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 qivers 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 djagnosis 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.

This version of GEMS includes the EASI algorithm for deriving an approximation to a 12-lead ECG from a 3-channel recording (using the lead placement specified in the EASITrak 12 Model 4100 / Zymed Model 4100 / EASI Arrhythmia Event Monitor user manual). If manual ST segment measurements will be made on the approximated 12-lead ECG, the patient population is limited to the following indications:

Ages: 33 to 82 years Heights: 147 to 185 cm (58 to 73 in) Weights: 53 to 118 kg (117 to 261 lb)

Height to Weight ratios: 1.41 to 2.99 cm/kq (0.25 to 0.54 in/lb)

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 text describes the Global ECG Management System (GEMS), focusing on a new feature: the EASI algorithm for deriving an approximated 12-lead ECG from a 3-channel recording.

However, the document does not contain a study that uses acceptance criteria to prove the device meets these criteria. Instead, it describes the device's functionality, its intended use, and its technological characteristics, particularly the EASI feature. There is a mention of the EASI system providing an "alternative source for 12-Lead ECGs, which are already supported by the approved (unmodified) device," implying a comparison to an existing, approved method rather than a full performance study against defined acceptance criteria.

The submission is a 510(k) for substantial equivalence, which means it likely relies on demonstrating that the new feature is as safe and effective as a legally marketed predicate device, rather than providing extensive performance data against predefined benchmarks for the new feature in isolation.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text.

Based on the provided text, the following can be inferred:

Device: Global ECG Management System (GEMS)
New Feature: EASI algorithm for deriving an approximation to a 12-Lead ECG from a 3-channel ECG.
Context: This is a 510(k) submission for substantial equivalence.

Given the information provided, I cannot complete the table or thoroughly answer the questions about acceptance criteria and study details. The document is a 510(k) summary focused on demonstrating substantial equivalence rather than a detailed clinical validation study report for performance metrics.

Here's what can be extracted, emphasizing the lack of detailed study information:

A table of acceptance criteria and the reported device performance:
- No specific acceptance criteria or detailed performance metrics for the EASI algorithm are provided in this summary. The document states, "The EASI feature only supplies an alternative source for 12-Lead ECGs, which are already supported by the approved (unmodified) device. Thus the modification represents a minor change to the functionality of the product and does not change the indications for use." This implies the acceptance criterion was likely demonstrating that it functioned as an "alternative source" consistent with the predicate, rather than precise diagnostic performance targets.
- The only performance-related information given is for a specific scenario: "If manual ST segment measurements will be made on the approximated 12-lead ECG, the patient population is limited to the following indications: Ages: 33 to 82 years, Heights: 147 to 185 cm (58 to 73 in), Weights: 53 to 118 kg (117 to 261 lb), Height to Weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)". This is a limitation for use, not a performance metric or acceptance criterion.
Sample sizes used for the test set and the data provenance:
- Not specified. The document does not describe a performance study with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. No detailed performance study or ground truth establishment process is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. No detailed performance study is described.
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:
- No. The document does not describe an MRMC study. GEMS is described as a "data management tool" and "does not offer diagnosis or medical alarms," implying it's not an AI-assisted diagnostic tool for Human-in-the-loop performance improvement. Clinical judgment and experience are intended to be used to check and interpret the data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly described as a standalone performance study with metrics. The document frames the EASI algorithm as an "alternative source" for ECG data which GEMS then manages. There are no reported standalone performance metrics like sensitivity, specificity, or accuracy for the EASI algorithm itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not specified. No detailed performance study is described that would require ground truth establishment.
The sample size for the training set:
- Not specified. No mention of a training set as this is not a study report.
How the ground truth for the training set was established:
- Not applicable / Not specified. No mention of a training set or ground truth establishment.

Summary

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P-1/2

KO22297

SEP 2 7 2002

510(k) Summary

Submitted in accordance with the requirements of 21 CFR 807.92.

Assigned 510(k) number: K022297.

Submitter

Name:	CardioComm Solutions Inc.
Address:	201 - 3060 Cedar Hill Road
	Victoria, B.C., Canada
	V8T 3J5
Phone:	(250) 744-1822
Fax:	(250) 744-1866
Contact:	Angela Halwas
Date:	July 15, 2002

Device

Global ECG Management System (GEMS) Name: Substantial Equivalence is claimed to: GEMS (K982384 and K020366)

Description

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

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

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 in this modified version of GEMS cannot be found in the predicate device (unmodified version of GEMS); the EASI system for deriving an approximation to a 12-Lead ECG from a 3-channel ECG. The EASI feature only supplies an alternative source for 12-Lead ECGs, which are already supported by the approved (unmodified) device. Thus the modification represents a minor change to the functionality of the product and does not change the indications for use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with three curved lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 7 2002

CardioComm Solutions Inc. c/o Ms. Angela Halwas Ouality System Manager 201-3060 Cedar Hill Road Victoria, British Columbia CANADA V8T 3J5

Re: K022297

Trade Name: Global ECG Management System II (GEMS) Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: DSH Dated: August 27, 2002 Received: August 30, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

l. Oa. Tech

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use

510(k) Number: K022297

Device Classification Name: Mercator

Device Proprietary Name: GEMS

Indications for use:

Ages: 33 to 82 years Heights: 147 to 185 cm (58 to 73 in) Weights: 53 to 118 kg (117 to 261 lb)

Height to Weight ratios: 1.41 to 2.99 cm/kq (0.25 to 0.54 in/lb)

Prescription Use K

(Division Sign-Off)
Division of Cardiovascular
and Respiratory Devices

ber K022247

Printed: 9/24/2002 CONFIDENTIAL

GEMS Special 510(k) Submission (K022297) Page 10 Amendment 1 CardioComm Solutions

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).