The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, and the interpretation by the analysis program may then be confirmed, edited by the physician. The program is intended for use by qualified healthcare professionals and other healthcare facilities for the assessment of common cardiac abnormalities, including arthythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. They are offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

The AI-ECG Platform is qualified for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.

The AI-ECG Platform is used with compatible resting ECG devices which can export ECG recordings in Carewell ECG, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid.

Device Description

The AI-ECG Platform (S Edition) is a software package which is a distributed ECG auto analysis system designed to assist physician in measuring and interpreting 12-lead resting ECG with AI algorithm, the interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities, including arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

The Carewell AI-ECG Platform is intended to be used in conjunction with Carewell ECG device or compatible ECG can export Carewell proprietary ECG data, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid. The program receives ECG waveform data direct from device or user manually uploaded, analyzes ECG data and automatically interprets on the computer server, the ECG measurement, interpretation and waveform data are then downloaded to a PC based physician's diagnosis client application to allow physician review, modify and confirm the analysis statements, and print the report. The original ECG waveform data is stored permanently in the server computer securely.

AI/ML Overview

While the provided text describes the AI-ECG Platform and its substantial equivalence to predicate devices, it does not contain the detailed information required for an acceptance criteria table and the specific study proving the device meets those criteria, as outlined in the request.

The document primarily focuses on regulatory approval (510(k) submission), product description, and a high-level comparison to predicate devices, discussing:

Indications for Use: The intended purpose of the device.
Device Description: How the software functions.
Comparison to Predicates: Highlighting similarities in product codes, regulations, classification, and fundamental technology.
Non-Clinical Test Conclusion: Mentioning compliance with standards like AAMI ANSI EC57 for performance results and IEC 60601-2-25 for safety.

However, the document is missing specific performance metrics and the detailed study design elements you requested, such as:

A table of acceptance criteria with reported device performance: While AAMI ANSI EC57 is mentioned for performance, the actual criteria (e.g., sensitivity, specificity for specific cardiac abnormalities) and the results achieved are not provided.
Sample size and data provenance for the test set.
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
Details of any MRMC comparative effectiveness study, including effect size.
Standalone (algorithm-only) performance metrics.
The specific type of ground truth used (e.g., expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Without this specific information in the provided text, I cannot construct the requested table or describe the study in detail. The document states that "Bench test were conducted to verify that the subject device met all design specifications," but it does not elaborate on these specifications or the results of these tests in a quantifiable manner relevant to acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 19, 2018

Shenzhen Carewell Electronics., Ltd % Arthur Goddard President FDA Regulatory and Quality Systems Consultant 31853 Cedar Road Mayfield Heights, Ohio 44124-4445

Re: K180432

Trade/Device Name: AI-ECG Platform Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DPS Dated: September 27, 2018 Received: October 3, 2018

Dear Arthur Goddard:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Arielle Drummond -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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Indications for Use

510(k) Number (if known) K180432

Device Name AI-ECG Platform

Indications for Use (Describe)

The AI-ECG Platform is qualified for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image contains the logo for Carewell Health Care. The logo features a circular graphic on the left, composed of multiple pink horizontal lines. To the right of the graphic is the company name, "carewell," in a bold, dark blue font. Below "carewell" is the text "health care" in a smaller, lighter font, also in blue.

Section 5: 510(K) Summary

This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1900 and 21 CFR 807.92.

The assigned 510(K) Number: K180432

5. 510(K) Summary

Date of Preparation: Feb., 12th, 2018 5.1.

5.2. Sponsor

Shenzhen Carewell Electronics Co., Ltd. Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District 518055, Shenzhen, P.R. China Establishment Registration Number: 3010089768 Contact Person: Chang Liu Position: General Manager Tel: +86-755-86170389 Fax: +86-755-86170478 Email: standard@carewell.com.cn

Submission Correspondent 5.3.

Mr. Arthur Goddard 31853 Cedar Road, Ohio, 44124-4445, U.S.A. Tel: (216) 233-5722 Email: asjgoddard@aol.com

5.4. Subject Device Identification

Subject Device Name: AI-ECG Platform Edition: S Edition Common name: ECG Analysis Software Classification Name(s): Programmable Diagnostic Computer / Electrocardiograph Product Code: DQK, DPS Regulation Number: 21 CFR 870.1425 Review Panel: Cardiovascular Classification: II

5.5. Predicate Devices

510(k) Number: K113485 (Secondary) Device Name: Electrocardiograph

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Image /page/4/Picture/0 description: The image contains the logo for Carewell Health Care. The logo consists of a circular graphic on the left, made up of several pink horizontal lines. To the right of the graphic is the company name, "carewell", in a dark blue, sans-serif font. Below the company name are the words "health care" in a smaller, lighter font.

Shenzhen Carewell Electronics Co., Ltd.

Manufacturer: Shenzhen Carewell Electronics Co., Ltd.

510(k) Number: K052883 (Primary) Device Name: Datrix CardioServer ECG Management System Manufacturer: Datrix, Inc

5.6. Indications for use:

The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, and the interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities, including arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. They are offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.

The AI-ECG Platform is qualified for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.

The AI-ECG Platform is used with compatible resting ECG devices which can export ECG recordings in Carewell ECG, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using nonstandard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid.

5.7. Device Description

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Image /page/5/Picture/0 description: The image contains the logo for Carewell Health Care. The logo consists of a circular design on the left, made up of several horizontal lines. To the right of the design is the word "carewell" in a dark blue, sans-serif font. Below "carewell" are the words "health care" in a smaller, lighter font.

Shenzhen Carewell Electronics Co., Ltd.

manually uploaded, analyzes ECG data and automatically interprets on the computer server, the ECG measurement, interpretation and waveform data are then downloaded to a PC based physician's diagnosis client application to allow physician review, modify and confirm the analysis statements, and print the report. The original ECG waveform data is stored permanently in the server computer securely.

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Image /page/6/Picture/0 description: The image shows the logo for Carewell health care. The logo consists of a pink and white abstract image on the left, followed by the word "carewell" in blue. Below "carewell" is the phrase "health care" in a smaller, gray font. Below the logo is the text "Shenzhen Carewell Electronics Co., Ltd."

5.8. Predicate Devices and Subject Device Comparison

Item	Subject Device	Secondary Predicate	Primary Predicate	Remark
	K180432 AI-ECG Platform	K113485 Electrocardiograph	K052883 Datrix CardioServer ECGManagement System
Product Code	DQK, DPS	DPS	DQK	Discussion 1
RegulationNumber	21 CFR 870.1425	21 CFR 870.2340	21 CFR 870.1425
RegulationDescription	Programmable diagnostic computer	Electrocardiograph	Programmable diagnostic computer
Discussion 1:	Predicate device Electrocardiograph, K113485 has ECG measuring functions and Datrix CardioServer ECG Management System, K052883 has ECGmeasuring and diagnostic functions. The subject AI-ECG Platform is a software package with automatically ECG measuring and diagnostic functions.The product codes of subject device can be covered by predicate devices K113485 and K052883.
Classification	II	II	II	Same
Indicationsfor use	The AI-ECG Platform is designed toassist physicians in measuring andinterpreting 12-lead resting ECG, andthe interpretation by the analysisprogram may then be confirmed, edited,or deleted by the physician. The programis intended for use by qualifiedhealthcare professionals in hospitals andother healthcare facilities for theassessment of common cardiacabnormalities, including arrhythmias.	Electrocardiographs, ECG-1101G(I), ECG-1103G(I), ECG-1103LW(I), ECG-1106L, ECG-1112 and ECG-1112D, areintended to acquire ECG signalsfrom adult patients through bodysurface ECG electrodes. It couldcomplete the ECG measurementsof QRS detection, Heart Rate,ventricular ectopic beat (VEB),supraventricular ectopic beat	The CardioServer ECG ManagementSystem software is intended to bemarketed to medical professionals andfor point-of-care use. The software isdesigned to provide a database usedthrough out the medical community tostore, display, edit and print highresolution ECG data received fromdevices such as electrocardiographs.The CardioServer ECG ManagementSystem software allows medical	Discussion 2
Item	Subject Device	Secondary Predicate	Primary Predicate	Remark
	K180432 AI-ECG Platform	K113485 Electrocardiograph	K052883 Datrix CardioServer ECGManagement System
	myocardial infarction, ventricularhyptrophy, and abnormal ST-T changes.The AI-ECG Platform interpretationresults are not intended to be the solemeans of diagnosis for any abnormalECG. They are offered to physicians andclinicians on an advisory basis only inconjunction with the physician'sknowledge of ECG.The AI-ECG Platform is qualified foruse in the general adult populationranging from healthy subjects to patientswith cardiac and/or non-cardiacabnormalities.The AI-ECG Platform is used withcompatible resting ECG devices whichcan export ECG recordings in CarewellECG, HL7 aECG, DICOM ECG, SCPECG, or MFER ECG data format. TheAI-ECG Platform is not to be used for:patient monitoring, on ECG signalscollected using non-standard leads, ECGsignals not collected using electrodeswith conductive paste/gel/fluid.	(SVEB) and ST SegmentDeviation. ECG withmeasurements is offered toclinician on an advisory basisonly. Digital Electrocardiographsshall be used in healthcarefacilities by doctors and/or trainedhealthcare professionals.	professionals responsible for thediagnosis and treatment of patients(adult and pediatric) with heart diseaseto: review and edit specific patient ECGdata including intervals such as QTmeasurements and algorithm generatedpreliminary interpretative statements.ECG records are all associated bypatient ID and other demographic data.Secure access to the database isprovided.
Item	Subject Device	Secondary Predicate	Primary Predicate	Remark
	K180432 AI-ECG Platform	K113485 Electrocardiograph	K052883 Datrix CardioServer ECGManagement System
Discussion 2:	The subject device has smaller intended patient population scope, similar measuring functions, similar diagnostic functions scope and smaller supportedECG types scope. Others in the IFU are all the same. Therefore, the noted difference in indications for use does not raise any new issues of safety oreffectiveness. It could be considered as substantially equivalent to that of the predicate devices.
Algorithm	Carewell ECG Measurement Algorithm+ Carewell ECG AI algorithm	Carewell ECG MeasurementAlgorithm	Glasgow ECG analysis for 12 leadECG	Discussion 3
Discussion 3:	The subject device AI-ECG Platform and the predicate device Electrocardiograph, K113485 are both produced by Shenzhen Carewell Electronics Co.,Ltd. The measurement algorithm in the predicate device is also used in the subject device. AI algorithm is also used in junction with the previous algorithm.New algorithm is added into use to realize automatically interpreting ECGs and produce interpretation statement for the physician to reference.Though the subject device and predicate device K052883 use different algorithm, they are both intended to realize substantially equivalent intended use.It could be considered as substantially equivalent to that of the predicate device.
Level ofConcern ofthe software	Major	Moderate	Not specified in 510 (K) summary	Discussion 4
Discussion 4:	The subject device K180432 AI-ECG Platform can provide diagnostic information about myocardial infarction (MI). The diagnostic information thesoftware provided may result in a delayed response of appropriate medical care that would lead to serious injury or death. The Level of Concern of thesoftware is Major. Predicate device K113485 doesn't provide diagnostic information and the software LoC is moderate. Though the level of concern ofpredicate device K052883 is not specified in 510 (K) summary, the predicate device K052883 can provide substantial equivalent diagnostic statement.The LoC of subject device K180432 is Major which is the highest level. So the software development is controlled as the strictest level. It could beconsidered as substantially equivalent to that of the predicate device.
Fundamentalscientific	The AI-ECG Platform performs thefollowing functions:	--	CardioServer ECG ManagementSystem can realize the following	Discussion 5
Item	Subject Device	Secondary Predicate	Primary Predicate	Remark
	K180432 AI-ECG Platform	K113485 Electrocardiograph	K052883 Datrix CardioServer ECGManagement System
technology	* Receive EGGs via local wired and/orwireless network, USBs, and otherstandard transmission methods;* Store, archive, and display EGGs;* Export EGGs in industry standardformats to electronic health records;* Print EGGs;* Utilize Windows standards;* Secure access to patient healthinformation;* Log patient health information;* Provide clinical access to EGG dataacross the users local network;* Provide automatically measurementsand interpretations of ECGs* Allow user editing of ECGinterpretation;* Provide tools for user to manuallymeasure EGGs;* Generate ECG reportsOperating System requirement:Windows XP/7/8/10 32bit/64bitOperating System, Windows Server2008/2012, Internet Information	functions:	functions:* Receive EGGs via wireless LAN,LAN, USB2, and other standardtransmission modes;* Store, archive, and display EGGs;* Export EGGs in industry standardformats to electronic health records;* Print EGGs;* Utilize Windows standards;* Provide secure access to patienthealth information;* Log all interaction with patient healthinformation;* Provide clinical access to EGG dataacross the users network;* Utilize the University of GlasgowEGG Algorithm for data interpretation;* Allow user editing of ECGinterpretation;* Provide EGG measurements;* Gontain calipers for user edit of EGGmeasurements;* Generate management reportsHardware requirements: are Windows
Item	Subject Device	Secondary Predicate	Primary Predicate	Remark
	K180432 AI-ECG Platform	K113485 Electrocardiograph	K052883 Datrix CardioServer ECGManagement System
	Server 7/8, Microsoft Sql Server 2008The four subsystems have differenthardware requirements includingprocessor, memory (RAM), Hard drivesize, Nvidia GPU (optional) , screenresolution, printer etc.		2000 or 2003 Server operating system;Pentium IV, 2GHz (minimum); 512MB RAM (minimum); 10/1 00Ethernet (minimum); RAID 5 storage;1024x768 monitor; and standard back-up technology.
Discussion 5:

Table 3-1 Feature Comparison with Predicate Devices

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Image /page/7/Picture/0 description: The image shows the logo for Shenzhen Carewell Electronics Co., Ltd. The logo includes a graphic of pink horizontal lines on the left. To the right of the graphic is the company name "carewell" in a dark blue font, with the words "health care" in a smaller, light gray font underneath. The full company name, "Shenzhen Carewell Electronics Co., Ltd.", is printed in black below the logo.

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Image /page/8/Picture/0 description: The image shows the logo for Carewell health care. The logo consists of a pink circular design on the left and the word "carewell" in blue on the right. Below "carewell" is the phrase "health care" in a smaller, gray font. Underneath the logo is the text "Shenzhen Carewell Electronics Co., Ltd."

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Image /page/9/Picture/0 description: The image shows the logo for Carewell health care. The logo consists of a pink circular design on the left and the word "carewell" in dark blue on the right. Below "carewell" is the phrase "health care" in light gray. Below the logo is the text "Shenzhen Carewell Electronics Co., Ltd."

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Image /page/10/Picture/0 description: The image shows the logo for Carewell. The logo consists of a pink circular design to the left of the word "carewell" in a dark blue font. Below "carewell" are the words "health care" in a light gray font. Below the logo is the text "Shenzhen Carewell Electronics Co., Ltd."

The subject device AI-ECG Platform and the KI5283 can realize similar functions including receiving, storing, interpreting, exporting and printing ECG reports. They both have a user's interface for viewing, and interpreting ECG data, algorithms and APIs (Application Programming Interface) to access to the algorithms. They both have similar requirements for the operating system and hardware.

The subject device is installed on the user's hardware and work or access through a local network. All the data processing and transmitting are in a secured local network environment. Both the devices use secured access technology.

The subject device AI-ECG Platform therefore does not present any major technological innovations compared to predicate device.

Item	Subject DeviceK180432 AI-ECG Platform	Secondary PredicateK113485 Electrocardiograph	Primary PredicateK052883 Datrix CardioServer ECGManagement System	Remark
Basic safetyand essentialperformance	Comply with IEC 60601-2-25	Comply with IEC 60601-2-25	--	Same
Measurementperformance	Comply with AAMI/ANSI EC57.	Comply with AAMI/ANSI EC57.	--	Same

Table 3-2 Performance Comparison
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Image /page/11/Picture/0 description: The image shows the Carewell Health Care logo. The logo consists of a circular graphic on the left and the text "carewell health care" on the right. The word "carewell" is in a larger, bold, dark blue font, while "health care" is in a smaller, lighter gray font and is positioned below "carewell."

5.9. Non-Clinical Test Conclusion

Bench test were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards.

AAMI ANSI EC57:2012 Testing And Reporting Performance Results Of Cardiac Rhythm And ST-Segment Measurement Algorithms

IEC 60601-2-25:2011, Medical Electrical Equipment -- Part 2-25: Particular requirements for the safety of electrocardiographs;

IEC 62304:2015, Medical device software - Software life-cycle

ISO 14971: 2007, Medical devices-Application of risk management to medical device

5.10. Substantially Equivalent Conclusion

The subject device, AI-ECG Platform, is determined to be Substantially Equivalent (SE) to the predicate device, Electrocardiograph, K113485 and Datrix CardioServer ECG Management System, K052883.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).