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.

Device Description

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.

AI/ML Overview

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):

Acceptance Criteria Category	Description	Reported Device Performance (Inferred from Submission)
Safety & Effectiveness	The technological characteristics of the MAC 5000 and related MAC Series devices do not raise new questions of safety or effectiveness compared to predicate devices (Marquette Option II ECG Analysis Computer for MAC I - K820885, and Marquette 12SL Analysis Program - K964750). The device performs its intended functions (acquire, analyze, display, and record ECG signals from surface electrodes from adult and pediatric populations) reliably and safely.	"Data in this submission demonstrate that these technological characteristics do not raise new questions of safety or effectiveness." This implies that the device's intrinsic safety and effectiveness are considered comparable to the predicate devices and sufficient for its intended use, based on the testing and comparisons detailed in the full submission (which is beyond the provided snippets).
Voluntary Standards Compliance	Compliance with relevant voluntary standards (as detailed in Section 9 of the full submission) for electrocardiographs and associated analysis systems. This would typically include electrical safety standards (e.g., IEC 60601-1), EMC standards, and potentially performance standards for ECG acquisition and analysis if applicable at the time.	"The MAC Series complies with the voluntary standards as detailed in Section 9 Test Summary." Without access to Section 9, specific performance metrics are unavailable.
Functional Equivalence	The device can acquire, analyze, display, and record ECG signals from surface ECG electrodes, offering 3, 6, 12, or 15 lead interpretive analysis, vector loops, and upgrade options for high-resolution signal averaging. It should be capable of transmitting and receiving ECG data.	The device description explicitly states these capabilities: "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 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."
Intended Use	The device is suitable for use under the direct supervision of a licensed healthcare practitioner by trained operators in a hospital or medical professional's facility environment for adult and pediatric populations. The computerized interpretation is a tool to be used in conjunction with clinical findings and should be overread by a qualified physician. This is not a performance metric but an acceptance of the appropriate context of use.	This is explicitly stated in the "Intended Use" section and the caution note, defining the operational boundaries rather than a measured performance.

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.

Summary

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AUG 18 1999 16:27 FR GE MARQUETTE FINANCE 414 362 2420 TO 913014804204

P.07/08
Lbt A K99/725

AUG 19 1999

510(k) Summary of Safety and Effectiveness
May 21, 1999 Date:

GE Marquette Medical Systems, Inc. Submitter: 8200 W. Tower Ave. Milwaukee, WI 53223 USA

David Wahlig Contact Person: Corporate Regulatory Affairs GE Marquette Medical Systems Phone: (414) 362-2090 Fax: (414) 355-3790

Classification Names & Citations:

21 CFR 870,1425	Programmable diagnostic computer	74DQK
21 CFR 870.2920	Transmitters and Receivers, Electrocardiograph, Telephone	74DXH
21 CFR 870,2340	Electrocardiograph	74DPS
21 CFR 870.2340	System, ECG Analysis	74LOS

Marquette Option II ECG Analysis Computer for MAC I Electrocardiograph Predicate Devices: (MAC II) - K820885

Marquette 12SL Analysis Program - K964750

The Mac Series consists of electrocardiograph models designed to acquire, Device Description: 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.

Intended Use: The MAC Series is intended to be used under the direct supervision of a licensed healthcare practitioner. The MAC Series is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The devices are intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.

Technology: The technological characteristics of the MAC 5000 and related MAC Series devices have been updated to reflect use of current technology and to incorporate user-requested features. Data in this submission demonstrate that these technological characteristics do not raise new questions of safety or effectiveness.

The MAC Series complies with the voluntary standards as detailed in Section 9 Test Summary:

MAC Series electrocardiographs including MAC 5000, MAC PC, MAC 6, Trade/Proprietary Name: MAC VU, MAC 8

Electrocardiograph Common/Usual Name:

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Responsibility of the Manufacturer

GE Marquette Medical Systems, Inc. is responsible for the effects of safety, reliability, and performance only if:

Assembly operations, extensions, readjustments, . modifications, or repairs are carried out by persons authorized by GE Marquette.
The electrical installation of the relevant room complies with the requirements of the appropriate regulations.
트 The equipment is used in accordance with the instructions for use.

General Information

Intended Use

The intended use of this device is to record ECG signals from surface ECG electrodes. This device can analyze, record, and store electrocardiographic information from adult and pediatric populations. This data can then be computer analyzed with various algorithms such as interpretive ECG and signal averaging for presentation to the user.

This device is intended for use under the direct supervision of a licensed health care practitioner.

This device is not intended for use with high frequency surgical units. Disconnect the patient from the device before using the high frequency surgical unit.

Caution:

Bold>

This equipment uses a computerized ECG analysis program which can be used as a tool in ECG tracing interpretation. This computerized interpretation is only. significant when used in conjunction with clinical findings. All computer-generated tracings should be overread by a qualified pician

MAC 5000 System -- 418625-010, Revision A

1-7

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 1999

Mr. David Wahlig -GE Marquette Medical Systems 8200 W. Tower Avenue - Milwaukee, WI 53223

Re: K991735 MAC 5000 and Related MAC Series Resting ECG Analysis Systems Regulatory Class: III (three) Product Code: 74 LOS, DQK, DPS, and DXH Dated: May 21, 1999 Received: May 21, 1999

Dear Mr. Wahlig:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Mr. David Wahlig

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro -diagnostic devices), please contact the Office of Compliance at (301) 594–4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Unknown;

510(k) filed on 21 May, 1999

May, 1999

・・

MAC Series Resting ECG Analysis System Device Name:

Indications For Use:

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.

. .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K991735
Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

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Regulation Number and Section

N/A