Search Results

The ECG Holter evaluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter ECG recordings. The Holter recordings are used for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of dizziness or for controlling medical therapies, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic ischemias.

The ECG Holter evoluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter EOG recordings. The Holter iscoralings are used for the diagnostics of symptomatic and asymptomatic arrhythings, i.e. bradyeardia, tachycardia, diagnastic of arthythinias in pattents with coraniary artery disease, in cardiomopathy, high blood pressure, long QT syndrome, A Holter ECG recording is also used for clarifying palpitations or syncopes and attacks of aliziniess or for controlling medical theraples, or after operative treatments such as bypass operations or PTCA. The ST segment analysis of a Holter ECG is used for the detection of symptomatic or asymptomatic Ischemics. The software runs on Windows™ 95.

Here's a breakdown of the acceptance criteria and study information for the SCHILLER Microvit MT-200 Holter Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Arrhythmia Detection: The test set comprised "the AHA and MIT data bases." No specific number of records or patients is provided, but these are well-known, publicly available databases widely used for Holter ECG algorithm validation. The provenance is likely mixed, given the international nature of these databases, and typically retrospective, as they are pre-recorded and annotated datasets.
• ST-T Segment Analysis: The test set used "the ESC ST.T. database." Similar to the arrhythmia detection, no specific number of records is provided. This is also a well-known, typically retrospective database.

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

• Arrhythmia Detection: The ground truth for arrhythmia detection was established by "the annotations in the databases [AHA and MIT]." The number and qualifications of experts who created these annotations are not specified in this document. These databases are generally annotated by multiple expert cardiologists or electrophysiologists.
• ST-T Segment Analysis: The ground truth for ST-T analysis was established by "two independent observers." Their specific qualifications (e.g., "cardiologist with X years of experience") are not provided, only that they were "independent observers."

4. Adjudication Method for the Test Set

• Arrhythmia Detection & ST-T Segment Analysis: For arrhythmia detection, the MT-200's classifications were directly "compared with the annotated classifications of the data bases." For ST-T analysis, the MT-200's measurements were "compared to the deviations measured by two independent observers." This implies a direct comparison rather than an explicit arbitration or 2+1/3+1 adjudication method being used during the study. The ground truth itself, particularly for the well-established AHA/MIT/ESC databases, would have undergone rigorous expert consensus and adjudication during its creation.

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

• No MRMC comparative effectiveness study is mentioned. The study focuses on evaluating the algorithm's performance against established ground truth rather than assessing human reader improvement with AI assistance.

6. Standalone Performance

• Yes, a standalone performance study was conducted. The document explicitly states: "The classifications given by the MT-200 were then compared with the annotated classifications of the data bases," and for ST-T analysis, "The STsegment deviations measured by the MT-200 were compared to the deviations measured by two independent observers." This demonstrates the algorithm's performance without human intervention in the loop during the reported tests.

7. Type of Ground Truth Used

• Arrhythmia Detection: Expert consensus, as represented by "the annotated classifications in the AHA and MIT databases."
• ST-T Segment Analysis: Expert consensus, as determined by "two independent observers" measuring ST-segment deviations.

8. Sample Size for the Training Set

• The document does not provide any information about the sample size used for the training set. The study focuses solely on the evaluation of the device's performance using established test databases.

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

• Since no information on a training set is provided, there is no mention of how its ground truth would have been established. This K973751 focuses on the validation of the developed software using known benchmark databases.

Ask a specific question about this device