(98 days)
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.
§ 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).