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This monitoring system is intended to be used by clinicians for ECG signals monitoring of ambulatory and nonambulatory adult and pediatric patients in health care facilities. This product is intended to be used by trained health care professionals. It is not intended for home use.

The BeltBeat is a comprehensive ambulatory system solution for ECG monitoring in intermediate care units for adult and pediatic patients. The foundation of the system is a transmitter (BeltBeat WF400) that can capture and transmit ECG signals that are then processed and displayed on the Information Center (BealtBeat STC). The Information Center generates alarms and recordings, thus notifying clinicians of changes in patients' conditions.

The monitoring software BeltBeat STC displays in a computer screen ECG waveforms and heart rate numerics, and may be configured to generate patient alarms and alert messages. Additionally, full recording of patient data is available. The software is capable of monitoring up to 12 patients (BeltBeat WF400 units) simultaneously.

BeltBeat system is intended for 5-lead ECG monitoring.

This 510(k) submission for the BeltBeat ECG monitoring system does not contain the detailed information necessary to complete the requested tables and descriptions regarding acceptance criteria and a study proving the device meets those criteria. The provided summary focuses on regulatory classifications, device description, indications for use, and substantial equivalence to predicate devices, but lacks specific performance data, study design details, or acceptance criteria.

Therefore, many sections below will state "Not provided in the document" or "Information not available."

Here's the summary based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not provided in the document. The submission mentions "Verification, Validation and Testing (VV&T) documents" but does not detail the specific tests conducted or the sample sizes of patients or data used.
• Data provenance: Not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not provided in the document.
• Qualifications of experts: Not provided in the document.

4. Adjudication method for the test set

• Adjudication method: Not provided in the document.

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 device is an ECG monitoring system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study would generally not be applicable in the context of improving human reader performance with AI assistance for interpreting images or complex data. The document does not describe any such study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The document describes the BeltBeat system as a "comprehensive ambulatory system solution for ECG monitoring" that "captures and transmits ECG signals that are then processed and displayed on the Information Center (BealtBeat STC)." It notes that the "Information Center generates alarms and recordings, thus notifying clinicians of changes in patients' conditions." This implies that the system processes and analyzes ECG signals to trigger alarms and display data. However, the document does not explicitly state or describe a standalone performance study of these algorithms with specific metrics (e.g., sensitivity/specificity of arrhythmia detection without clinician intervention). The focus is on the integrated system providing information to clinicians.

7. The type of ground truth used

• Type of ground truth: Not provided in the document. For an ECG monitor, ground truth would typically involve a verified "gold standard" ECG recording, possibly with expert annotation of events, or physiological measurements.

8. The sample size for the training set

• Sample size for training set: Not provided in the document. The submission references "Verification, Validation and Testing (VV&T) documents" but does not detail a training set for machine learning or algorithmic development. Given the 2009 submission date, advanced machine learning requiring large training sets may not have been the primary method for signal processing and alarm generation.

9. How the ground truth for the training set was established

• How ground truth was established: Not provided in the document.

Summary of Study Information based on Provided Document:

The 510(k) summary for the BeltBeat device (K083715) outlines its purpose as an ambulatory ECG monitoring system. It mentions that "All Verification, Validation and Testing (VV&T) documents - constitute a part of the device DMR and are available upon request." However, this summary itself does not contain any specific performance studies, acceptance criteria, or detailed data from such studies. It primarily focuses on defining the device, its intended use, principles of operation, and demonstrating substantial equivalence to pre-existing predicate devices (Welch Allyn Micropaq Monitor and Philips Transmitters M2601B + IntelliVue Information Center). The document lacks the detailed scientific or engineering study results that would typically include acceptance criteria, sample sizes, and ground truth methodologies.

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