The new device is a modification to previously reviewed submittals containing the EASI algorithm. The modification is a software-based change that slightly improves existing correlation coefficients. The modification also allows reconstruction to simulate a Mason Likar lead placement.

AI/ML Overview

Acceptance Criteria and Device Performance

Metric	Acceptance Criteria (Explicit or Implied)	Reported Device Performance
Correlation Coefficients	The modified coefficients should not show a decreased correlation in any of the leads compared to traditional 12-Lead ECG and Mason Likar 12-Lead ECG.	The modified coefficients did not show a decreased correlation in any of the leads. Several of the leads showed improvements, with the improvement in the correlation coefficient varying from 0 to 0.10 in one case.
Patient Risk	The modification should not increase patient risk relative to what is on the market today.	"It was therefore concluded that the modification does not increase patient risk relative to what is on the market today. It does improve effectiveness in some of the leads based on the data gathered." This suggests that maintaining or improving effectiveness without increasing risk was the implied acceptance criterion.

Study Information:

Sample size used for the test set and the data provenance: Not explicitly stated but the text mentions "earlier studies on the same patients" when discussing the comparison of correlation coefficients, implying a retrospective analysis of existing data. The number of patients in these "earlier studies" is not specified. The country of origin of the data is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "2 physician over-reads" were involved in comparing the modified coefficients to traditional 12-Lead ECG and Mason Likar 12-Lead ECG. Their specific qualifications are not detailed beyond "physician."
Adjudication method for the test set: Not explicitly stated. The text mentions "2 physician over-reads comparing the modified coefficients," but does not clarify if there was a formal adjudication process if the physicians disagreed.
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 was not a comparative effectiveness study involving human readers. The study focused on the performance of the algorithm itself in terms of correlation coefficients.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the study primarily evaluated the standalone performance of the algorithm's modified coefficients by comparing them to established ECG standards. The "2 physician over-reads" serve as a form of validation against human interpretation of established methods, but the core performance metric (correlation coefficient) is algorithmic.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth was established by "traditional 12 Lead ECG and Mason Likar 12 Lead ECG" which were then reviewed by "2 physician over-reads." This implies a form of expert consensus based on established clinical methods.
The sample size for the training set: Not specified. The document only refers to "earlier studies on the same patients" for validation, without detailing a separate training set.
How the ground truth for the training set was established: Not specified, as details about a distinct training set are absent. It can be inferred that the ground truth for any underlying algorithm development would have been established using similar methods (traditional ECGs and expert interpretation) as those used for validation.

Summary

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K020456
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9 2002 JUL

SMDA/510(k) Summary:

510(k) Summary 30 January 2002

This 510(k) summary for safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 8807.92.

1. The submitter of this premarket notification is:
  Paul Schrader Quality and Regulatory Manager Philips Medical Systems 3000 Minuteman Road, Andover, MA 01810-1085 978 659 2404 Fax: 978 659 7360 Tel:
Unique Identifier for Submittal: EASI 12 Lead Algorithm / Coefficients 2.

	14/11/2017
000 00000------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	The Trans	electrocardiographead switching.

1. The new device is a modification to previously reviewed submittals containing the EASI algorithm.
The modification is a software-based change that slightly improves existing 4. correlation coefficients. The modification also allows reconstruction to simulate a Mason Likar lead placement.
The new device has the same technological characteristics as the legally marketed న. predicate device.
Verification, validation, and testing activities establish the performance, 6. functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved 2 physician over-reads comparing the modified coefficients to traditional 12 Lead ECG and Mason Likar 12 Lead ECG on the same patients. A comparison of the correlation coefficients from earlier studies on the same patients was done. The modified coefficients did not show a decreased correlation in any of the leads. Several of the leads showed improvements with the improvement in the correlation coefficient varying from 0 to 0.10 in one case. It was therefore concluded that the modification does not increase patient risk relative to what is on the market today. It does improve effectiveness in some of the leads based on the data gathered.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2002 புரட

Phillins Medical System c/o Mr. Paul M. Schrader Q&R Manger Cardiology Division 3000 Minuteman Road Andover, MA 01810-1085

Re: K020456
Device Name: EASI 12 LEAD TM 12 Lead Coefficients Regulation Number: 21 CFR 870.2350 Regulation Name: Adapter, Lead Switching, ECG Regulatory Class: Class II (two) Product Code: 74DRW Dated: February 7, 2002 Received: February 11, 2002

Dear Mr. Schrader:

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 vour 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.

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

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Page 2 - Mr. Paul M. Schrader

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 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 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.

Roark Till

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

Enclosure

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Indications for Use Statement

510(k) Number: K020456 EASI 12 LEAD™ 12 Lead Coefficients Device Name:

Indications for Use:

Assessment of real time ST segment analysis in adult patients. Assessment is indicated for the hospital environment.

Note to Users on Patient Population:

Based on the FDA review of K992595 the following labeling must be disclosed within user documentation for EASI 12 LEAD ST Analysis:
Assessment of EASI 12 LEAD derived 12-lead ST measurements is recommended for adult patients that meet the following parameters:
. Ages 33 to 82 years
Heights: 147 to 185 cm (58 to 73 in) .
Weights: 53 to 118 kg (117 to 261 lbs.) .
Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb.) .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHI R PAGE 11 NI (1 SS (R) 1

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	X
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OR over-the-counter Use

(Division Sign-Off)
Division of Cardiovascularand Respiratory Devices

510(k) Number	K020456
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Regulation Number and Section

§ 870.2350 Electrocardiograph lead switching adaptor.

(a)
Identification. An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations such as leads I, II, and III.(b)
Classification. Class II (performance standards).