GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices, including diagnostic 12-lead devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients' needs. The ECG module may be licensed to other software developers as an ECG viewer for their products. GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GEMS does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

Device Description

GEMS is a software product designed for Microsoft Windows 98, Windows NT, and Windows 2000 operating systems running on an IBM compatible platform. GEMS is compatible with industry standard client server database management systems and as such will operate standalone or on a local or wide area networks. GEMS consists of a user interface that enables health care professionals to input, store, and output data from a relational database. The product consists of a set of modules that can be installed as required to customize the application to individual users' needs. Modular design has the benefit of encapsulating changes within the overall application. If a module changes, then in most cases the change will affect only that module and will not affect the rest of the program. This permits more efficient and controlled development and testing, and prevents new and unknown safety issues and anomalies from being introduced. This stability contributes to the safety and reliability of the product. GEMS is capable of multi-tasking and supports the linking and embedding of related information objects in the ECG. The software stores all aspects of a patient's cardiology record including: arrhythmia diagnosis, pathological diagnosis, ECGs, ECG information, physician notes, clinical history, pacemaker/ICD data and associated reports. Data can be entered via keyboard, mouse, bar code reader, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed. GEMS is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

AI/ML Overview

The provided document describes the Global ECG Management System II (GEMS), a software product designed for managing ECG and patient cardiology data.

However, the document does not contain information about acceptance criteria, a study proving device performance against these criteria, or specific performance metrics (like sensitivity, specificity, or accuracy) derived from such studies.

The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Brentwood PC-ECG K955023) by detailing its intended use, description, and technological characteristics. The only specific performance testing mentioned is for the heart rate calculation feature, which was "completed and submitted according to the relevant sections of AAMI EC38." However, no results from this testing are provided in the document.

Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in the provided text.

Here's a breakdown of what CANNOT be answered based on the provided text:

A table of acceptance criteria and the reported device performance: Not available. The document states that testing for heart rate calculation was done according to AAMI EC38, but no specific criteria or performance results are disclosed.
Sample size used for the test set and the data provenance: Not available.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
Adjudication method for the test set: Not available.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not available. The device is described as a data management tool and specifically states it "does not offer diagnosis or medical alarms," and "It is intended that competent human intervention be involved before any impact on health occurs." This suggests it's not an AI-assisted diagnostic tool that would typically undergo MRMC studies for improved reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
The type of ground truth used: Not available.
The sample size for the training set: Not available.
How the ground truth for the training set was established: Not available.

The document primarily focuses on regulatory submission (510(k) summary and FDA clearance letter) and establishing substantial equivalence rather than detailing performance studies.

Summary

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APR 3 0 2002

Image /page/0/Picture/1 description: The image shows the logo for CardioComm Solutions Inc. The logo features a stylized heart shape above the company name. The heart shape is formed by two curved lines that meet at the bottom and top, creating a heart-like silhouette. Below the heart shape, the words "CARDIOCOMM" and "SOLUTIONS INC" are printed in a bold, sans-serif font.

11020366 01/2

Submitter

Name:	CardioComm Solutions Inc.
Address:	201 – 3060 Cedar Hill RoadVictoria, B.C., CanadaV8T 3J5
Phone:	(250) 744-1822
Fax:	(250) 744-1866
Contact:	Angela Halwas
Date:	January 30, 2002

510(k) SUMMARY

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.

The assigned 510(k) number is: K982384.

Device

Global ECG Management System II (GEMS) Name:

Brentwood PC-ECG (K955023) Substantial Equivalence is claimed to:

Description:

The product consists of a set of modules that can be installed as required to customize the application to individual users' needs. Modular design has the benefit of encapsulating changes within the overall application. If a module changes, then in most cases the change will affect only that module and will not affect the rest of the program. This permits more efficient and controlled development and testing, and prevents new and unknown safety issues and anomalies from being introduced. This stability contributes to the safety and reliability of the product.

GEMS is capable of multi-tasking and supports the linking and embedding of related information objects in the ECG. The software stores all aspects of a patient's cardiology record including: arrhythmia diagnosis, pathological

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GEMS (K982384) -- 510(k) Summary

diagnosis, ECGs, ECG information, physician notes, clinical history, pacemaker/ICD data and associated reports.

Data can be entered via keyboard, mouse, bar code reader, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed.

GEMS is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

Intended Use:

GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices, including diagnostic 12lead devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients' needs. The ECG module may be licensed to other software developers as an ECG viewer for their products. GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GEMS does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

Technological Characteristics:

Only one feature of GEMS cannot be found in the predicate device: heart rate calculation in software. Testing for calculation of heart rate in software has been completed and submitted according to the relevant sections of AAMI EC38.

All other features of GEMS are present in the predicate. GEMS is therefore substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2002

Ms. Angela Halwas Quality System Manager CardioComm Solutions, Inc. 201 - 3060 Cedar Hill Road Victoria, B.C., Canada V8T 3J5

Re: K020366

Trade Name: Global ECG Management System II (GEMS) Regulation Name: Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulatory Class: Class II (two) Product Code: 74 DPS Dated: January 31, 2002 Received: February 4, 2002

Dear Ms. Halwas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Angela Halwas

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dri brisaantes vour device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any 1 coolar bakated that egirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT rat 6077, idoomig (DI CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough finding of substantial equivalence of your device to a legally premainst notification " 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of ICP article of the stime on the promotion and advertising of Compliance at (301) 594-4639 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regaration on information on your responsibilities under the Act may be obtained from the Oiner general miormation on your nernational and Consumer 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,

V. Craig Tiller, Ph.D.

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

KOZO368 510(k) Number (if known):

Global ECG Management System (GEMS) Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020362

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

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).