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The Cambridge Heart MTWA OEM Module is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvott T-Wave Alternans* at rest and during ECG stress testing.

The presence of Microvolt T-wave Atternans as measured by the Analytic Spectral Method of the MTWA OEM Module in patients with known, suspected or at risk of ventricular tachyarrhythmia predicts increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death).

The MTWA OEM Module 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 MTWA OEM Module 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 highresolution 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 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 MTWA OEM Module consist of a patient module and an analysis software operating on a PC platform meeting the technical requirement specified in Product Requirement Document (PRD) for the module. The MTWA OEM Module is intended for the recording of electrocardiograms, vector cardiograms and measurement of Microvolt T-Wave Alternans* at rest and during ECG stress testing. The alternans levels reported in K983012, K001034, K003492 and K022149, K050225 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 MTWA OEM Module provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of Alternans Processing used in the Cambridge Heart MTWEA OEM Module 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 MTWA OEM Module 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 MTWA OEM Module.

The provided document is a 510(k) premarket notification summary for the Cambridge Heart MTWA OEM Module. It focuses on demonstrating substantial equivalence to a predicate device (HearTwave II Cardiac Diagnostic System K050225) rather than providing a detailed study proving the device meets specific acceptance criteria with performance metrics.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not explicitly stated in this type of regulatory submission. The submission primarily emphasizes that the new device uses the same analytical method and software as its predicate and that validation confirmed identical performance.

Here's the information that can be extracted or inferred from the document, along with what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

• Data Management capability
• Main Application and Processing Screens functionality
• Printing functionality
• System Setup & Configuration
• MTWA Algorithm results
• ECG Processing
• Overall System Performance | Validation parameters verified that all compatibility requirements are met and that the performance of the Cambridge Heart TWA OEM module is identical to its predicate device. |
  | Clinical Efficacy (as per Indications for Use):
• Prediction of increased risk of a cardiac event (ventricular tachyarrhythmia or sudden death) in patients with known, suspected, or at risk of ventricular tachyarrhythmia. | 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 relies on prior studies of the predicate device/method, not new performance data in this submission). |

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. The validation involved testing the OEM Module incorporated into the Cardiac Science Q-Stress System (K082173). The document mentions "Validation parameters verified that all compatibility requirements are met and that the performance... is identical," but does not detail the size or nature of the test dataset used for this validation.
• Data Provenance: Not explicitly stated for specific validation data. The prior clinical utility of the Analytic Spectral Method was established in previous 510(k) submissions (K983012, K001034, K003492, K022149, K050225), which would have involved clinical data, but the specifics of that data (country of origin, retrospective/prospective) are not in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not stated. The validation focused on functional and performance identity with the predicate, not on clinical ground truth establishment for a diagnostic study using expert consensus. The "interpretive results of the MTWA OEM Module should be reviewed by a qualified physician," but this is a statement about clinical use, not about expert input for ground truth in a validation study.

4. Adjudication method for the test set

• Not stated.

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

• A MRMC comparative effectiveness study was not reported in this document. The device is a quantitative measurement tool (Microvolt T-Wave Alternans) designed to predict risk, not a direct "AI assistance" tool for human readers in the sense of image interpretation.

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

• Yes, the performance validation of the "MTWA Algorithm" and "ECG Processing" was part of the overall system validation. The core of the device is the automated measurement of Microvolt T-Wave Alternans using the Analytic Spectral Method. The document states its output "has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death," implying standalone algorithmic performance. However, the device is explicitly intended "as an adjunct to clinical history and the results of other non-invasive and/or invasive tests" and its results "should be reviewed by a qualified physician," meaning it's not designed for fully standalone clinical decision-making.

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

• For the validation performed for this 510(k), the "ground truth" was likely the expected output/performance of the predicate device (K050225) on identical inputs, ensuring the new module produced the same analytic results.
• For the clinical utility of the Analytic Spectral Method in predicting cardiac events (which this device inherits from its predicate), the ground truth in those foundational studies would have been outcomes data (e.g., occurrence of ventricular tachyarrhythmia or sudden death over a follow-up period).

8. The sample size for the training set

• Not applicable/Not stated. This submission is for a modification of an existing device/algorithm. It leverages an established analytical method (Analytic Spectral Method) and therefore doesn't explicitly describe a new "training set" for a de novo AI model. The method itself was likely developed and "trained" on various ECG datasets historically, but those details are not in this document.

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

• Not applicable/Not stated, as this submission doesn't detail the training of a new algorithm. For the original development of the Analytic Spectral Method, the ground truth for its development would have involved correlating T-wave alternans measurements with cardiac event outcomes, likely established through extensive clinical research and data collection where "ground truth" was determined by clinical event follow-up.

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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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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.

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