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The MAC Series Resting ECG Analysis Systems (Includes the MAC PC, MAC 6, MAC VU, MAC 8, and MAC 5000) are intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The MAC Series is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The Mac Series consists of electrocardiograph models designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The devices consist of two basic components: the processing unit and patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment.

The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of ORS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The provided document describes a 510(k) submission for the GE Marquette Medical Systems MAC Series Resting ECG Analysis Systems. This submission is focused on demonstrating substantial equivalence to predicate devices, rather than a de novo approval requiring a detailed clinical study with pre-defined acceptance criteria and reported performance metrics. Therefore, the information typically requested regarding acceptance criteria and a study proving device adherence to these criteria is not fully available in this type of submission.

However, based on the provided text, we can infer some aspects and extract relevant information.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or a dedicated performance study with specific metrics like sensitivity, specificity, or accuracy that would be typical for a de novo device. Instead, the focus is on the device's technological characteristics not raising "new questions of safety or effectiveness" compared to predicate devices. This indicates that the performance is implicitly expected to be at least equivalent to the predicate devices.

The "Test Summary" section states: "The MAC Series complies with the voluntary standards as detailed in Section 9 Test Summary." This implies that the device was tested against applicable industry standards, and compliance with these standards serves as the primary "acceptance criteria" for this type of submission. Without Section 9, the specific standards and their associated performance thresholds cannot be detailed.

Inferred "Acceptance Criteria" (Compliance with Predicate Devices and Standards):

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

The provided text does not specify a distinct "test set" sample size or its data provenance (country of origin, retrospective/prospective). This is common for 510(k) submissions focusing on substantial equivalence, where the "study" often involves comparison to predicate device specifications and internal verification/validation testing against standards, rather than a large-scale clinical trial with patient data for performance metrics.

For an ECG analysis system, testing would typically involve a database of ECG recordings used to validate the accuracy of the interpretive algorithms, but details of such a dataset are not provided here.

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

The submission does not detail the number or qualifications of experts used to establish ground truth for any specific "test set." The device is intended to provide "computerized ECG analysis program which can be used as a tool in ECG tracing interpretation" and explicitly states: "All computer-generated tracings should be overread by a qualified physician." This indicates that the ultimate "ground truth" in clinical practice for individual patient care rests with a qualified physician.

If the underlying "Marquette 12SL Analysis Program" (K964750) predicate device underwent rigorous validation, that would have involved expert consensus for ground truth, but those details are not in this document.

4. Adjudication Method for the Test Set

No details on an adjudication method (such as 2+1 or 3+1) are provided, as a specific "test set" and a corresponding expert-adjudicated ground truth study are not explicitly described in this 510(k) summary.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating how much human readers improve with AI vs. without AI assistance is not mentioned or described in the provided text. This type of study is more common for novel diagnostic algorithms where human-AI interaction is being specifically assessed. The MAC Series system is presenting an "interpretation" to be "overread by a qualified physician," implying a supportive role rather than an assistive AI system in the modern sense that mandates MRMC studies.

6. Standalone Performance Study (Algorithm Only)

While the device incorporates a "computerized ECG analysis program" (likely the Marquette 12SL Analysis Program), the provided text does not describe a standalone performance study (i.e., algorithm only, without human-in-the-loop performance) for this specific 510(k) submission.

The fact that it mentions "Marquette 12SL Analysis Program - K964750" as a predicate device suggests that the performance of the core analysis algorithm would have been established during the clearance of K964750. This current submission likely concerns updates to the hardware (MAC Series devices) and the integration of this established analysis program, ensuring that the integration does not degrade its performance.

7. Type of Ground Truth Used

The type of ground truth used for any internal validation of the "computerized ECG analysis program" in the underlying 12SL program is not specified in this document. For ECG interpretive algorithms, ground truth is typically established through:

• Expert Consensus: A panel of cardiologists independently reviewing ECGs and patient records to reach a consensus diagnosis.
• Clinical Outcomes/Follow-up: Correlating ECG findings with subsequent clinical events or diagnoses.
• Pathology/Other Definitive Tests: For certain conditions, correlation with more definitive diagnostic procedures.

The caution explicitly stating that the "computerized interpretation is only significant when used in conjunction with clinical findings" and must be "overread by a qualified physician" underscores that the device's output is an aid, not a definitive diagnosis, and relies on clinical context and expert review for ultimate truth.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the ECG analysis algorithms. As noted, this is a 510(k) for a device incorporating an existing analysis program (12SL), so details about the training of that program would reside with its original submission (K964750) or internal development documentation.

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

Similar to the training set sample size, the method for establishing ground truth for any training set used for the ECG analysis algorithms is not described in this document. This information would be specific to the development and validation of the "Marquette 12SL Analysis Program" (K964750) that is integrated into the MAC Series systems.

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