QT Guard Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECG for obtaining the measurements of QT interval dispersion and T wave complexity.

QT-Guard Analysis Program is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurements or diagnosis.

The QT dispersion and T wave complexity measurements produced by QT Guard Analysis System are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment.

QT Guard Analysis System is intended for adult patient populations.

Device Description

QT Guard Analysis System is a software program for measuring the QT interval dispersion and T wave complexity from simultaneously acquired 12-lead ECG.

AI/ML Overview

The provided text is a 510(k) summary for the "QT Dispersion and T wave Analysis System (QT Guard Analysis System)". It states that the device is substantially equivalent to a predicate device, the Marquette 12SL Analysis Program, based on quality assurance measures and laboratory tests. However, it does not provide detailed acceptance criteria or a comprehensive study report with specific performance metrics as requested.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided text. The submission focuses on substantial equivalence to a predicate device rather than specific quantitative performance thresholds.	The device performs "as well as the predicate device, Marquette 12SL analysis program" in terms of safety and effectiveness, based on quality assurance measures, software testing, and laboratory tests.

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

The document does not specify a sample size for a test set or the data provenance. It mentions "laboratory tests" but does not elaborate on their methodology or the data used.

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. The comparison is made against a predicate device, and it's not clear how "ground truth" was established for any internal testing, if any such concept was even applied in a formal way beyond comparing outputs to the predicate.

4. Adjudication method for the test set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or implied. The device is for analysis of ECGs to provide measurements, not for assisting human readers in interpretation or diagnosis.

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

Yes, the testing described appears to be a standalone assessment of the algorithm's performance. The statement "The results of these measurements demonstrated that QT Guard analysis is as safe, as effective, and performs as well as the predicate device" refers to the system itself, without human intervention in its primary function of generating measurements.

7. The type of ground truth used

The concept of "ground truth" in the typical sense (e.g., pathology, outcomes data, or expert consensus on clinical diagnoses) is not directly applicable or explicitly stated in the context of this submission. The device provides measurements of QT interval dispersion and T wave complexity. The "truth" in this context would likely be the correctness and consistency of these measurements when compared to the predicate device, or possibly to known physiological standards, though the latter is not detailed. The submission relies on comparison to a predicate device (Marquette 12SL Analysis Program) as the basis for establishing substantial equivalence for its performance.

8. The sample size for the training set

The document does not specify a training set or its sample size. As a 510(k) submission for substantial equivalence, the focus is on demonstrating similar performance to an existing device, rather than detailing the development and training of a new AI model in the contemporary sense.

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

This information is not provided, as a training set is not discussed.

Summary

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OCT 6 1998

K981024

SECTION 2 - SUMMARY AND CERTIFICATION

2.1 510(k) Summary of Safety and Effectiveness

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 Systems8200 W. Tower AvenueMilwaukee, WI 53223Telephone: (414) 355-5000FAX: (414) 362-3553
Contact Person:	Kristin Pabst
Device:	Trade Name: QT Dispersion and T wave AnalysisSystem (QT Guard Analysis System)Classification Name: Computer, diagnostic, programmable
Predicate Device:	Marquette 12SL Analysis Program
Device Description:	QT Guard Analysis System is a software program formeasuring the QT interval dispersion and T wave complexity fromsimultaneously acquired 12-lead ECG.
Intended Use:	QT Guard Analysis System is intended to be used in a hospitalor clinic environment by competent health professionals
	♦ QT Guard Analysis System is intended to perform the analysisof simultaneously acquired 12-lead ECG for obtaining themeasurements of QT interval dispersion and T wave complexity.
	♦ QT-Guard Analysis System is intended to provide only themeasurements of the QT dispersion and T wave complexity and itis not intended to produce any interpretation of thosemeasurements or diagnosis.
	♦ The QT dispersion & T wave complexity measurementsproduced by QT-Guard Analysis System are intended tobe used by qualified personnel in evaluating the patient inconjunction with patient's clinical history, symptoms, otherdiagnostic tests, as well as the professional's clinical judgment.
	♦ QT Guard Analysis System is intended for adult patientpopulations.
Technology:	QT Guard Analysis System employs technology similar to thatused in the predicate device.

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Performance:

The following quality assurance measures were applied: to the development of PHi-Res analysis. Requirements specification reviews, code inspections, software testing and laboratory tests of the QT Guard analysis.

The results of these measurements demonstrated that QT Guard analysis is as safe, as effective, and performs as well as the predicate device, Marquette 12SL analysis program.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 1998

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

Re : K981024 QT Dispersion and T Wave Analysis Program (QT-Guard Analysis System) Regulatory Class: III (three) Product Code: 74 LOS July 15, 1998 Dated: Received: July 16, 1998

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 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, 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 TPDA 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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Page 2 - Ms. Kristin Pabst

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 requlation 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. 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

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K981024

SECTION 11 - INTENDED USE STATEMENT

510(k) Number (if known): Unknown - 510(k) filed March 18, 1998

Device Name: QT Dispersion and T wave Analysis Program (QT Guard Analysis System)

Indications For Use:

QT Guard Analysis System is intended to be used in a hospital or clinic environment by competent health professionals.

QT Guard Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECG for obtaining the measurements of QT interval dispersion and T wave complexity.

QT-Guard Analysis Program is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurements or diagnosis.

QT Guard Analysis System is intended for adult patient populations.

Rucuptim Use ✓

Mark Krainer

(Division Sign-Off)
Division of Cardiovascular, Respiratory,

and Neurological Devices

510(k) Number __

Regulation Number and Section

N/A