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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 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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