Acute Cardiac Ischemia Time-Insensitive 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-TIP! 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 document is a 510(k) summary for the Acute Cardiac Ischemia Time-Insensitive Predictive Instrument (ACI-TIPI) Option. This document states that the ACI-TIPI Option is substantially equivalent to a predicate device, the Hewlett-Packard Model 1791A ACI-TIPI. However, it does not explicitly define specific acceptance criteria (e.g., sensitivity, specificity thresholds) or provide a detailed study report with device performance metrics against those criteria. Instead, it asserts equivalence based on developmental quality assurance measures.

Here's an analysis of the provided information:

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

The document does not specify quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or predictive values) for the ACI-TIPI Option. It states that "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 implies that the acceptance criterion was likely demonstration of substantial equivalence to the predicate device, rather than specific performance thresholds.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for a test set, data provenance (country of origin), or whether the data was retrospective or prospective. It generally refers to "software testing and field tests of the ACI-TIPI analysis," but no specifics are given.

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)

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication method for establishing ground truth for a 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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The intended use explicitly states that the device is "intended to supplement, not substitute for the physician's decision process," suggesting a physician-in-the-loop scenario, but no study details are provided to evaluate this.

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

The document does not explicitly state whether a standalone (algorithm only) performance evaluation was done. Given the context of a 510(k) for substantial equivalence to a predicate device, it's possible that internal testing would have included such an evaluation, but it is not reported in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not specify the type of ground truth used for performance evaluation. It states that the device uses "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)." To establish ground truth for "acute cardiac ischemia," one would typically expect clinical outcomes data, such as cardiac enzyme levels, angiography results, or follow-up for adverse cardiac events, but this is not detailed.

8. The sample size for the training set

The document does not provide any information regarding the sample size of a training set. This is consistent with a pre-AI/machine learning era device, where "training" in the modern sense might not have been applicable. The device "employs the same technology as the predicate device," suggesting its design is based on established methods rather than a modern learning-based approach.

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.

Summary of what is present:

Acceptance Criteria: Implicitly, "substantial equivalence" to the predicate device (Hewlett-Packard Model 1791A ACI-TIPI).
Reported Device Performance: "as safe, as effective, and performs as well as the predicate device" based on "Requirements specification review, software testing and field tests of the ACI-TIPI analysis."
Device Description: Software option for Marquette MAC-series electrocardiographs.
Intended Use: Aid physician decision-making in a chest pain setting, using patient age, gender, chest pain status, and ECG features to predict the probability of acute cardiac ischemia. Intended to supplement, not substitute, physician's decisions and for adult patient populations.
Technology: Employs the same technology as the predicate device.

The provided 510(k) summary is from 1998, a period when regulatory expectations for demonstrating performance for software-based medical devices were less detailed compared to current standards for AI/ML devices. Therefore, it lacks the specific quantitative metrics, detailed study designs, and ground truth methodologies that are common in more recent submissions.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Antony R. H. Fender · Official FDA Correspondent Jack's Electrodes, Inc. 2227 East Crescent Drive Altadena, California 91001

JAN 28 1998

Re: K974119 Disposable Needle Electrode (ALM and DLM) Trade Name: Regulatory Class: II Product Code: GXZ Dated: September 4, 1997 Received: October 31, 1997

Dear Mr. Fender:

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 The general controls provisions of the Act 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. ನ್ನ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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.

{1}------------------------------------------------

Page 2 - Mr. Antony R. H. Fender

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) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. 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,

Celia M. Witten, Ph.D., M.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

FEB 6 1998

K974199

SECTION 2 - SUMMARY AND CERTIFICATION

510(k) Summary of Safety and Effectiveness

് This Summary of 810(k) 590 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.

Image /page/2/Picture/7 description: The image shows a sequence of six symbols. The first five symbols appear to be the number zero, each represented in a similar outlined style. The sixth symbol is a stylized image of a horse head, possibly representing a chess piece, rendered in solid black.

{3}------------------------------------------------

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.

. එ

1255

{4}------------------------------------------------

Image /page/4/Picture/10 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Rockville MD 20857

FEB 6 1998

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

Re : K974199 Acute Cardiac Ischemia Time-Intensive Predictive Instrument (ACI-TIPI) Option Requlatory Class: III (three) Product Code: 74 LOS November 7, 1997 Dated: 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (Q&) 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.

{5}------------------------------------------------

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/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

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

Enclosure

{6}------------------------------------------------

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:

ACI-TIP! is intended for adult patient populations.

M. Puye

510(k) Num

Regulation Number and Section

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).