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The Rhythm Express remote cardiac monitoring system is intended for use by patients greater than 10 kg 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 for review by a medical professional. The data received from the Rhythm Express device can be used by another compatible device for arrhythmia analysis, reporting and signal measurements. The Rhythm Express device is not intended to be used as part of an alarm system or for active patient monitoring.

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.

This device is not intended for patients in whom quantification of triplets/couplets is needed.

The RX-1 mini Rhythm Express Remote Cardiac Monitoring System (RCMS) is a multiple function device consisting of three components: 1) the RX-1 mini remote cardiac monitoring device ("RX-1 mini device") with on-board ECG waveform analysis algorithm, 2) the Web Service (RS-1) with server and database, and 3) back-office software (Operator Portal and Clinic Portal). The RS-1 server, Operator Portal, and Clinic Portal are non-device software functions.

The RX-1 mini device is worn by patients for a period of time as prescribed by a physician, up to 30 days, and continuously monitors ECG. The RX-1 mini device functions in one of three modes: a) Outpatient Cardiac Telemetry (OCT), b) Event Recorder (ER), and c) Wireless Holter monitor (WH). The device connects to standard ECG electrodes to capture 2 channel ECGs. The embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. The RX-1 mini device incorporates a cellular modem and Wi-Fi to communicate with the RS-1 Web Service.

The RX-1 mini device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements.

This FDA 510(k) clearance letter and summary does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets them.

The provided document primarily focuses on:

• Regulatory information: Clearance letter, product codes, classification, and applicable regulations.
• Device comparison: High-level overview of similarities and differences with the predicate device.
• General performance testing: A list of standards to which various tests were conducted (EMC, electrical safety, biocompatibility, software functionality, etc.), but not the specific results or acceptance criteria for those tests.
• Indications for Use: Clarification on the intended purpose of the device.

Crucially, it lacks the detailed information about the clinical study, including:

• Specific acceptance criteria for clinical performance: While it mentions "ECG algorithm performance," it doesn't state what metrics (e.g., sensitivity, specificity for arrhythmia detection) were used or what the target values were.
• Reported device performance values: There are no tables or explicit statements of the device's accuracy for detecting specific cardiac events.
• Test set details: No information on sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods for the clinical performance study.
• Training set details: No information on the training data size or how its ground truth was established.
• MRMC study: There's no mention of a human-in-the-loop study comparing human readers with and without AI assistance.
• Standalone performance: While it alludes to "ECG algorithm performance," it doesn't explicitly state the results of a standalone algorithm performance study.

Therefore, based solely on the provided text, I cannot create the table of acceptance criteria and reported performance, nor can I fully describe the study in the detail you requested.

The document states: "Performance testing verifies that the RX-1 mini Rhythm Express RCMS meets performance specifications." and "Performance testing data demonstrate that the subject device is as safe, and as effective, as the predicate device." This implies that such data exists and was submitted to the FDA, but it is not included in this public-facing summary.

To meet your request, one would typically need access to the full 510(k) submission, which would include detailed study reports, statistical analysis plans, and performance data.

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The Rhythm Express remote cardiac monitoring system is intended for use by patients greater than 10 kg 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 for review 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 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 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) Pre-market Notification for the RX-1 Rhythm Express Remote Cardiac Monitoring System. It does not contain a detailed study report with acceptance criteria and a comprehensive breakdown of device performance as one might find in a clinical trial summary.

However, based on the information provided, here's a summary of the performance testing and how it relates to general acceptance in regulatory submissions:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of explicit acceptance criteria and corresponding performance metrics for the device's accuracy in arrhythmia detection or analysis. Instead, it refers to successful completion of various performance and safety standards, and general functional verification.

• IEC 60601-1-1:2012 Ed. 3.1: Passed. (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 4th Edition: Passed. (Electromagnetic compatibility)
• IEC 60601-1-11:2015 Edition 1.1: Passed. (Requirements for home healthcare environment)
• ISO 10993-1: Biocompatibility testing of patient contacting materials passed. |
  | Software Life Cycle | - IEC 62304:2015 Ed. 1.1: Passed. (Medical Device Software Software Life Cycle Processes) |
  | Security Risk Management | - ANSI/AAMI TIR57:2015: Passed. (Principles for medical device security-Risk management) |
  | Usability | - IEC 62366-1:2015 Edition 1.0: Passed. (Application of usability engineering to medical devices) |
  | Wireless Coexistence | - ANSI IEEE C63.27-2017: Passed. (Evaluation of Wireless Coexistence) |
  | Functional Performance (Specific to Monitoring System) | - Bench test results verified: The 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.
• Conclusion: All requirements were met, and the RX-1 Monitor performs as designed. (Does not explicitly list quantitative performance metrics for arrhythmia detection accuracy, sensitivity, specificity, etc.) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses bench testing and compliance with standards. There is no mention of a clinical test set involving human subjects, nor any details about data provenance (country of origin, retrospective/prospective). The performance claims are based on engineering bench tests and adherence to recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since the testing primarily involved bench tests and compliance with standards, the concept of "ground truth" as established by medical experts for a clinical dataset is not applicable here. The "ground truth" for the functional tests would be the expected behavior of the device as per its design specifications.

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

Not applicable, as there's no mention of a clinical test set requiring expert adjudication.

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

No such study is mentioned or implied in the provided text. The device is referred to as an "ECG analysis algorithm" that detects arrhythmias, but its impact on human reader performance is not evaluated in this submission summary.

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

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." It also mentions that "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 for review by a medical professional."

This indicates that the algorithm performs standalone detection, and then the data is presented for human review. However, the submission does not provide specific performance metrics for this standalone algorithm (e.g., sensitivity, specificity, PPV for various arrhythmias). The "bench test results verify that RX-1 Monitor system can continuously record ECG signal... and transmit manual or auto activated event recordings to the server for evaluation by a medical professional" confirms the functional aspect of the algorithm's automatic detection and transmission.

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

For the functional bench tests, the "ground truth" would be the engineering specifications and expected signal characteristics. For instance, testing noise reduction or signal recording accuracy would compare the device's output against known input signals or precise measurement standards. There's no mention of medical ground truth (e.g., expert-annotated ECGs, pathology, or outcomes) used to validate the arrhythmia detection algorithm's accuracy.

8. The sample size for the training set

The document does not provide details about a training set for the embedded ECG analysis algorithm. It is a 510(k) submission focused on substantial equivalence to predicate devices and adherence to performance standards, rather than a detailed algorithm validation report.

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

Not applicable, as no information regarding a training set is provided.

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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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