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The CH 2000 is intended for the measurement of T-wave alternans and recording of electrocardiograms and vector cardiograms at rest and during ECG stress testing. The presence of T-wave alternans in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The CH 2000 should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests.

The Cambridge Heart CH 2000 Cardiac Diagnostic System is a computer-based ECG exercise tolerance test system designed for use in hospitals, offices and clinical cardiology laboratories.

The CH 2000 incorporates the following features:

• Recording of electrocardiograms and vector cardiograms with high-. resolution laser printer or thermal recorder output.
• Measurement of T-wave alternans. .
• Controlling resting and exercise stages of treadmill and bicycle ergometer ● stress tests based on standard and user-customized protocols.
• . Computation of ST-level and slope, plus supplemental measurements including ST-integral and ST-index.
• Diagnostic-quality color CRT display on a swivel-tilt mounting.
• Baseline and artifact filters to remove artifact without ST-seqment distortion. ●
• Detection of pacemaker functioning and visible pacemaker spikes displayed . on the ECG.

The provided text describes the Cambridge Heart CH 2000 Cardiac Diagnostic System and its substantial equivalence to other devices, primarily for the measurement of T-wave alternans. However, the document does NOT contain information about acceptance criteria or a dedicated study with performance metrics in the format requested.

The document discusses:

• Intended Use and Indications For Use: The CH 2000 is for T-wave alternans measurement and ECG/vector cardiogram recording at rest and during stress testing. It predicts increased risk of cardiac events in patients with known, suspected, or at risk of ventricular tachyarrhythmia, and should be used as an adjunct.
• Device Description and Principles of Operation: Details hardware components, software functions (QRS detection, heart rate, ST-T computations, T-wave alternans using Spectral Method), and signal acquisition.
• Comparison to Equivalent Devices: It explicitly states that the "comparison table... clearly illustrates that the systems are very similar regarding intended use, physical characteristics, target population, and safety characteristics." This comparison is the basis for the "Substantially Equivalent Determination" rather than a new standalone study with specific performance metrics for the CH 2000.

Therefore, I cannot populate the requested table and answer the study-specific questions. The document focuses on demonstrating substantial equivalence to previously cleared devices (Cambridge Heart Model CH 2000 K981697 and Zymed Model 2010 Holter Scanner K955015) rather than presenting a new study with acceptance criteria and measured performance for this specific submission (K983102).

Missing Information:

The document lacks the following crucial details to answer the prompt:

1. Acceptance Criteria for the CH 2000 (K983102): No specific performance targets (e.g., sensitivity, specificity, accuracy, precision for T-wave alternans detection) are stated.
2. Reported Device Performance: No quantitative results from a specific clinical study (e.g., accuracy metrics for T-wave alternans detection, comparison against a gold standard).
3. Sample Size for Test Set: No information on the number of patients/cases used in a performance evaluation.
4. Data Provenance for Test Set: No details on country of origin, retrospective/prospective nature.
5. Number of Experts for Ground Truth: Not mentioned.
6. Qualifications of Experts: Not mentioned.
7. Adjudication Method: Not mentioned.
8. MRMC Comparative Effectiveness Study: Not mentioned as being performed.
9. Standalone Performance Study: The document describes the system and its functions but does not present a standalone performance study with metrics against a ground truth. The basis for clearance appears to be substantial equivalence.
10. Type of Ground Truth: Not specified for any performance evaluation.
11. Sample Size for Training Set: Not applicable as no new algorithm training study is described.
12. Ground Truth for Training Set: Not applicable.

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