(191 days)
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 events, 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.
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 subject ZEUS System utilizes an artificial intelligence (AI) Al-based AutoTrigger Engine (ATE) software application for processing requests originating from the Gateway Service as part of the Zio AT system enabling asymptomatic ECG triggers, and Al-based ECG Analysis Software (ECGDL) to generate the initial ECG-based cardiac information.
The output of ECG Analysis Software of the ZEUS System is used by Certified Cardiographic Technicians (CCTs) prior to publishing the cardiac information in the patient 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.
The subject of this 510(k) are proposed software modifications to the ZEUS System to allow AF/AFL burden estimate reporting in the daily reports. In addition, software modifications were made to the ECGDL software of the ZEUS System to target modest performance improvements.
The ZEUS System, subject of K222389, is substantially equivalent to its predicate device (K202527), based on non-clinical performance data. Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance
The provided document refers to non-clinical verification and performance testing that established the device meets its design requirements. However, it does not explicitly list specific acceptance criteria thresholds (e.g., sensitivity, specificity, accuracy targets) for arrhythmia detection or AF burden estimation, nor does it provide a table of reported device performance against such specific criteria.
Instead, it states: "The nonclinical verification and performance test results established that the device meets its design requirements and intended use, that the design differences with the cleared device do not raise new questions of safety and efficacy." And, "The verification and validation testing demonstrate that the device meets all predetermined specifications."
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 does not provide details on the sample size used for the test set in terms of the number of ECG recordings or patients, nor does it specify the data provenance (country of origin, retrospective/prospective). It only mentions "nonclinical verification and performance test results."
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)
The document states that the output of the ECG Analysis Software is "quality reviewed by CCTs" (Certified Cardiographic Technicians) before publishing the report. However, it does not specify:
- The number of CCTs or other experts involved in establishing ground truth for the test set used in the non-clinical performance evaluation.
- The specific qualifications or experience levels of these CCTs or any other experts who might have been involved in a ground truth process for testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. It mentions CCTs perform a "quality review," but the procedure for resolving discrepancies or establishing a "ground truth" for formal testing purposes is not detailed.
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 MRMC comparative effectiveness study is mentioned in the provided text. The document explicitly states: "No clinical testing was performed in support of this premarket notification." The system's output is intended for review by clinicians, but the document does not describe any studies on the impact of the AI on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance of the algorithm is implied for the "ECGDL software of the ZEUS System to target modest performance improvements" and the "Al-based AutoTrigger Engine (ATE) software application." The non-clinical performance testing would evaluate the algorithm's output prior to human review, to ensure it meets design specifications. However, specific standalone performance metrics (e.g., sensitivity, specificity for various arrhythmias) are not provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document indicates that "the output of ECG Analysis Software of the ZEUS System is used by Certified Cardiographic Technicians (CCTs) prior to publishing the cardiac information in the patient report." This strongly suggests that for the operational process, the ground truth is essentially expert consensus/review by CCTs. For the non-clinical performance testing, it is implied that a similar expert review or a reference standard based on expert interpretation of ECG data would be used to establish ground truth, but this is not explicitly detailed.
8. The sample size for the training set
The document does not provide any information regarding the sample size used for the training set of the AI-based AutoTrigger Engine (ATE) and ECGDL software.
9. How the ground truth for the training set was established
The document does not specify how the ground truth for the training set was established. It describes the general function of the system and its review process by CCTs, but details concerning training data annotation are absent.
§ 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).