The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12lead ECGs for rhythm and contour information by providing an initial automated interpretation. The interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.

The ACS Tool option is intended for adult patient populations who are suspected clinically to have acute coronary syndrome.

Device Description

The 12SL ECG Analysis Program is a software only algorithm

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the GE 12SL ECG Analysis Program, based on the provided document:

This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria for performance. Instead, it states that "The subject of this premarket submission, 12SL ECG Analysis Program, did not require clinical studies to support substantial equivalence." This means the device's equivalence to a legally marketed predicate device (12SL ECG Analysis Program K#092369) was established through non-clinical tests and the assertion that it employs the "same functional scientific technology."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported device performance, or details of a study proving the device meets those criteria, as such information is explicitly stated as not required and thus not present in the provided text.

However, I can extract information related to the non-clinical tests and general compliance:

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

Not applicable. The document explicitly states: "The subject of this premarket submission, 12SL ECG Analysis Program, did not require clinical studies to support substantial equivalence." Therefore, no specific performance acceptance criteria or reported device performance from a clinical study are detailed. Non-clinical tests focused on compliance with standards.

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

Not applicable. No clinical test set was used or described.

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. No clinical test set or ground truth established by experts is mentioned for this submission.

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

Not applicable. No clinical test set or adjudication method is mentioned.

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, an MRMC comparative effectiveness study was not done. The document states no clinical studies were required.

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

Not applicable. No standalone performance study is explicitly described. The device "assists the physician" and the interpretation "may then be confirmed, edited, or deleted by the physician," indicating it's intended for human-in-the-loop use.

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

Not applicable. No ground truth for algorithm performance is described as no clinical studies were conducted for this premarket submission.

8. The sample size for the training set

Not applicable. The document does not provide details on the training set for the algorithm, as it primarily focuses on demonstrating substantial equivalence to a predicate device via non-clinical testing and shared technology.

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

Not applicable. The document does not provide details on how the ground truth for any training set might have been established.

Summary of Non-Clinical Tests and Compliance:

The device's substantial equivalence was supported by non-clinical tests demonstrating compliance with:

IEC 60601-2-25:2011 Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs - Edition 2.0
Relevant Guidances and/or Special Controls detailed in Section 9 of the premarket submission (details not provided in the excerpt).

Quality Assurance Measures Applied to Development:

Requirements Reviews
Risk Analysis
Software Verification and Validation
Performance testing (presumably non-clinical, related to compliance with standards)

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 5, 2015

GE Medical Systems Information Technologies, Inc. Kristin Pabst Regulatory Affairs Manager 9900 West Innovation Drive Wauwatosa, Wisconsin 53226

Re: K141963

Trade/Device Name: 12SL ECG Analysis Program Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX

Dated: January 29, 2015 Received: February 2, 2015

Dear Kristin Pabst,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

For 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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GE Healthcare

510(k) Premarket Notification Submission

510(k) Number:

Device Name: 12SL ECG Analysis Program

Indications for Use:

The ACS Tool option is intended for adult patient populations who are suspected clinically to have acute coronary syndrome.

Prescription Use_ X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background. The logo is simple, recognizable, and represents the multinational conglomerate corporation.

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	July 17, 2014
Submitter:	GE Medical Systems Information Technologies9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Kristin PabstRegulatory Affairs ManagerGE Medical Systems Information TechnologiesPhone: (414) 721-3104Fax: (414) 721-3863
Secondary Contact Person:	Doug KentzRegulatory AffairsGE Medical Systems Information TechnologiesPhone (414) 362-2038FAX: (414) 362-2585
Device: Trade Name:	12SL ECG Analysis Program
Common/Usual Name:	ECG Analysis Program
Classification Names:	Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Product Code:	MHX 21CFR 870.1025
Predicate Device(s):	12SL ECG Analysis Program K#092369
Device Description:	The 12SL ECG Analysis Program is a software only algorithm
Intended Use:	The 12SL ECG Analysis Program assists the physician in measuringand interpreting resting 12-lead ECGs for rhythm and contourinformation by providing an initial automated interpretation. Theinterpretation by the analysis program may then be confirmed, edited,or deleted by the physician. The analysis program is intended for usein the general population ranging from healthy subjects to patients withcardiac and/or non-cardiac abnormalities. The analysis program isintended for use in hospitals, outpatient clinics, emergencydepartments, and out-of hospital sites such as ambulances andpatients' homes.The ACS Tool option is intended for adult patient populations who aresuspected clinically to have acute coronary syndrome.
Technology:	The 12SL ECG Analysis Program employs the same functionalscientific technology as its predicate device. 12SL ECG AnalysisProgram (K092369).
Determination of SubstantialEquivalence:	Summary of Non-Clinical Tests:The 12SL ECG Analysis program was designed and tested forcompliance with applicable clauses of the following voluntary standard:

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GE Healthcare

510(k) Premarket Notification Submission

. IEC 60601-2-25:2011Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs - Edition 2.0
The 12SL ECG Analysis Program and its applications comply with the Guidances and/or Special Controls as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:
Requirements Reviews
o Risk Analysis
Software Verification and Validation .
. Performance testing

Summary of Clinical Tests:

The subject of this premarket submission, 12SL ECG Analysis Program, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the 12SL ECG Analysis Program to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.