Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is intended to be used in a hospital or clinic environment by competent health professionals utilizing recorded ECG data to produce a numerical score which is the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction). Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitute for the physician's decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings. ACI-TIPI is intended for adult patient populations.

Device Description

Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is a software option for Marquette MAC-series electrocardiographs to aid the physician's decision-making process in a chest pain setting by using patient age, gender, chest pain status and ECG features to provide the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction).

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets them. Instead, it focuses on the device's substantial equivalence to a predicate device and its intended use.

However, based on the information provided, we can infer some details:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria. The performance claim is a qualitative comparison to the predicate device.

Acceptance Criteria	Reported Device Performance
Not explicitly stated	"ACI-TIPI analysis is as safe, as effective, and performs as well as the predicate device, Hewlett-Packard Model 1791A ACI-TIPI."

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

The document does not specify the sample size used for any test set or the data provenance.

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

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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 mention of an MRMC comparative effectiveness study or the effect size of human reader improvement with AI assistance. The device is intended to supplement a physician's decision, not replace it, which suggests it might be used in conjunction with human readers, but no study details are provided.

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

The document mentions "software testing and field tests of the ACI-TIPI analysis," but it doesn't explicitly state whether a standalone performance study was conducted. The nature of the device as a "predictive instrument" producing a numerical score implies an algorithm-only component.

7. The type of ground truth used

The document does not specify the type of ground truth used for performance evaluation. It notes the device calculates "the predicted probability of acute cardiac ischemia (which includes unstable angina pectoris and acute myocardial infarction)." The "ground truth" would presumably relate to the actual occurrence of these conditions.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of Study Information Provided in the Document:

The provided text primarily focuses on the regulatory submission for substantial equivalence. The "Performance" section briefly states that "The following quality assurance measures were applied to the development of ACI-TIPI: Requirements specification review, software testing and field tests of the ACI-TIPI analysis." It then concludes, "The results of these measurements demonstrated that ACI-TIPI analysis is as safe, as effective, and performs as well as the predicate device, Hewlett-Packard Model 1791A ACI-TIPI."

This statement indicates that some form of internal testing was conducted to demonstrate equivalence to the predicate device, but the details of these tests (sample sizes, ground truth establishment, expert involvement, specific metrics) are not disclosed in this summary. The regulatory approval is based on substantial equivalence, implying that the predicate device already had established performance.

Summary

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K974199

SECTION 2 - SUMMARY AND CERTIFICATION

FEB 6 1998

-2.1 510(k) Summary of Safety and Effectiveness

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter:	Marquette Medical Systems, Inc.8200 W. Tower AvenueMilwaukee, WI 53223Telephone: (414) 355-5000FAX: (414) 362-3553
Contact Person:	Kristin Pabst
Device:	Trade Name: Acute Cardiac Ischemia Time-Insensitive PredictiveInstrument (ACI-TIPI) OptionClassification Name: Computer, diagnostic, programmableDetector and Alarm, Arrhythmia
Predicate Device:	Hewlett-Packard Model 1791A ACI-TIPI
Device Description:	Acute Cardiac Ischemia Time-Insensitive Predictive Instrument(ACI-TIPI ) Option is a software option for Marquette MAC-serieselectrocardiographs to aid the physician's decision-making process ina chest pain setting by using patient age, gender, chest pain statusand ECG features to provide the predicted probability of acute cardiacischemia (which includes unstable angina pectoris and acutemyocardial infarction).
Intended Use:	Acute Cardiac Ischemia Time-Insensitive Predictive Instrument(ACI-TIPI ) Option is intended to be used in a hospital or clinicenvironment by competent health professionals utilizing recordedECG data to produce a numerical score which is the predictedprobability of acute cardiac ischemia. Like any computer-assisted ECGinterpretation program, the Marquette ACI-TIPI evaluation andprobability score is intended to supplement, not substitute for thephysician's decision process. It should be used in conjunction withknowledge of the patient's history, the results of a physicalexamination, the ECG tracing, and other clinical findings.ACI-TIPI is intended for adult patient populations.
Technology:	ACI-TIPI option employs the same technology as the predicatedevice.
Performance:	The following quality assurance measures were applied to thedevelopment of ACI-TIPI.
	Requirements specification review, software testing and field tests ofthe ACI-TIPI analysis.

510(k) Notification "ACI-TIPI" November 7, 1997
66

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The results of these measurements demonstrated that ACI-TIPI analysis is as safe, as effective, and performs as well as the predicate device, Hewlett-Packard Model 1791A ACI-TIPI.

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Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.

Rockville MD 20857

FEB 6 1998

Ms. Kristin Pabst Regulatory Affairs Manager Marquette Medical Systems, Inc. 8200 West Tower Avenue Milwaukee, WI 53223

K974199 Re : Acute Cardiac Ischemia Time-Intensive Predictive Instrument (ACI-TIPI) Option Regulatory Class: III (three) Product Code: 74 LOS Dated: November 7, 1997 Received: November 10, 1997 -------

Dear Ms. Pabst:

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 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, Drug, 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 to 895. A substantially equivalent determination assumes compliance 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 requlations.

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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 requlation (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/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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6 1998 FEB

SECTION 11 - INTENDED USE STATEMENT

Unknown - 510(k) filed August 29, 1997 510(k) Number (if known):

Device Name: Acute Cardiac Ischemia Time-Insensitive Instrument (ACI-TIPI)

Indications For Use:

Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI ) Option is intended to be used in a hospital or clinic environment by competent health professionals . TIPI utilizes recorded ECG data along with patient demographic and chest pain status to produce a numerical score which is the predicted probability of acute cardiac ischemia. Like any computer-assisted ECG interpretation program, the Marquette ACI-TIPI evaluation and probability score is intended to supplement, not substitue for the physician's decision process. It should be used in conjunction with knowledge of the patient's history, the results of a physical examination, the ECG tracing, and other clinical findings.

ACI-TIPI is intended for adult patient populations.

M. Puye
(Division Sign-Off)

and Seurolog 510(k) Num

Regulation Number and Section

N/A