MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION by GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN

The MARS Unity Workstation is intended to acquire, analyze, edit, review, report and store ambulatory and monitoring network ECG and multiparameter data. The MARS Unity Workstation is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital or clinic environment. Patient population includes both adult and pediatric.

The Heart Rate Variability (HRV) Option is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability heart rate data.

Heart Rate Variability (HRV) Option is intended to provide only HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

The HRV measurements produced by Heart Rate Variability (HRV) Option 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 judgement.

The HRV feature of this device has not been shown to be safe and effective for a specific clinical diagnosis.

Device Description

The Multi-Parameter Analysis and Review System (MARS) unity workstation is an off-the-shelf computer hardware platform that supports a number of software applications including Holter analysis and editing system software and full disclosure clinical review software.

The Holter analysis software performs acquisition, analysis, editing, review, reporting and storage of ambulatory ECG and multiparameter data acquired from solid-state electronic ECG recorders, tape recorders and the monitoring real-time network.
The clinical review software (CRS) is a full disclosure system that acquires ECG and mixed parameter waveform data from Marquette's Unity monitoring network for display and reporting.

Heart Rate Variability (HRV) Option is a software option for Marquette Holter analysis systems which measures the variation from one cardiac cycle to the next, utilizing specific morphology. Heart rate variability can be analyzed using either the Time Domain mode, which quantifies variations using simple statistics, or the Spectral mode, which characterizes interval variations as a power spectrum.

AI/ML Overview

The provided text describes the 510(k) summary for the MARS Unity Workstation with Heart Rate Variability (HRV) Option. However, it does not contain the acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Let's break down what information is available and what is missing, based on your requested points:

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

Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices rather than defining new performance acceptance criteria for quantitative metrics.
Reported Device Performance: Not explicitly stated in a quantitative manner. The document concludes that "MARS Unity Workstation with Heart Rate Variability (HRV) Option is as safe, as effective, and performs as well as the predicate devices," based on a "Test Summary" that lists quality assurance measures like risk analysis, requirements reviews, code inspections, and various types of testing, but no specific performance results (e.g., accuracy, sensitivity, specificity) are provided.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified.

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)

Not specified, as no formal "test set" and "ground truth establishment" study akin to typical AI/diagnostic device validation is described. The focus is on software development and testing rather than clinical study.

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

Not applicable/mentioned, as no formal "test set" and "ground truth establishment" study is described.

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

Not performed/mentioned. The device is an "option" for Holter analysis systems focusing on providing HRV measurements. It is explicitly stated that "Heart Rate Variability (HRV) Option is intended to provide only HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis." This indicates it's a measurement tool, not an AI-assisted diagnostic aid that human readers would "improve with."

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

The device is a "software option for Marquette Holter analysis systems which measures the variation from one cardiac cycle to the next." It is a standalone algorithm in the sense that it automatically calculates HRV measurements. However, the performance of this algorithm (e.g., accuracy of measurement compared to a gold standard) is not quantitatively reported in this document. The "Test Summary" mentions software testing, but not specific performance metrics.

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

Not explicitly specified. Since the device measures variation and does not diagnose, the ground truth would likely be a reference standard for heart rate variability measurements, but this is not detailed.

8. The sample size for the training set

Not applicable/specified. This appears to be a rule-based or statistical processing algorithm, not a machine learning model that requires a distinct "training set."

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

Not applicable, as there's no mention of a training set for a machine learning model.

Summary of what is present:

The document describes the MARS Unity Workstation with Heart Rate Variability (HRV) Option as a software update/addition to an existing Holter analysis system. Its purpose is to quantify heart rate variability (RR intervals) using Time Domain and Spectral modes.

The "Test Summary" section outlines the quality assurance measures applied during development, serving as the "study" for compliance and performance:

Risk analysis
Requirements specification reviews
Code inspections
Software and Hardware Testing
Safety testing
Environmental testing
Final validation

The conclusion states that "The results of these measures demonstrate MARS Unity Workstation with Heart Rate Variability (HRV) Option is as safe, as effective, and performs as well as the predicate devices, CENTRA IL Analysis System and Spacelabs Heart Rate Variability Software." This indicates that the predicate devices serve as the de facto "acceptance criteria" for overall safety and effectiveness, meaning the new device needed to perform comparably. However, no specific comparative performance data (e.g., exact agreement rates, correlation coefficients, or specific discrepancies) is provided in this summary.

This 510(k) summary represents a typical submission of its era, focusing on substantial equivalence through comparison to legally marketed predicate devices and robust software development processes, rather than a detailed clinical performance study with quantitative acceptance criteria and results for a novel AI/diagnostic algorithm.

Summary

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Section 2 Summary and Certification

2.1 510(k) Summary of Safety and Effectiveness

Date:	May 24, 1999
Submitter:	GE Marquette Medical Systems8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Laura L McComisCorporate Regulatory AffairsGE Marquette Medical SystemsPhone: (414) 362-2688Fax: (414) 355-3790
Device:	Trade Name:	MARS Unity Workstation with Heart Rate Variability (HRV) Option
Common/Usual Name:		Holter Analysis System
Classification Names:		Classification Name: Computer, Diagnostic, ProgrammableClassification Number: 74DQK
Predicate Devices:		K922171 CENTRA II Analysis SystemK950779 Spacelabs Heart Rate Variability Software Option
Device Description:		The Multi-Parameter Analysis and Review System (MARS) unityworkstation is an off-the-shelf computer hardware platform thatsupports a number of software applications including Holteranalysis and editing system software and full disclosure clinicalreview software.1) The Holter analysis software performs acquisition, analysis,editing, review, reporting and storage of ambulatory ECGand multiparameter data acquired from solid-state electronicECG recorders, tape recorders and the monitoring real-timenetwork.2) The clinical review software (CRS) is a full disclosure systemthat acquires ECG and mixed parameter waveform datafrom Marquette's Unity monitoring network for display andreporting.Heart Rate Variability (HRV) Option is a software option forMarquette Holter analysis systems which measures the variationfrom one cardiac cycle to the next, utilizing specific morphology.Heart rate variability can be analyzed using either the TimeDomain mode, which quantifies variations using simple statistics,or the Spectral mode, which characterizes interval variations asa power spectrum.
Intended Use:	The MARS Unity Workstation is intended to acquire, analyze, edit,review, report and store ambulatory and monitoring networkECG and multiparameter data. The MARS Unity Workstation isintended to be used by trained operators under the directsupervision of a licensed health care practitioner in a hospital orclinic environment. Patient population includes both adult andpediatric.The Heart Rate Variability (HRV) Option is intended to be used forthe analysis of the variability in RR intervals (heart rate) and toreport measurements of the variability heart rate data.Heart Rate Variability (HRV) Option is intended to provide onlyHRV measurements and is not intended to produce anyinterpretation of those measurements or any kind of diagnosis.The HRV measurements produced by Heart Rate Variability (HRV)Option are intended to be used by qualified personnel inevaluating the patient in conjunction with patient's clinicalhistory, symptoms, other diagnostic tests, as well as theprofessional's clinical judgement.The HRV feature of this device has not been shown to be safeand effective for a specific clinical diagnosis.
Technology:	MARS Unity Workstation with Heart Rate Variability (HRV) Optionemploys the same technology as the predicate devices.
Test Summary:	The MARS Unity Workstation with Heart Rate Variability (HRV)Option complies with voluntary standards as detailed in Section 9Specific Standards and Guidances of this submission. Thefollowing quality assurance measures were applied to thedevelopment of MARS Unity Workstation with Heart RateVariability (HRV) Option:Risk analysis Requirements specification reviews Code inspections Software and Hardware Testing Safety testing Environmental testing Final validation
Conclusion:	The results of these measures demonstrate MARS UnityWorkstation with Heart Rate Variability (HRV) Option is as safe, aseffective, and performs as well as the predicate devices, CENTRAIL Analysis System and Spacelabs Heart Rate Variability Software

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Option.

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Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 8 1999

Ms. Laura L. McCornis Regulatory Affairs Specialist GE Marquette Medical Systems 8200 W. Tower Avenue Milwaukee, WI 53223

K991786 Re: MARS Unity Workstation with Heart Rate Variability II (two) Requlatory Class: Product Code: DPS Dated: September 17, 1999 Received: September 20, 1999

Dear Ms. McCornis:

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 leqally 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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 requlation 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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Page 2 - Ms. Laura L. McCornis

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" (21CFR 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,

Nancy C. Brogdon for
Celia M. Witten, Ph.D., M.I

Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 11 Indications for Use Statement

510(k) Number (if known):

Unknown - 510(k) filed: May 24, 1999

Device Name: Option

MARS Unity Workstation with Heart Rate Variability (HRV)

Indications For Use:

The Heart Rate Variability (HRV) Option is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability heart rate data.

Heart Rate Variability (HRV) Option is intended to provide only HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

The HRV feature of this device has not been shown to be safe and effective for a specific clinical diagnosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/13 description: The image shows the words "Prescription Use" followed by "(Per 21 CFR 801.109)". There is a check mark above the line under the word "Use". The text is in a simple, sans-serif font.

Over-The-Counter Use_

(Optional Format 1-2-96)

Nancy C. Boydon

ascular, Resmiratory,

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).