(82 days)
The TelZuit Cardiac Monitoring System consists of a 4-channel ECG (electrocardiograph) monitor (TelZuit Electrode Array Patch) and the TelZuit Cardiac Monitoring Recorder. The TelZuit Cardiac Monitoring Recorder stores and transmits data received from the TelZuit Electrode Array Patch via telephone to a remotely located ECG analysis station for evaluation by a medical professional.
The TelZuit Cardiac Monitoring System is a transtelephonic ambulatory ECG recorder consisting of the TelZuit Electrode Array Patch and TelZuit Cardiac Monitoring Recorder. These components, when used together, allow a patient to collect and transmit their ECG data to an analysis station for evaluation by a medical professional.
The TelZuit Electrode Array Patch is a multi-layer patch containing four embedded ECG electrodes and leads and a transmitter mounted on a Mylar substrate that is affixed to the patient's chest for monitoring ECG activity. Two models, Models A and B, are available that differ in lead placement and configuration. The electrode configuration in the TelZuit Electrode Array Patch Model A corresponds to positions of Lead I, Lead II, Lead III, and V2 for use with 12 Lead Algorithms. The electrodes in the TelZuit Electrode Array Patch Model B are positioned orthogonally so that the leads correspond to positions of EASI & G for use with Modified Frank Algorithms.
Each TelZuit Electrode Array Patch model is supplied in different sizes with lengths of 8.0, 8.5, 9.0, and 9.5 inches (203, 216, 229, 241 mm). The electrodes incorporated in all versions of the TelZuit Electrode Array Patch are identical to electrodes cleared for marketing by Bristol Medical Electronics, Inc., (K841944) and comply with ANSI/AAMI EC 12, "Disposable ECG Electrodes."
The TelZuit Cardiac Monitoring Recorder captures and stores digitized ECG data transmitted from the TelZuit Electrode Array Patch, and transmits this information to a remotely located receiving and analysis station via a modified Samsung Portable Dualband Tri-Mode personal digital assistant (PDA) with cellular telephone The device has a touchscreen LCD display. Recording and capabilities. transmission of ECG data occurs continuously while the TelZuit Electrode Array Patch and TelZuit Cardiac Monitoring Recorder are active. The patient may also record a cardiac event via the LCD display screen on the TelZuit Cardiac Monitoring Recorder. The TelZuit Cardiac Monitoring Recorder also continuously monitors the operational status of the TelZuit Cardiac Monitoring System and informs the user if an error is detected.
The provided 510(k) summary for the TelZuit Cardiac Monitoring System does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets particular performance metrics. Instead, it relies on general statements about compliance with industry standards and demonstration of accurate ECG tracing reproduction, primarily focusing on establishing substantial equivalence to predicate devices.
However, based on the information provided, we can infer some aspects and present the available data.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| ECG Tracing Reproduction | ECG tracings can be accurately and reliably reproduced from the signals transmitted by the TelZuit Cardiac Monitoring System. |
| Compliance with Standards | The TelZuit Cardiac Monitoring System complies with recognized industry standards for ambulatory ECG electrocardiograph devices. |
| Electrode Compliance | The electrodes incorporated in all versions of the TelZuit Electrode Array Patch are identical to electrodes cleared for marketing by Bristol Medical Electronics, Inc., (K841944) and comply with ANSI/AAMI EC 12, "Disposable ECG Electrodes." |
Study Details (Based on available information)
2. Sample size used for the test set and the data provenance:
- The document does not specify a particular sample size for a test set. The performance testing mentioned is broadly described, without details on the number of patients or recordings used.
- The data provenance is not mentioned. It is unclear if the data was retrospective or prospective, or from which country/region.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide information about experts involved in establishing ground truth for any test set, nor their qualifications. The system is designed for evaluation by a "medical professional," but this refers to the end-use scenario, not the validation study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify any adjudication method for a 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:
- The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a monitoring system that transmits raw ECG data for human evaluation, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply to this submission as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document does not describe a standalone algorithm performance study. The device functions as a data collection and transmission system, explicitly stating that data is sent "for evaluation by a medical professional." It is not an algorithmic diagnostic device, so a standalone algorithm performance would not be applicable to its stated function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not specify the type of ground truth used for any performance testing. Given the nature of an ECG monitoring system, ground truth would typically involve comparing the recorded ECG signals to a reference standard (e.g., a known, high-fidelity ECG capture system) or expert interpretation of the ECG waveforms themselves. However, these details are not provided.
8. The sample size for the training set:
- This device does not appear to involve a machine learning algorithm that would require a "training set" in the conventional sense. It's a hardware system for data capture and transmission. Therefore, no training set size is applicable or mentioned.
9. How the ground truth for the training set was established:
- As there is no apparent training set for a machine learning algorithm, no ground truth establishment method for a training set is applicable or mentioned.
Summary of Limitations in the Provided Information:
The 510(k) summary focuses heavily on establishing substantial equivalence based on intended use, general design, and compliance with recognized industry standards (like ANSI/AAMI EC 12 for electrodes). It does not delve into specific performance metrics, detailed study designs, sample sizes for validation, or the specifics of how "accurate and reliable reproduction" of ECG tracings was quantifiably demonstrated beyond a general statement. This type of submission, particularly for devices of this era (2003), often relied more on predicate device comparison and adherence to standards rather than extensive, quantitative clinical performance studies that are common for more complex diagnostic AI/ML devices today.
§ 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).