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The Rhythm Express remote cardiac monitoring system is intended for use by adult patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional.

The data received from the Rhythm Express device can be used by another device for arrhythmia analysis, reporting and signal measurements. The Rhythm Express device is not intended to sound any alarms.

The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The Rhythm Express system communicates events from the patient to the monitoring center within one to seven minutes (assuming cell service is available) and hence is not suitable for use as a real-time arrhythmia event monitor.

The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 device uses an embedded cellular modem on the Verizon LTE network.

The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

The provided text is a 510(k) Summary for the VivaQuant Inc. RX-1 Rhythm Express Remote Cardiac Monitoring System. It outlines the device's indications for use, comparison with a predicate device, and a summary of performance testing. However, it does not include specific acceptance criteria for the device features, nor does it detail a study that defines these criteria and reports the device's performance against them in a quantitative way (e.g., sensitivity, specificity, accuracy for arrhythmia detection).

The document mentions "Bench test results verify that RX-1 Monitor system can continuously record ECG signal, store ECG data in the device memory, and transmit manual or auto activated event recordings to the server via mobile network connection for evaluation by a medical professional. Test results verify that all requirements were met and that the RX-1 Monitor performs as designed." However, these are general statements and do not provide the detailed information requested regarding specific acceptance criteria and performance metrics for the device's core functionality (e.g., arrhythmia detection accuracy).

Therefore, I cannot fully answer your request based on the provided text.

Here's a breakdown of what can and cannot be extracted from the document:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided. The document states that "Test results verify that all requirements were met and that the RX-1 Monitor performs as designed," but it does not specify what those requirements (acceptance criteria) are in a measurable way (e.g., a specific sensitivity or specificity for detecting an arrhythmia type). It also does not present numerical performance results against such criteria.

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

• Cannot be provided. The document mentions "Bench test results" but does not specify any sample sizes (e.g., number of ECG recordings, duration of recordings) or the provenance (country of origin, retrospective/prospective) of any data used for testing the device's analytical capabilities. The testing listed focuses on electrical safety, EMC, usability, and biocompatibility.

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

• Cannot be provided. There is no mention of an expert panel or their qualifications for establishing ground truth for any performance evaluation in the provided summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. No adjudication method is described, as there's no detailed mention of a test set where adjudication would be applicable specifically for algorithm performance.

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:

• Cannot be provided. The document does not describe any MRMC study or any study evaluating the improvement of human readers with AI assistance. The device is described as capturing and transmitting data for review by a medical professional, implying human-in-the-loop, but no comparative effectiveness data is presented.

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

• Cannot be directly confirmed with metrics. The document states "An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology." This indicates a standalone algorithmic function. However, no performance metrics (e.g., sensitivity, specificity, accuracy) for this standalone algorithm's detection capabilities are provided. The only statement is that "Test results verify that all requirements were met and that the RX-1 Monitor performs as designed," which is not specific enough.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Cannot be provided. Since no specific performance study with metrics is detailed for the arrhythmia detection algorithm, the type of ground truth used is not mentioned.

8. The sample size for the training set:

• Cannot be provided. There is no information in the document about a training set or its sample size.

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

• Cannot be provided. There is no information about how ground truth was established for a training set.

In summary, the provided 510(k) Summary focuses on substantial equivalence to a predicate device and general safety/performance testing (electrical, EMC, usability, biocompatibility) rather than detailed algorithmic performance for arrhythmia detection with specific acceptance criteria and study results.

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