Zio ECG Utilization Software (ZEUS) System

• K Number: K202527
• Device Name: Zio ECG Utilization Software (ZEUS) System
• Manufacturer: iRhythm Technologies, Inc.
• Date Cleared: 2021-05-21 ( 262 days)
• Product Code: DQK , DSI , DXH
• Regulation Number: 870.1425
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K190593

Intended Use

The device is intended to capture, and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring. After wear, ECG data from compatible monitoring devices is processed and analyzed by the ZEUS System. A final report is generated on the beat-to-beat information from the entire ECG recording. For the Zio AT service, the ZEUS System supports the capture and analysis of automatically-detected arrhythmia event, as well as the analysis of uploaded patient-triggered events.

The ZEUS System is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety and patients who are asymptomatic. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.

Device Description

The Zio® Service consists of single-patient-use monitoring devices and the Zio ECG Utilization Software (ZEUS) System, the subject device of this submission, for analysis and reporting of cardiac information derived from ECG data. The ZEUS System is a software system consisting of a collection of software modules designed to store and analyze data from compatible cardiac monitoring devices to curate a report of preliminary findings intended for use by clinicians as an aid in arrhythmia diagnosis and management. The ECG Analysis Software of the ZEUS System is used by Certified Cardiographic Technicians (CCTs) prior to publishing the reported cardiac information in the Final Report and is not utilized directly by the prescribing clinician or patient. The reported cardiac information includes beats, ectopic runs, ECG segments, rhythms, and heart rate measurements. Recorded ECG is processed by an automated ECG analysis platform; results are quality reviewed by CCTs, findings and associated ECG are captured in a report provided to clinicians via a secure website. For the Zio® AT Patch/Gateway, the ZEUS System provides capabilities to automatically detect clinically actionable arrhythmia during the monitoring period, as well as receive baseline, scheduled, symptomatic and asymptomatic transmissions.

AI/ML Overview

This FDA 510(k) summary for the Zio ECG Utilization Software (ZEUS) System (K202527) does not provide the detailed acceptance criteria and the comprehensive study results typically found in performance studies for AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K190593) primarily through non-clinical testing and comparison of technological characteristics.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not explicitly stated within this document. The document explicitly states: "No clinical testing was performed in support of this premarket notification."

However, I can extract the available information and highlight what is missing based on your request.

Summary of Available Information and Missing Details:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a table format within the document. The document states that "nonclinical verification and performance test results established that the device meets its design requirements and intended use." It also mentions "design specifications" which would contain acceptance criteria, but these are not enumerated. The "reported device performance" is not quantified in terms of metrics like sensitivity, specificity, or F1-score for arrhythmia detection.

2. Sample Size Used for the Test Set and Data Provenance: Not specified. The document only mentions "nonclinical testing" and "verification and system-level regression testing." It does not detail specific test sets for performance evaluation in terms of ECG data or patient population, nor does it mention data provenance (country, retrospective/prospective). Given that no clinical testing was performed, any "test set" would likely refer to internal validation data, which is not described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not specified. Since no clinical testing was performed and no specific test set based on expert-labeled data is described, this information is not present. The document mentions that "results are quality reviewed by CCTs" (Certified Cardiographic Technicians) as part of the overall Zio Service operation, but this refers to the workflow, not the establishment of ground truth for a predefined test set used for regulatory submission.

4. Adjudication Method: Not specified. No clinical study or expert-based ground truth establishment is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size: No. The document explicitly states, "No clinical testing was performed in support of this premarket notification." Therefore, no MRMC study was conducted or reported here.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done: The document describes the ZEUS System as a "software system consisting of a collection of software modules designed to store and analyze data... to curate a report of preliminary findings intended for use by clinicians... The ECG Analysis Software of the ZEUS System is used by Certified Cardiographic Technicians (CCTs) prior to publishing the reported cardiac information in the Final Report." This indicates a human-in-the-loop system where the algorithm's output is reviewed by CCTs. The document does not provide standalone performance metrics for the algorithm prior to CCT review.

7. The Type of Ground Truth Used: Not specified. Given the lack of clinical testing and detailed performance evaluation, the method for establishing ground truth for any internal validation is not described.

8. The Sample Size for the Training Set: Not specified. The document does not describe the development or training of any AI/ML components in detail, nor does it specify the size of any training data used. It only mentions "ECGDL" (ECG Deep Learning?) as the rhythm detection algorithm, replacing "ECGML + ECGDL" from the predicate.

9. How the Ground Truth for the Training Set was Established: Not specified.

Available Information from the Document:

While the direct answers to your questions are largely "not specified" due to the nature of this 510(k) submission focusing on substantial equivalence based on non-clinical testing, here's what the document does provide:

• Device: Zio ECG Utilization Software (ZEUS) System (K202527)
• Intended Use: "capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring." Reports are "provided for review by the intended user to render a diagnosis based on clinical judgment and experience."
• Predicate Device: iRhythm Technologies, Inc. Zio® ECG Utilization Software (ZEUS) System (K190593).
• Technological Change: The subject device introduces "ECG segment detection" (specifically QT interval detection) and uses "ECGDL" for rhythm detection, whereas the predicate used "ECGML + ECGDL." It also expands interoperability to include the Zio® Monitor.
• Performance Evaluation Method: "Safety and performance... has been evaluated and verified in accordance with design specifications and to support a determination of substantial equivalence... Nonclinical testing summarized in Table 2 demonstrates that the ZEUS System is in conformance with FDA-recognized consensus standards and FDA guidance documents."
• Standards/Guidance Documents Used for Nonclinical Testing:
  • AAMI ANSI ISO 14971:2012(R)2010 (Risk Management)
  • IEC 62304 Edition 1.1 2015-06 (Medical device software - Software life cycle processes)
  • AAMI ANSI IEC 60601-2-47:2012 (Ambulatory Electrocardiographic Systems)
  • AAMI ANSI EC57:2012 (Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms)
  • U.S. FDA October 2, 2014 Guidance (Cybersecurity in Medical Devices)
  • U.S. FDA May 5, 2005 Guidance (Software Contained in Medical Devices)
• Conclusion of Performance: "The nonclinical verification and performance test results established that the device meets its design requirements and intended use... The verification and system-level regression testing demonstrate that the device meets all its specifications."

In essence, this 510(k) clears the device based on demonstrating that its changes from the predicate device do not raise new questions of safety or effectiveness, supported by non-clinical engineering and software validation testing, rather than a clinical performance study with detailed acceptance criteria for diagnostic accuracy metrics.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).