Mercator is intended to be used as a data management tool for physicians and cardiac clinics to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG 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. Mercator is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. Mercator does not offer diagnosis or medical alarms.

Device Description

Mercator is a software product designed for the Microsoft Windows 95 and Microsoft Windows NT operating systems running on an IBM compatible platform. Mercator 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 "plugged in" to customize the application to individual users' needs.

Mercator is capable of multi-tasking and supports the linking and embedding of related information objects in the ECG. The software supports many aspects of a patient's cardiology record including: arrhythmia diagnosis, pathological diagnosis, ECGs, ECG information, doctor notes, pacemaker/ICD data and associated reports. Mercator also supports appointment scheduling and stores information on physicians, facilities, allied health care professionals, and insurance providers.

Mercator 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 Mercator 510(k) summary does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner. The document focuses on regulatory submission requirements for substantial equivalence.

Here's a breakdown of the available information and what's missing, based on your requested headings:

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

Acceptance Criteria	Reported Device Performance
Software Functionality	"All software modules were tested at multiple levels including the unit level, post integration, and system level. All modules are tested thoroughly for proper functionality by trained staff using proven techniques. Testing included a combination of manual and automated test suites."
Applicability to ANSI/AAMI EC38 - 1994 Standard	"the ECG module was tested against the applicable sections of the ANSI/AAMI EC38 - 1994 Standard for Ambulatory Electrocardiographs concerned with effectiveness and safety."
Safety and Reliability	"Testing results indicated that the product is safe and reliable. All test plans were passed in accordance with the Mercator Product Release Test Plan."

Missing:

Specific, quantifiable acceptance criteria (e.g., "Software shall perform X with Y% accuracy" or "System uptime shall be Z%").
Quantitative performance metrics and results against those criteria. The statements are qualitative ("thoroughly," "proper functionality," "safe and reliable").

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: Not specified. The document mentions testing "all software modules" and "the ECG module," but does not provide details on the specific data sets or number of test cases used.
Data Provenance: Not specified. Given the nature of the device (ECG data management software), the "test set" would likely refer to the data used during software testing, not patient data for clinical evaluation. The document primarily discusses software functionality and compliance with a standard, not clinical performance with patient data.

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 applicable. The "ground truth" concept, as typically applied to performance evaluation with expert adjudication, is not relevant here. The testing described is primarily focused on software functionality, adherence to design specifications, and compliance with a technical standard (ANSI/AAMI EC38 - 1994), not diagnostic accuracy against a clinical ground truth.

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

Not applicable. As noted above, the testing is for software functionality and technical standard compliance, not clinical diagnostic accuracy requiring adjudicated ground truth.

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

No. This is not mentioned. The Mercator is described as a "data management tool" and explicitly states, "Mercator does not offer diagnosis or medical alarms." Therefore, an MRMC study comparing human reader performance with and without AI assistance isOutside the scope of its intended use.

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

No. This is not applicable, as Mercator is a data management tool, not an algorithm providing a diagnostic output. The document explicitly states, "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."

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

Not applicable. The "ground truth" in the context of Mercator's testing would be verifying that the software performed its intended functions (e.g., storing, retrieving, displaying ECG data correctly) according to its design specifications and the relevant technical standard. This is not a clinical ground truth regarding disease state.

8. The sample size for the training set

Not applicable. Mercator is a data management software, not a machine learning or AI-driven diagnostic device that would require a "training set" in the conventional sense.

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

Not applicable, as there is no mention of a training set for Mercator.

Summary of Device Evaluation in the 510(k) document:

The 510(k) submission for Mercator primarily focuses on demonstrating substantial equivalence to predicate devices by comparing technological characteristics and showing compliance with relevant software development and testing practices. The "Performance Testing and Conclusions" section states that:

All software modules underwent multi-level testing (unit, integration, system) by trained staff using manual and automated test suites.
The ECG module was tested against "applicable sections of the ANSI/AAMI EC38 - 1994 Standard for Ambulatory Electrocardiographs concerned with effectiveness and safety."
The results indicated the product is "safe and reliable" and "All test plans were passed in accordance with the Mercator Product Release Test Plan."

This type of documentation is typical for software products of this era (1998) that act as data management tools rather than advanced diagnostic or AI-powered devices. The focus is on demonstrating that the software functions as designed and meets recognized industry standards for medical devices of its class. The absence of detailed clinical performance data, expert adjudication, or AI-specific evaluation metrics is consistent with its intended use as a data management tool, not a diagnostic aid.

Summary

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K982384

Mercator 510(k) Summary

Submitter:

Harley Street Software 771 Vanalman Avenue Victoria, BC Canada V8Z 3B8 Tel: (250) 744-1822 Fax: (250) 744-1866

Contact Person: Adrian Somers Date Prepared: May 29, 1998 Device Common Name: Electrocardiograph Device Trade/Proprietary Name: Mercator Classification Panel: Cardiovascular

Possible Device Classification Names:

870.2340 Electrocardiograph 870.2450 Medical Cathode-Ray Tube Display 870.1425 Programmable Diagnostic Computer

Predicate Devices:

Cardiomagic Concerto 2000 (K964036) Synergy (K964784) Paceart CPTS-86/12 (K915632)

Device Description

The product consists of a set of modules that can be "plugged in" to customize the application to individual users' needs.

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Intended Use of Device

Summary of Technological Characteristics Comparison with Predicate Devices

Both Mercator and its predicates are software databases that allow professionals to receive, store, and display electrocardiographs (ECG) recorded from patients by external monitoring devices such as event recorders. All are run on the industry standard IBM compatible platform using industry standard off-the-shelf Microsoft databases. All allow for editing and printing of patient reports that include ECG information and patient demographics. All features of Mercator are present in one or more of the predicates, except the ability to communicate with the ECG recording/transmitting device through an Infra-red data acquisition serial channel (IrDA port), and the ability of the software to automatically answer and receive remote ECG data downloads via modem. IrDA poses the same questions of effectiveness and efficacy as a serial cable, but serves to isolate the patient from any source of electrical shock potential from the PC/computer. Auto-answer has no adverse effect on effectiveness or safety and is aimed solely at satisfying user preferences.

Performance Testing and Conclusions

All software modules were tested at multiple levels including the unit level, post integration, and system level. All modules are tested thoroughly for proper functionality by trained staff using proven techniques. Testing included a combination of manual and automated test suites.

In addition to the above non-clinical testing, the ECG module was tested against the applicable sections of the ANSI/AAMI EC38 - 1994 Standard for Ambulatory Electrocardiographs concerned with effectiveness and safety.

Testing results indicated that the product is safe and reliable. All test plans were passed in accordance with the Mercator Product Release Test Plan.

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Image /page/2/Picture/0 description: The image shows the logo for Harley Street Software. The logo consists of a black square with the letters "HSI" stacked on top of each other in white. Below the square is the text "HarleyStreet Software" in a serif font, with the registered trademark symbol next to the word "Software".

Truthful and Accurate Statement

[As required by 21 CFR 807.87(j)]

I certify that, in my capacity as Quality Assurance and Regulatory Affairs Coordinator of Harley Street Software Ltd., I believe to the best of my knowledge that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

Bune Webster

(Signature)

Bruce Webster

(Typed Name)

July 7/98

(Dated)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid with three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 1999

Mr. Craig Person CardioComm Solutions, Inc. 771 Vanalman Avenue Victoria, BC Canada V8Z 3B8

Re: K982384 Mercator ECG Database Software Requlatory Class: II (two) Product Code: DSH October 30, 1998 Dated: November 3, 1998 Received:

Dear Mr. Person:

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 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, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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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.

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, ² Misbranding by reference to premarket notification² (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,

Thomas J. Callahan

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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Page 1 of 2

510(k) Number (if known): K982384

Device Name: Mercator

Indications For Use:

Mercator is intended to be used as a data management tool for physicians and cardiac clinics to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including Holter and Event Recorder 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. Mercator is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. Mercator does not offer diagnosis or medical alarms.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Valla Hill

Respiratory,
Number KA982384

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Prescription Use X
(Per 21 CFR 801.109)

Over-The-Counter Use____

(Optional Format 1-2-96)

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).