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The RhythmStar system is intended for use by 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 and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers all recorded cardiac activity to the cloud server where it is presented and can be retrospectively reviewed by a medical professional at a monitoring center. The RhythmStar system is not intended for real-time monitoring.

The data received from the RhythmStar device can be used for retrospective review, arrhythmia analysis, and further evaluation, reporting and signal measurements using RhythmStar system or a compatible arrhythmia analysis software that has been FDA cleared for Lead II analysis using nontraditional wet electrode placement. The RhythmStar system is not intended to sound any alarms.

The device does not deliver any therapy, administer any drugs, or provide for life support. The RhythmStar system does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician. RhythmStar is for prescription use only.

The RhythmStar system consists of the RhythmStar device and the server. The RhythmStar device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and autotriggered events such as Bradycardia, Tachycardia, and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is capable of automatically delivering the collected ECG data to the server using a built-in 4G LTE wireless data modem, or the data can be transferred from the device using a USB connection. The data transmitted by the RhythmStar device can be stored, evaluated, and presented for review, analysis and reporting by a medical professional using a server, such as the RhvthmStar Svstem server.

The provided document, an FDA 510(k) summary for the RhythmStar System (K233584), describes the device and its indications for use, but it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (RhythmStar System K141813 and Zio AT ECG Monitoring System K163512) by comparing intended use, indications for use, and technological characteristics. While it mentions various types of testing performed (Biocompatibility, Electrical Safety, EMC, Software V&V, Performance Testing, Cybersecurity), it does not present the acceptance criteria for these tests or the quantitative results of the device's performance against those criteria.

Specifically, the following information, crucial for addressing your request, is not available in the provided text:

• A table of acceptance criteria and reported device performance: This is the most significant missing piece. The document states that performance testing was done in accordance with ANSI/AAMI EC57 and that bench testing confirmed certain functionalities, but it does not quantify the performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection) or list the specific target acceptance values.
• Sample size used for the test set and data provenance: No information on the actual test dataset size, age group, or whether the data was retrospective or prospective.
• Number of experts used to establish ground truth and their qualifications: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device's primary function is to record and transmit data for retrospective review by a medical professional; it is not presented as an AI-assisted diagnostic tool for human readers itself.
• Standalone (algorithm only) performance: While an embedded arrhythmia detection algorithm is mentioned, its standalone performance metrics (e.g., accuracy for AFib detection) are not provided. The document states: "The RhythmStar system does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician." This suggests the algorithm's output is raw data or simple event flags, not a diagnostic interpretation.
• Type of ground truth used: Not specified, as no detailed performance study results are provided.
• Sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

Conclusion based on the provided text:

The document serves as a 510(k) summary, demonstrating the substantial equivalence of the RhythmStar System to existing legally marketed devices, primarily the RhythmStar RS-10002 (K141813). It asserts that the device is safe and effective based on various conformance tests to recognized standards (IEC, ANSI/AAMI, ISO) and bench testing, but it does not disclose the specific quantitative acceptance criteria or the numerical performance results that would fulfill your request for detailed proof of meeting acceptance criteria for its core functions (like arrhythmia detection accuracy).

To obtain the information you requested about device performance against acceptance criteria, one would typically need access to the full 510(k) submission, which contains the detailed testing reports and results.

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The RhythmStar system is intended for use by patients who cither 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 RhythmStar device can be used by another device for arrhythmia analysis, reporting and signal measurements. The RhythmStar system 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. RhythmStar is for prescription use only.

The RhythmStar system consists of the RhythmStar device and the server. The RhythmStar device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and auto-triggered events such as Bradycardia, Tachycardia, and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is capable to automatically deliver the data to the server. The data can be delivered to the server wirelessly via mobile network or via USB connection. A medical professional, using the server, can adjust and program the device configuration and auto-triggering parameters.

The provided text describes the RhythmStar System, a cardiac monitor. While it outlines extensive performance and safety testing against various IEC and ANSI/AAMI standards, it does not contain details about specific acceptance criteria for a device's performance (e.g., sensitivity, specificity for arrhythmia detection) or a study that specifically proves the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and general compliance with regulatory standards for medical electrical equipment. It emphasizes that the device functions as intended and meets design specifications.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document lists general performance and safety tests passed, but not specific performance metrics (e.g., detection accuracy for arrhythmias) with corresponding acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not provided. The document mentions "bench test results verify that RhythmStar system can continuously record ECG signal, store ECG data in the device memory, and transmit manual or auto activated event recordings to the server..." However, it does not detail a "test set" in the context of clinical data for performance evaluation (e.g., for arrhythmia detection accuracy). The performance tests described (IEC/ANSI standards) are typically bench or lab-based rather than involving patient data in a test set for diagnostic accuracy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/Not provided. Since no specific clinical test set for diagnostic performance is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document does not describe a MRMC study or any study comparing human reader performance with and without AI assistance. The RhythmStar system uses an embedded arrhythmia detection algorithm, but its interaction with human interpretation and any performance improvement metrics are not discussed.

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

Implied, but details are absent. The device has an "embedded arrhythmia detection algorithm" that auto-triggers events. "The data received from the RhythmStar device can be used by another device for arrhythmia analysis, reporting and signal measurements." This suggests standalone algorithm capability. However, no specific performance metrics (e.g., sensitivity, specificity, accuracy) for this algorithm are provided in the document. The statement "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" indicates the algorithm acts as a trigger, with subsequent review by a professional.

7. The Type of Ground Truth Used

Not explicitly stated for diagnostic performance. For the functional and safety tests, the "ground truth" would be the specifications and requirements of the standards themselves (e.g., electrical safety, EMC limits, usability requirements). If the "embedded arrhythmia detection algorithm" performance was evaluated, the type of ground truth (e.g., expert-adjudicated ECGs, pathology, clinical outcomes) is not mentioned.

8. The Sample Size for the Training Set

Not provided. The document does not discuss any machine learning model training or training set sizes for the embedded arrhythmia detection algorithm.

9. How the Ground Truth for the Training Set was Established

Not provided.

Summary of available information:

The document focuses on regulatory compliance and substantial equivalence to predicate devices, emphasizing that the RhythmStar System passes various electrical, safety, and performance standards relevant to ambulatory electrocardiographic systems. It details the device's technological characteristics and differences from predicates, stating these differences do not impact safety or effectiveness. However, it does not provide specific clinical performance metrics or studies directly demonstrating the accuracy of its arrhythmia detection algorithm against predefined acceptance criteria using clinical data. The "performance testing" section primarily references compliance with general medical device standards.

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