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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 Model CH 2000 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 Analytic Spectral Method of the Model CH2000 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 Model CH2000 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 Model CH2000 Cardiac Diagnostic 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, 2001 (K013565). 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. Microvolt T-wave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.

The Model CH2000 Cardiac Diagnostic System provides T-wave alternans diagnostic capabilities to standard stress labs. The Analytic Spectral Method of Alternans Processing used in the CH2000 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 CH2000.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cambridge Heart Model CH2000 Cardiac Diagnostic System.

Acceptance Criteria and Device Performance Study for Cambridge Heart Model CH2000 Cardiac Diagnostic System (K022149)

It's important to note that this 510(k) submission (K022149) is a Special 510(k) for a modification to an already cleared device (K013565). The primary purpose of a Special 510(k) is to demonstrate that a design change does not significantly alter the safety or effectiveness of the device as it pertains to its original substantial equivalence. As such, the documentation focuses on showing the modified device maintains its equivalence rather than presenting an entirely new clinical performance study with acceptance criteria in the traditional sense for a de novo submission.

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, 2001 (K013565)." Therefore, the "acceptance criteria" here are implicitly tied to demonstrating continued substantial equivalence and safety/effectiveness after this software parameter change.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the modified software parameter. Instead, the "acceptance criteria" for this Special 510(k) are met by demonstrating that the modification does not change the core functionality, safety, or effectiveness compared to the predicate device.

The "reported device performance" is essentially that the modification maintains the device's original intended use and analytical method.

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

The provided 510(k) summary does not contain information about a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the specific software parameter modification. For a Special 510(k) of this nature, extensive clinical testing might not be required if the modification is deemed minor and does not impact safety or effectiveness. The substantiation typically relies on verification and validation of the software change internally, often against a pre-existing dataset, but details of such testing are not provided in this public summary.

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

This information is not provided in the submitted 510(k) summary. Given the nature of a Special 510(k) for a software parameter change, it's possible that formal expert adjudication for a new "ground truth" test set was not deemed necessary for this specific submission, especially if the change was validated against an existing, already established dataset.

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A MRMC comparative effectiveness study was not described in this 510(k) summary. The document focuses on a software parameter modification and demonstrating substantial equivalence, not on the comparative effectiveness of human readers with or without AI assistance for the Model CH2000 device itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

While the "Alternans Report Classifier software provides the clinician with an indication of positive, negative, or indeterminate result," and this is the specific component being modified, the submission does not explicitly describe a standalone performance study for this modified component in isolation. The document states: "The results remain subject to the final review of a qualified medical practitioner," indicating a human-in-the-loop design. The current 510(k) focuses on maintaining prior demonstrated performance.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for evaluating the modified software parameter. For the original clearance (K013565) of the Model CH2000, the "ground truth" for the predictive value of T-wave Alternans for cardiac events would typically be actual cardiac events (ventricular tachyarrhythmia or sudden death) observed in patient cohorts. However, for a minor software modification, the 'ground truth' for validation might be internal reference data or physician-adjudicated existing case data.

8. The Sample Size for the Training Set

The provided 510(k) summary does not contain information about the sample size for a training set. Given the modification is to an existing "Classifier software," it implies the original software would have been developed and possibly trained on a dataset, but details are not included here. This Special 510(k) focuses on the change to a parameter in an already cleared classifier.

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

The provided 510(k) summary does not contain information on how the ground truth for the training set was established. This detail would typically be found in documentation for the original device clearance (K013565), not for a special 510(k) for a minor software change.

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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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The Model CH 2000 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 Analytic Spectral Method of the Model CH2000 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 Model CH2000 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 measured from high roosadiacent precordial leads, (c) is at the level of 1.9 microvolts after signal optimization and subtraction of the 1.5 millerovolis - and - Signal - Signal - Signal - Standard deviations greater background noise lovel, (a) is all (e) has an onset heart rate at or below than the buongrounde, and (f) is sustained for all heart rates above the onset heart rate.

The Model CH2000 Cardiac Diagnostic System is intended for the measurement The Model Of I2000 Ourdial Diagnoction of over in the subject of this and rooverally of the inclusion of the Alternans Report Classifier pre manter submission is the or marketing on October 11, 2001 (K012206). SUltware which was olourou for manages the clinician with an indication of positive, Olassinoution soltware promate for the Alternans Trend Reports. The results negative, of indotominate review of a qualified medical practitioner. Microvolt Twave Alternans has been shown to be useful in predicting ventricular tachyarrhythmias and sudden cardiac death.

The Model CH2000 Cardiac Diagnostic System provides T-wave alternans The Model Of ILOGO Caralde Blagf stress labs. The Analytic Spectral Method of diagnostic capabilities to clain the CH2000 is intended for the measurement of Microvolt T-wave alternans at rest and during treadmill, ergometer and Microvon' I wave allemans 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 The allorhand tool as a long the relectrodes and seven proprietary portumou with 65%-V Alternans™ Sensors. The electrodes and sensors are maill sogmont Misro · Ailematter the belt-worn patient module, which provides digitized data to the CH2000.

The provided text is a 510(k) summary for the Cambridge Heart Model CH2000 Cardiac Diagnostic System. It describes the device, its intended use, and its relation to predicate devices. However, it does not contain the acceptance criteria or a study that proves the device meets those criteria. The document focuses on regulatory approval based on substantial equivalence to previously cleared devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document states: "The Model CH2000 Cardiac Diagnostic System uses the same Analytic Spectral Method as the Heartwave™ for measuring T-Wave Alternans, but also includes standard exercise stress test capability. The Alternans Report Classifier to be used with the CH2000 was cleared for marketing on October 11, 2001 (K012206)." This statement implies that the Analytic Spectral Method for T-wave alternans measurement was previously validated, and this new submission focuses on the integration of that method into a new system (CH2000) and the addition of a new "Alternans Report Classifier" software module.

The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical performance studies to establish standalone performance or acceptance criteria for a novel technology. The document indicates that "There are more similarities than differences between the predicate devices and the Cambridge Heart Model CH2000 Cardiac Diagnostic System. All predicate devices use the Analytic Spectral Method. When used by qualified personnel in accordance with the directions for use, the Model CH2000 Cardiac Diagnostic System with with the directions for aco, the model offective, as indicated, for its intended use."

The document lists Performance Standards which are related to electrical safety, electromagnetic compatibility, and general requirements for safety, not clinical performance or accuracy of the T-wave alternans measurement itself. These are:

• ANSI/AAMI EC11-1991
• EN60601-1: 1988, "Medical Electrical Equipment, Part 1: General Requirements for Safety" including Amendments A1 and A2
• EN60601-1-1: 1993, "Medical Electrical Equipment, Part 1: General Requirements for Safety - Section 1.1 Collateral standard: Safety requirements for medical electrical systems"
• EN60601-1-2: 1993, "Medical Electrical Equipment, Part 2: Collateral Standard: Electromagnetic Compatibility - Requirements and Tests"
• UL2601-1, "Medical Electrical Equipment, Part 1: General Requirements for Safety" 2nd Edition, including Amendments A1 and A2
• CAN/CSA C22.2 No. 601.1-M90, "Medical Electrical Equipment, Part 1: General Requirements for Safety" including C22.2 No. 601.1S1-94 (IEC 601-1. Amendment 1:1991)

These are engineering and electrical safety standards, not clinical performance metrics or acceptance criteria for diagnostic accuracy. The 510(k) summary does not contain the information required to answer your specific questions about acceptance criteria or performance studies as typically expected for algorithms involving AI or novel diagnostic claims.

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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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