(169 days)
The Zio ECG Utilization Service (ZEUS) System is intended to analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring by Zio XT or Zio AT Patch, a final report is generated based on the beat information from the entire ECG recording. It 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 ZEUS System is an electrocardiogram (ECG) processing and analysis system, designed to handle continuously recorded, single-lead ECG data. It downloads, stores, analyzes and aggregates the ECG data for a Certified Cardiographic Technician (CCT) to review and generate a report of the findings contained within the data; thereby enabling the provision of a complete ECG processing and analysis service.
The provided text is a truncated 510(k) submission summary for the Zio® ECG Utilization Service (ZEUS) System. Unfortunately, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the specific study that proves the device meets those criteria.
Specifically, the document states: "Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns." However, it does not present the specific acceptance criteria (e.g., target sensitivity/predictivity values) nor does it provide a table of acceptance criteria alongside reported device performance. It also explicitly states, "No clinical testing was performed in support of this premarket notification." Therefore, the detailed study information you requested (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance details, training set info) is not present in this document.
Based on the available text, here's what can be extracted:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): The device was expected to demonstrate sensitivity and positive predictivity levels that "satisfy requirements and minimize safety or efficacy concerns" for "any claimed analysis metrics."
- Reported Device Performance: The document states, "The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements..." However, no specific numerical values or a table comparing criteria to performance are provided.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document.
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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):
- This information is not provided in the document. The text mentions that a "Certified Cardiographic Technician (CCT) to review and generate a report of the findings contained within the data," but this refers to the intended use of the device for clinical review, not the establishment of ground truth for a performance study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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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, an MRMC comparative effectiveness study is not mentioned or implied. The document explicitly states, "No clinical testing was performed in support of this premarket notification."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document states, "Automated ECG analysis performance was quantified for any claimed analysis metrics." This suggests standalone algorithm performance was evaluated, but the results and methodology are not detailed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This information is not explicitly provided. Given the nature of ECG analysis, it would typically be expert annotation/consensus, but the document does not confirm this.
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The sample size for the training set:
- This information is not provided in the document.
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How the ground truth for the training set was established:
- This information is not provided in the document.
Summary of available information regarding performance evaluation:
- Device Name: Zio® ECG Utilization Service (ZEUS) System
- Purpose of Evaluation (Implied): To quantify automated ECG analysis performance for claimed metrics, demonstrating sensitivity and positive predictivity.
- Type of Testing: "Automated ECG analysis performance was quantified." This was part of "Overall system performance testing" and "Software verification testing" as "nonclinical testing."
- Result (General): "The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns."
- Lack of Detail: The document explicitly states "No clinical testing was performed" and does not provide specific numerical results, acceptance thresholds, sample sizes, methodology for ground truth, or details of expert involvement in performance studies.
§ 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).