after appropriate training, should be capable of applying electrodes and transmitting a quality 12-lead ECG tracing without direct medical supervision. | The results confirmed that the patients were capable of applying the electrodes and transmitting a quality 12 lead ECG tracing without direct medical supervision following appropriate training in the use of the CB-12L. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 97 patients
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that it was a "clinical study," it implies a prospective data collection, but this is not explicitly confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used, their qualifications, or how they established the ground truth for the test set. It only mentions the comparison of diagnostic quality.
4. Adjudication Method for the Test Set:
The document does not provide any information about the adjudication method used for the test set.
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:
This is not applicable. The CardioBeeper® CB-12L is a device for transmitting ECG signals, not an AI or diagnostic interpretation tool. The study focuses on the quality of the transmitted signal and the patient's ability to use the device, not on improving human reader performance with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable in the context of an "algorithm only" performance because the device's primary function is signal transmission, not autonomous diagnostic interpretation. The study evaluates the device's functionality and the patient's ability to use it.
7. The Type of Ground Truth Used:
The "ground truth" for the diagnostic quality comparison was established by using "a standard 12 lead ECG system." The study compared the diagnostic content of the CB-12L's ECGs against these standard ECGs. The document doesn't specify if this "standard" was interpreted by expert consensus, or if there was subsequent pathology or outcomes data.
8. The Sample Size for the Training Set:
The document does not mention a "training set" in the context of an algorithm or AI model development. The 97 patients appear to be the subjects of the clinical study, which evaluates the device's performance directly.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no mention of a training set for an algorithm.
§ 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).