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The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardiographs 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 device, MICROVIT MT-100, is a recording device used to record long term Electrocardlographs for 24 hours, on two channels.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what's available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Braemar DL 700 Holter Monitor K945130) by meeting recognized standards. The "acceptance criteria" are implied by adherence to these standards and the comparison table.

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

• Sample Size: The document does not specify a "test set" in terms of patient data for clinical evaluation. The testing described is primarily non-clinical, involving the device itself against engineering standards.
• Data Provenance: Not applicable for patient data. The "tests" were conducted in a lab setting to verify device compliance with standards.

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

Not applicable. This was a non-clinical, engineering-centric evaluation against established standards, not a clinical study involving ground truth established by medical experts on patient data.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process on patient data is described. The tests were objective measurements against predefined standards.

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, an MRMC comparative effectiveness study was not done. The device is a Holter recorder, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device is a recording device. Its performance is evaluated based on its ability to accurately record and transmit ECG signals, not as an algorithm performing a diagnostic task. The "standalone" performance is implied by the successful completion of the electrical, environmental, and EMC tests against established medical device standards.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the established engineering and medical device standards (e.g., ANSI/AAMI EC 38-1994, IEC 601-1, MIL-STD-81D, IEC 801 series, EN 55011). The device's performance was compared against the requirements specified in these standards and the performance characteristics of the predicate device.

8. The Sample Size for the Training Set

Not applicable. The device is a physical recorder and does not utilize a "training set" in the context of machine learning or AI algorithms.

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

Not applicable, as no training set was used.

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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.

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The Cardiovit CS-200 device maybe used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program.

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The provided document is a 510(k) premarket notification letter from the FDA for a device called "Cardiovit CS-200". It states that the device can record and store standard 12-lead Electrocardiograms (ECG) at rest or during exercise. It also mentions that "Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program."

However, the document does not include the detailed information required to fill out a table of acceptance criteria and a study that proves the device meets those criteria. Specifically, the document is a regulatory clearance letter, not a study report or a detailed technical specification.

Therefore, I cannot provide the requested information from the given text.

Here's a breakdown of why this information is missing:

• Acceptance Criteria and Reported Device Performance: While the document states the device's function (ECG recording, storage, and interpretation), it does not specify any performance metrics (e.g., sensitivity, specificity, accuracy for specific ECG interpretations) or the quantifiable acceptance criteria for these metrics.
• Sample size and data provenance: No details about a test set, its size, or origin are provided.
• Number and qualifications of experts for ground truth: This information is not present.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study: There's no indication of any study comparing human readers with and without AI assistance.
• Standalone performance: While it mentions "automatically measured and interpreted," it doesn't provide performance data for this standalone function.
• Type of ground truth: Not specified.
• Sample size for training set: Not mentioned.
• How ground truth for training set was established: Not mentioned.

To answer your request, a more detailed technical submission, clinical study report, or a publication describing the validation of the Schiller ECG interpretation program would be needed.

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