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The HearTwave II Cardiac Diagnostic System is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing.

The presence of Microvolt T-wave Alternans as measured by the HearTwave II Cardiac Diagnostic System in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The HearTwave II Cardiac Diagnostic System should be used only as an adjunct to clinical history and the results of other non-invasive and/or invasive tests. The interpretive results of the Alternans Processing System should be reviewed by a qualified physician.

The predictive value of T-wave Alternans for cardiac events has not been established in patients with active, untreated ischemia.

*Microvolt T-wave Alternans is defined as T-wave alternans which (a) is measured from high-resolution multi-segment sensors, (b) is present in leads X, Y, Z, VM or two adjacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the background noise level, (d) is at least three standard deviations greater than the background noise level, (e) has an onset heart rate at or below 110 beats per minute, and (f) is sustained for all heart rates above the onset heart rate.

The Cambridge Heart HearTwave II Cardiac Diagnostic System is intended for the measurement and recording of T-Wave alternans. The alternans levels reported in K983012, K001034, K003492 and K022149 were measured using the Analytic Spectral Method. This method consists of several computational steps that combine to form a unique analytical process. The Microvolt T-wave Alternans measurement, the output of this specific process, has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.

The Cambridge Heart HearTwave II Cardiac Diagnostic System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of Alternans Processing used in the Cambridge Heart HearTwave II is intended for the measurement of microvolt T-Wave alternans at rest and during treadmill, ergometer and pharmacologic stress testing.

The Alternans test using the Cambridge Heart HearTwave II is performed with seven standard stress test electrodes and seven proprietary multi-segment Micro-V Alternans™ Sensors. The electrodes and sensors are attached through a leadwire set to the beltworn Patient module, which provides digitized data to the HearTwave II.

The provided document does not contain explicit acceptance criteria or a study proving the device meets specific performance criteria beyond general performance standards. This 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (K022149, the HearTwave II Cardiac Diagnostic System) for a modification, rather than detailing a new performance study with acceptance criteria.

The document indicates that the HearTwave II Cardiac Diagnostic System uses the same Analytic Spectral Method as the predicate device (CH2000, K022149) for measuring T-Wave Alternans. Therefore, the performance characteristics are presumed to be largely similar to the predicate.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• No explicit acceptance criteria (e.g., specific sensitivity, specificity, accuracy targets) are provided in this document. The submission focuses on compliance with general performance standards for medical electrical equipment and ECG devices.
• No specific device performance metrics (e.g., sensitivity, specificity, PPV, NPV) are reported for this specific 510(k) submission. The document states "The Microvolt T-wave Alternans measurement, the output of this specific process, has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death," but does not provide new performance data to support this for the modified device. It likely refers to studies done on prior versions of the system.

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

• Not specified. The document does not describe a new test set or data used for an independent performance evaluation for this 510(k) submission.

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

• Not applicable/Not specified. Since no new performance study with a test set is detailed, information about experts for ground truth is not provided.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. As no new performance study is detailed, no adjudication method is mentioned.

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

• No. The document does not describe an MRMC study or any assessment of human-AI collaboration for this submission. The device appears to be an analytical tool, not primarily an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone (Algorithm Only) Performance Study:

• Implied, but no new study is reported in this document. The "Analytic Spectral Method" is an algorithm. The 510(k) states: "The HearTwave II Cardiac Diagnostic System uses the same Analytic Spectral Method as the CH2000 (K02149) for measuring T-Wave Alternans." This suggests the standalone performance was established for the predicate device, but no new standalone study specific to this K050225 modification is detailed.

7. Type of Ground Truth Used:

• Not specified for this submission. For the predicate device's original validation of its predictive value, the ground truth would likely have been clinical outcomes data (e.g., confirmed ventricular tachyarrhythmia or sudden cardiac death). However, this document does not detail how ground truth was established for the claims made.

8. Sample Size for the Training Set:

• Not specified. The document does not mention any training sets for machine learning models as it describes a specific "Analytic Spectral Method" rather than a trained AI model in the contemporary sense. If the "Analytic Spectral Method" has tunable parameters, how those parameters were determined (e.g., "signal optimization," "subtraction of the background noise level") would be relevant, but this information is not provided.

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

• Not applicable/Not specified.

Summary of what is present in the document:

• Indications for Use: The system records ECGs, vector cardiograms, and measures Microvolt T-Wave Alternans at rest and during stress testing. The presence of Microvolt T-wave Alternans (as defined by specific criteria) predicts increased risk of cardiac events in specific patient populations.
• Definition of Microvolt T-wave Alternans: This is a crucial "acceptance criteria" for the measurement itself, detailing conditions like amplitude (1.9 microvolts after signal optimization), statistical significance (three standard deviations above noise), and heart rate conditions. This is a definition of a positive finding by the device, not an acceptance criterion for the device's overall performance (e.g., accuracy against a clinical outcome).
• Device Description: It uses an "Analytic Spectral Method" for T-wave alternans processing, which is stated to be the same as the predicate device.
• Performance Standards: The device is designed to meet various national and international safety and electrical performance standards (e.g., ANSI/AAMI EC11-1991, EN60601 series, IEC 60601 series, FDA guidances). These are engineering standards, not clinical performance metrics.
• Substantial Equivalence: The primary assertion of the 510(k) is that the modified HearTwave II Cardiac Diagnostic System is "essentially the same device" as the predicate (K022149) with respect to the T-wave Alternans measurement method. This implies that the performance characteristics of the predicate are sufficient and apply to the modified device.

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