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ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients:

1. suspected of cardiac abnormalities, or
2. in populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics are desired.
3. QT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacologic therapy. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization.
4. The PCECG-1200 System With MEANS has been tested to measure Heart Rate Variability within 1 millisecond tolerance. The clinical significance of HRV measures should be determined by a physician.
5. The PCECG-1200 System With MEANS has been tested to measure Late Potential within 1 millisecond tolerance in the time domain, and 1 microvolt tolerance in voltage. The clinical significance of Heart Rate Variability measures should be determined by a physician.

Stress testing intended use:
Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of a reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thereby coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients are exercised by bicycle, treadmill, or other means while continuously monitoring the ECG. Exercise loads are determined by predefined protocols. The ECG signals are recorded for the resting, exercise and recovery portions of the exercise protocol. The changes in ECG waveforms are compared to the resting ECG records. Although not necessary, most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol.

ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.

The PCECG-1200 System With Modular ECG Analysis System (MEANS) is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. The System comprises:

• · Data Acquisition Unit
• · RF transceiver
• · USB communications cable
• · Software application
• · Software access security lock (dongle), optional

The system acquires ECG data and displays it on the color monitor, calculates and controls some parameters of ECG display such as sweep speed, filters line interference and muscle noises introduced during monitoring, makes necessary outputs, handles the user interface, and controls the flow of operations.

Acquired data is stored, and subsequently transferred to the PC for display. Up to 12 channels of real time ECG display are possible. The available commands, calculation of results and status messages are also displayed. All commands are initiated via keyboard.

ECG is analyzed by the Modular ECG Analysis System (MEANS), which is a cleared O.E.M. SW Application obtained by Norav from the producer: the Department of Medical Informatics Erasmus University Medical Center Rotterdam, the Netherlands.

The provided document is a 510(k) Summary for the NORAV PCECG-1200 System with Modular ECG Analysis System (MEANS). It outlines the device's intended use, technological characteristics, and substantial equivalence to predicate devices. However, it does not contain the specific details about acceptance criteria or a dedicated study that proves the device meets those criteria in a way that directly maps to your requested table and study information.

Instead, the document makes general statements about testing and performance. It mentions:

• "The PCECG-1200 System With MEANS has been tested to measure Heart Rate Variability within 1 millisecond tolerance."
• "The PCECG-1200 System With MEANS has been tested to measure Late Potential within 1 millisecond tolerance in the time domain, and 1 microvolt tolerance in voltage."
• "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing."

These are statements about what was tested and the reported performance, but they lack the full context of "acceptance criteria" (i.e., the predefined thresholds that must be met for approval) and the detailed methodology of the studies.

Therefore, many of the requested fields cannot be extracted directly from this document.

Here's how I can address your request based on the available information, noting where data is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly suggests these tolerances are "acceptance criteria" because it states the device "has been tested to measure... within" these values. However, it does not explicitly define these as pre-established acceptance criteria that had to be met. For ST segment accuracy, no specific numerical criterion is provided, only that it was "tested for accuracy."

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

• Sample size: Not specified. The document only mentions that a "database has been used as a tool for performance testing" for the ST segment algorithm.
• Data provenance: Not specified for any of the performance claims.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Not specified.

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 MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in this document. The device is for automated ECG analysis.

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

• Yes, the performance claims strongly suggest standalone (algorithm-only) testing as the device is an "ECG Analysis System" intended for automated analysis. For example, "The PCECG-1200 System With MEANS has been tested to measure Heart Rate Variability..." implies testing the algorithm itself.

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

• Not explicitly stated. For Heart Rate Variability and Late Potential, the "tolerance" suggests a comparison against a highly accurate reference measurement or a gold standard method. For the "ST segment algorithm accuracy," it refers generally to a "database," but the nature of the ground truth within that database (e.g., expert annotations, confirmed diagnoses) is not detailed.

8. The sample size for the training set

• Not specified. The document states the MEANS software is a "cleared O.E.M. SW Application obtained by Norav from the producer: the Department of Medical Informatics Erasmus University Medical Center Rotterdam, the Netherlands." This implies the training (and development) was done by the OEM.

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

• Not specified. This information would typically reside with the original developer of the MEANS software, not necessarily in this 510(k) submission.

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