(156 days)
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.
| Acceptance Criteria Category (Inferred from regulatory standards) | Reported Device Performance |
|---|---|
| General Safety and Performance | - IEC 60601-2-47:2012: Passed. (Particular requirements for basic safety and essential performance of ambulatory electrocardiographic systems) |
- 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.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).