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The Heartwave™ Alternans Processing System is intended for the measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing.

The presence of Microvolt T-wave Alternans as measured by the Analytic Spectral Method of the Heartwave™ Alternans Processing 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™ Alternans Processing 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 Heartwave™ Alternans Processing System is intended for the measurement and recording of T-Wave alternans. The modification which is the subject of this pre-market submission is the modification of a parameter in Alternans Report Classifier software which was cleared for marketing on November 17, 2002 (K03564). Classification software provides the clinician with an indication of positive, negative, or indeterminate result for the Alternans Trend Reports. The results remain subject to the final review of a qualified medical practitioner. The Microvolt T-wave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.

The Heartwave™ Alternans Processing System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of Alternans Processing used in the Heartwave is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and pharmacologic stress testing. The Alternans Report Classifier provides input to the physician on interpreting the Alternans trend reports.

The alternans test using the Analytic Spectral Method of Alternans Processing 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 belt-worn patient module, which provides digitized data to the Alternans Processor.

This 510(k) submission describes a modification to the Heartwave™ Alternans Processing System, specifically to its Alternans Report Classifier software. The document asserts substantial equivalence to a previously cleared device (K013564) rather than presenting a de novo study with explicit acceptance criteria and performance data for the modified classifier.

Therefore, the requested information regarding acceptance criteria and a study proving device performance as traditionally understood for a new device submission is not explicitly detailed in this document. The submission focuses on hardware and software description, intended use, and equivalence to a predicate device.

However, based on the provided text, we can infer some aspects related to "acceptance criteria" through the definition of Microvolt T-wave Alternans (MTWA) and the general claims of safety and effectiveness.

Here's an attempt to answer the questions based on the provided text, highlighting where information is absent or inferred:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria and device performance as would be expected for a primary clinical trial or analytical validation of a new device. Instead, the "acceptance criteria" are embedded within the definition of Microvolt T-wave Alternans (MTWA), which the device is designed to measure. The "reported device performance" is a claim of substantial equivalence and safety/effectiveness based on the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As this is a 510(k) submission for a modification based on substantial equivalence, a new large-scale clinical test set for the modified classifier's performance is not detailed. The submission relies on the established performance of the predicate device and the analytical validation of the software change.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. No specific test set with expert-established ground truth is described for the modified classifier. The general statement mentions that the "interpretive results... should be reviewed by a qualified physician," but this pertains to clinical usage, not ground truth establishment for a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

There is no indication that an MRMC comparative effectiveness study was done for this specific modification. The "Alternans Report Classifier" provides an "indication" to the clinician, but no study is presented to quantify how this "assistance" improves human reader performance or its effect size.

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

A standalone performance study for the modified classifier is not explicitly detailed. The document focuses on the system as an adjunct to clinical history and other tests, with final review by a physician. The classifier itself generates "positive, negative, or indeterminate results," implying an algorithmic output, but a standalone performance study with metrics like sensitivity, specificity, or accuracy against an independent ground truth is not presented.

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

The document does not specify the type of ground truth used for validating the modified classifier. For the underlying science of MTWA, the "Indications for Use" state that its presence predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death), suggesting a correlation with clinical outcomes data for the broader concept of MTWA detection. However, for the specific classifier's validation, this is not detailed.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

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