(244 days)
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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.