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The ZEUS System is intended for use by qualified medical professionals for the assessment ambulatory electrocardiogram (ECG) data from adult patients 18 years or older. The system is intended to be marketed as a service that downloads and analyzes up to 14 days of ECG data. Analysis metrics are provided in a report which is available for clinician review and printing. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.

The ZIO ECG Utilization Service System ("ZEUS System") is an electrocardiogram (ECG) processing and analysis system, designed to handle continuously recorded, single-lead ECG data. Once the ECG data is downloaded, the data is processed through the algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy. iRhythm trained Patch in-take and CCT personnel follow internal procedures for processing and are of the algorithm performance anomalies. Any software anomalies are visible to and manually corrected by iRhythm Technologies CCT's during the QA review and/or Patch Report edits. The CCT generates a final report of the ECG findings contained within the data; thereby enabling the provision of a complete ECG processing and analysis service.

The provided text describes the ZEUS (ZIO ECG Utilization Services) System, a programmable diagnostic computer for ambulatory ECG data analysis. It details the device's indications for use, product description, and claims of substantial equivalence to a predicate device. However, it does not provide specific details about acceptance criteria, reported device performance metrics in a table, sample sizes for test/training sets, ground truth establishment methods in detail, or information regarding multi-reader multi-case studies.

Based on the provided document, here's what can be extracted and what information is missing:

1. Table of acceptance criteria and the reported device performance:

Missing Information: Specific numerical acceptance criteria (e.g., sensitivity > X%, specificity > Y%) and the actual reported numerical performance of the device against these metrics.

2. Sample size used for the test set and the data provenance:

Missing Information: The document states "Automated ECG analysis performance was quantified for any claimed analysis metrics," but does not provide the sample size of the test set used for this quantification. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Missing Information: The document states that the output of the algorithm is delivered to a "QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy." It also mentions "iRhythm trained Patch in-take and CCT personnel follow internal procedures for processing and are of the algorithm performance anomalies." However, it does not specify the number of experts (CCTs or other medical professionals) used to establish ground truth for a test set, nor their specific qualifications (e.g., years of experience beyond "Certified Cardiographic Technicians"). It also doesn't explicitly state that these CCTs established the ground truth for a separate test set, but rather that they review and adjust algorithm output in the operational workflow.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Missing Information: The document mentions that CCTs review and adjust results, implying a human-in-the-loop process. However, it does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth on a specific test set for performance evaluation.

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:

Missing Information: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. The system's output is intended for review by a clinician, but no study is described to quantify improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document implies a system that includes human review: "Once the ECG data is downloaded, the data is processed through the algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy." And "Any software anomalies are visible to and manually corrected by iRhythm Technologies CCT's during the QA review and/or Patch Report edits." While the "Automated ECG analysis performance was quantified," the provided text does not explicitly state if a standalone algorithm-only performance evaluation was conducted entirely separate from this human-in-the-loop review process for regulatory submission. It seems the described system always includes human review as part of the service.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth appears to be established by Certified Cardiographic Technicians (CCTs) who review and adjust the algorithm's output. The document states: "the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy." This suggests expert review/adjudication as the basis for accuracy.

8. The sample size for the training set:

Missing Information: The document does not provide any information regarding the sample size used for training the algorithm.

9. How the ground truth for the training set was established:

Missing Information: The document does not describe how ground truth was established for the training set. It only mentions how "accuracy" for the analysis is handled, which seems to describe the operational workflow rather than a specific ground truth generation process for a dataset.

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The ZEUS System is intended for use by qualified medical professionals for assessment of a patient's recorded ambulatory ECG data. The system is intended to be marketed as a service that downloads and analyzes up to 14 days of ECG data. Analysis metrics are provided in a report which is available for clinician review and printing. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.

The ZEUS System is a software system designed to be used internally at IRhythm to provide a complete ECG processing and analysis service It includes software that enables ECG data download automated ECG analysis automated report generation and report delivery via a website It is capable of automated ECG analysis on continuously recorded singlelead ECG data up to 14 days in duration

The provided document describes the Zio ECG Utilization Service System (ZEUS System), manufactured by iRhythm Technologies Inc. It details the system's purpose, intended use, and its substantial equivalence to predicate devices, along with performance testing conducted to support its claims.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Minimum performance standards were developed internally at iRhythm in consultation with our clinical team and are documented in Section 13 of this submission." However, Section 13 is not included in the provided text. Therefore, a complete table of specific acceptance criteria and detailed reported performance metrics is not available in the provided document. The document only generally states: "The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns."

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

The document does not explicitly state the sample size used for the test set in the provided sections. It mentions "Extensive performance testing was conducted on the automated analysis algorithm portions of the ZEUS system" and a "study that compared analysis reports for a 48-hour continuous ECG recording." However, the number of records or patients in these tests is not quantified.

The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. It mentions that "Minimum performance standards were developed internally at iRhythm in consultation with our clinical team," implying clinical input on performance targets, but not specifically on ground truth adjudication for the test data.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done to assess human reader improvement with or without AI assistance. The ZEUS system's analysis is intended for review by a clinician to render a diagnosis. The comparison mentioned is between the ZEUS system's automated analysis and predicate systems, and with a "48-hour continuous ECG recording" for the Rozinn Holter Plus System, but not human performance with AI.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study of the algorithm was done. The document states: "Extensive performance testing was conducted on the automated analysis algorithm portions of the ZEUS system to ensure that automated performance was substantially equivalent to the Monebo automated analysis metrics." This indicates that the algorithm's performance was evaluated independently.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, given that the performance testing aimed to demonstrate substantial equivalence to the "Monebo automated analysis metrics" and involved comparing analysis reports, it is highly likely that the ground truth was established through expert review or consensus of ECG recordings, potentially referencing verified annotations from established databases or manual expert annotations.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It focuses on the evaluation of the algorithm's performance rather than its development details.

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

The document does not provide information on how the ground truth for the training set was established.

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