Search Results

The 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 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 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 Cambridge Heart Alternans Processing System is intended for use with computerbased ECG systems which include the feature for the measurement and recording of T-Wave alternans at rest and during treadmill, ergometer, electrophysiological, and pharmacologic stress testing. The Alternans Processing System uses the Analytic Spectral Method which 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 alternans levels reported in K983102 were measured using the Analytic Spectral Method.

The Alternans Processing System is embodied in software and can be incorporated into a device for the measurement of T-Wave alternans. The Cambridge Heart Alternans Processing System adds T-wave alternans diagnostic capabilities to standard stress test systems and ECG recording devices.

The Alternans Processing System is embodied in two legally marketed products, the Model CH2000 Cardiac Diaqnostic System (K983102) and the Heartwave Alternans Processing System (K001034). It is designed for use in conjunction with a host adapter/controller for ECG functions. The host may be any ECG recording or stress test system. In the case of the Model CH 2000 Cardiac Diagnostic System the host controller is an integral part of the device (K983102).

Attachment to the patient is through the Cambridge Heart patient module(s). Digitized signals from the patient module are used as inputs to the Alternans Processing System.

The Alternans test using the Alternans Processing System 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 Alternans Processor.

The Alternans Processing System uses interpretive Alternans Report Classifier software that provides an assessment of the alternans report data to assist the physician in diagnosis. The computerized assessment is printed at the bottom of the alternans report and indicates that the result is consistent with a Positive, Negative, or Indeterminate finding. This assessment should be considered preliminary and should be reviewed by a qualified physician. Alternans results should always be used as an adjunct to clinical history and the results of other non-invasive or invasive tests.

The provided text is a 510(k) summary for the Cambridge Heart Alternans Processing System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's indications for use and technical description.

However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance sections of a 510(k) submission. The document emphasizes substantial equivalence to previously cleared devices (K983102 and K001034) that already utilize the Analytic Spectral Method for T-wave alternans measurement. Therefore, direct evidence of a new study with specific acceptance criteria is not presented here.

Based on the provided text, I can extract the following relevant information regarding performance and study details, though it does not fully address all points of your request for new acceptance criteria and a new study validation:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify new acceptance criteria or report performance against new criteria. Instead, it refers to the performance of the underlying Analytic Spectral Method, which was previously established and cleared.

The alternans levels reported in K983102 (a predicate device using the same method) were measured using the Analytic Spectral Method. |
| Performance Standards Met:

• ANSI/AAMI EC11-1991
• EN60601-1: 1988 (with A1, A2)
• EN60601-1-1: 1993
• EN60601-1-2: 1993
• UL2601-1 (2000 Ed., with A1, A2)
• CAN/CSA C22.2 No. 601.1-M90 (with C22.2 No. 601.1S1-94) | The Cambridge Heart HeartWave™ Alternans Processing System and the Cambridge Heart Model CH 2000 Cardiac Diagnostic System (which incorporate the Analytic Spectral Method) meet these listed performance standards. |

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

The provided document does not mention a specific sample size used for a test set or the data provenance (e.g., country of origin, retrospective/prospective) for a new study. The submission relies on the established performance of the Analytic Spectral Method used in predicate devices.

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

The document does not specify the number or qualifications of experts used to establish ground truth for a test set. The interpretive results are "preliminary and should be reviewed by a qualified physician," but this refers to the use of the device in practice, not its validation study.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for a test set.

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

An MRMC comparative effectiveness study is not mentioned in the provided text. The device offers an "interpretive Alternans Report Classifier software that provides an assessment... to assist the physician in diagnosis," but there is no study comparing human reader performance with and without this assistance.

6. Standalone (Algorithm Only) Performance Study

The document implies standalone performance validation through its reference to the Analytic Spectral Method's established utility. It 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." This "shown to be useful" likely refers to prior studies that led to the clearance of predicate devices, implicitly validating the algorithm's standalone capability. However, no specific standalone study details (like metrics or dataset) are provided in this document.

7. Type of Ground Truth Used

For the underlying Analytic Spectral Method, the "usefulness" is cited in terms of predicting ventricular tachyarrhythmias and sudden cardiac death (outcomes data). However, for this specific 510(k) submission, the primary "ground truth" for showing equivalence seems to be alignment with the performance of previously cleared devices using the same Analytic Spectral Method. No new specific type of ground truth for a new validation study is mentioned.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for a training set. As this is a 510(k) relying on substantial equivalence of an existing method, new training details are not typically required if the underlying algorithm is unchanged.

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

The document does not provide any information on how ground truth for a training set was established.

Ask a specific question about this device