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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 modour. The first fight 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 than the backgrounde, and (f) is sustained for all heart rates above the onset heart rate.

The Heartwave™ Alternans Processing System is intended for the measurement The recording of T-Wave alternans. The modification which is the subject of this arra rooveraing of the inclusion of the Alternans Report Classifier software which was cleared for marketing on October 11, 2001 (K012206). 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 nharmacologic 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.

The provided 510(k) summary for the K013564 Heartwave™ Alternans Processing System does not contain the specific details about acceptance criteria, a standalone study, or a multi-reader multi-case (MRMC) comparative effectiveness study with effect sizes. It focuses more on the device's indications for use, description, and regulatory equivalence.

However, based on the information available, here's what can be extracted and what information is missing:

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

This information is not explicitly provided in the given 510(k) summary. The document describes the definition of Microvolt T-wave Alternans (e.g., "at the level of 1.9 microvolts," "at least three standard deviations greater than the background noise level") which might imply internal performance metrics, but it does not present a table of acceptance criteria with corresponding reported device performance values.

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 given 510(k) summary. The document mentions the device is used "in patients with known, suspected or at risk of ventricular tachyarrhythmia," but it doesn't describe any specific clinical study data (sample sizes, provenance, or study design) used for validation.

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 given 510(k) summary. The document states that "The interpretive results of the Alternans Processing System should be reviewed by a qualified physician," implying expert involvement in clinical practice, but it doesn't speak to expert involvement in a formal study setting for ground truth establishment.

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

This information is not provided in the given 510(k) summary.

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 a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size of human improvement with AI assistance, in the provided 510(k) summary. The device's "Alternans Report Classifier software which was cleared for marketing on October 11, 2001 (K012206)" provides "an indication of positive, negative, or indeterminate result for the Alternans Trend Reports," and states "The results remain subject to the final review of a qualified medical practitioner." This suggests that the software is an adjunct or aid, but not that a formal study of its impact on human reader performance was conducted and reported here.

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

The provided information does not explicitly state if a standalone performance study was done for the "Alternans Report Classifier software." While the device measures Microvolt T-wave Alternans, the summary focuses on its intended use as an adjunct tool.

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

This information is not explicitly provided in the given 510(k) summary regarding any specific study. The "Indications for Use" state that the presence of T-wave Alternans "predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death)." This suggests that outcomes data (actual cardiac events) would be the ultimate ground truth for validating predictive value, but the document doesn't detail how this was established in any specific study for the clearance.

8. The sample size for the training set

This information is not provided in the given 510(k) summary.

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

This information is not provided in the given 510(k) summary.

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