Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional.

Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.

Device Description

Disposable ECG Cable and Leadwires with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors.

These devices consist of connectors on each cable end and a shielded bulk cables are used to transfer the signals from the electrodes to the patient monitor.

These devices use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC and TPU cable jacket with medical grade PVC and ABS over molded connectors with integral relief.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the "Med-link Disposable ECG Cable and Leadwires," but it does not contain information about a study proving the device meets acceptance criteria in the way you've outlined.

The document is a 510(k) premarket notification summary, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical or detailed standalone studies.

Here's a breakdown of why this document doesn't fit your request and what information it does provide:

Type of Device: The device is a Disposable ECG Cable and Leadwires, which is an accessory to ECG monitoring devices, not a diagnostic algorithm or AI system. Therefore, the concepts of "sensitivity," "specificity," "AI improvement," "training sets," "test sets," "ground truth," or "expert adjudication" as typically applied to AI/ML medical devices are not relevant here.
Purpose of 510(k): The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a predicate device already on the market, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

Given this context, I cannot fill out your requested table and information points as they pertain to a different type of device evaluation (e.g., for an AI/ML diagnostic software).

However, I can extract the information that is relevant to the document provided:

Summary of Device Evaluation (as per the 510(k) Summary):

Acceptance Criteria and Device Performance (based on regulatory standards rather than clinical endpoints):

Acceptance Criteria (Standard / Test)	Reported Device Performance
Electrical Safety: IEC 60601-1 (General requirements for basic safety and essential performance)	Complied with IEC 60601-1. The proposed device was tested according to IEC 60601-1. The safety performances are demonstrated by the Third party, CTI through testing following IEC 60601-1.
ECG Cable and Leadwires Performance: ANSI/AAMI EC53:2013 (ECG Trunk Cables And Patient Leadwires)	Meets the requirements of the standard ANSI/AAMI EC53. The proposed device was tested according to EC53. The safety performances are demonstrated by the Third party, CTI through testing following ANSI AAMI EC53. The results of bench testing & type testing provide reasonable assurance that the proposed device has been designed and validated to assure conformance to the requirements for its indication for use.
Biocompatibility: ISO 10993-1, ISO 10993-5, ISO 10993-10 (Biological evaluation of medical devices) (Specifically for material difference: ISO 10993-10 for irritation and skin sensitization)	Complied with ISO 10993-1, ISO 10993-5, ISO 10993-10. For the material difference, the proposed device was specifically tested according to ISO 10993-10. The biocompatibility performance equivalence evidence can be demonstrated.
Shelf Life / Package Integrity: (Functional performance testing following real-time aging test)	Package integrity and functional performance testing were completed on the subject device following real time aging test to support the proposed shelf life.

Here's why the other points you requested are not available in this document:

Sample size used for the test set and data provenance: Not applicable. This device is an accessory (cable/leadwire) and its performance is evaluated against engineering/safety standards (IEC, AAMI, ISO), not clinical data sets with "test sets" or "data provenance" in the context of an algorithm. The testing involves bench and type testing of the physical device according to standards.
Number of experts used to establish the ground truth... and their qualifications: Not applicable. There is no "ground truth" to establish through experts for an ECG cable's performance in the way a diagnostic algorithm requires. Compliance to standards is verified through laboratory testing.
Adjudication method: Not applicable. No human adjudication is mentioned or relevant for electrical and biocompatibility testing of a cable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML diagnostic device, so MRMC studies are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: Not applicable. The "ground truth" here is compliance with established engineering and safety standards, verified through bench testing.
The sample size for the training set: Not applicable. There is no "training set" for an ECG cable.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document details the "substantial equivalence" of an ECG cable to a predicate device by demonstrating compliance with relevant international and national standards for electrical safety, performance, and biocompatibility through non-clinical (bench and type) testing, not through a clinical study with acceptance criteria for diagnostic accuracy metrics.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 28, 2022

Shenzhen Med-link Electronics Tech Co., Ltd. Yi Liu Regulatory Affairs Specialist 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street Shenzhen, Guangdong 518109 China

Re: K220447

Trade/Device Name: Med-link Disposable ECG Cable and Leadwires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: April 29, 2022 Received: May 9, 2022

Dear Yi Liu:

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. Although this letter refers to your product as a device, please be aware 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.

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

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); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220447

Device Name Disposable ECG Cable and Leadwires

Indications for Use (Describe)

Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional.

Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for MedLinket. The logo is composed of the word "MedLinket" in a sans-serif font. The first letter, "M", is colored in orange, while the rest of the letters are in light blue.

Shenzhen Med-link Electronics Tech Co., Ltd.

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter information:
Name and Address:	Shenzhen Med-link Electronics Tech Co., Ltd.4th and 5th Floor, Building Two,Hualian Industrial Zone, Xinshi Community,Dalang Street, Longhua District, Shenzhen,Guangdong 518109,People's Republic of China
Primary Contact:	Yi Liu(Regulatory Affairs Specialist)E-mail: user22@med-linket.comTel: 0086-755-61568825Fax: 0086-755-61120055
Data of Preparation:	29, Apr. 2022
2. Device Information:
Trade Name:	Disposable ECG Cable and Leadwires
Common Name:	Cable and Leadwires
Classification number:	21 CFR 870.2900
Classification name:	Cable, Transducer And Electrode, Patient, (Including Connector)
Product Code:	DSA
Regulatory Class:	II
Review Panel:	Cardiovascular

3. Identification of the Predicate Device:

Device Name	Common Name	Manufacturer	510(k)number
Cable/ lead-wire (ECG,EKG, SPO2 and invasiveblood pressure	Cable and Leadwires	Shenzhen Med-Link ElectronicsTech Co., Ltd.	K120010

{4}------------------------------------------------

Medlinket

Intended Use and Indications for Use of the Subject Device 4.

Disposable ECG Cable and Leadwires are intended to be used with ECG monitoring devices to measure a patient's ECG for general monitoring and/or diagnostic evaluation by heath care professional.

Disposable ECG Cable and Leadwires meets the requirements of the standard ANSI/AAMI EC53, ECG TRUNK CABLES and PATIENT LEADWIRES. This leadwire set is intended for single-patient use.

Device Description ട്.

These devices consist of connectors on each cable end and a shielded bulk cables are used to transfer the signals from the electrodes to the patient monitor.

Item	Proposed Device	Predicate Device	Remark
Comparison	DisposableECG Cable and Leadwires	Shenzhen Med-linkCable/lead-wire	/
510k number	K220447	K120010	/
510(K) Submitter	Shenzhen Med-linkElectronics Tech Co., Ltd.	Shenzhen Med-linkElectronics Tech Co., Ltd.	/
Intended use&Indicationsfor Use	Disposable ECG Cable andLeadwires are intended to be usedwith ECG monitoring devices tomeasure a patient ' s ECG forgeneral monitoring and/ordiagnostic evaluation by heathcare professional.Disposable ECG Cable and	Shenzhen Med-linkCable/lead-wire is intended to beused with ECG, EKG, SpO2 andinvasive Blood Pressuremonitoring devices. TheCable/lead-wire are used toconnect electrodes, catheters,and/or sensors placed at	SE
	Leadwires meets the requirementsof the standard ANSI/AAMIEC53, ECG TRUNK CABLESand PATIENT LEADWIRES.This leadwire set is intended forsingle-patient use.	appropriate sites on the patient to amonitoring device for generalmonitoring and/or diagnost icevaluation by health careprofessional.
Device description	Disposable ECG Cable andLeadwires with specific variouslengths are the replacements forsimilar cables manufactured byOriginal EquipmentManufacturers (OEM) and otherthird party after marketmanufacturers for their respectivemonitors.These devices consist ofconnectors on each cable end anda shielded bulk cable. The cablesare used to transfer the signalsfrom the electrodes to the patientmonitor.	Med-link Cable / Lead-wire withspecific various lengths are thereplacements for similar cablesmanufactured by OriginalEquipment Manufacturers (OEM)and other third party after marketmanufacturers for their respectivemonitors.These cables consist of connectorson each cable end and a shieldedbulk cable. The cables are used totransfer the signals from theelectrodes to the patient monitor.	SE
AnatomicalSites	Attached to electrodes placed atstandard specified locations onchest wall	Attached to electrodes placed atstandard specified locations onchest wall	SE
Design/Appearance	ECG and EKG Cableswith various connectors (monitor	ECG and EKG Cableswith various connectors (monitor	SE
	trunk / lead wire,electrode grabber& snapper)	trunk / lead wire,electrode grabber& snapper)
Sterility	Non sterile	Non sterile	SE
Usage	Disposable	Reusable	Different1)
Patient endtermination	Clip	Clip, Snap	Different2)
Material	PVC	Shielded & Unshielded Copperwith PVC or TPU Jacket	Different3)
Cable Length	Various specifiedstandard lengths	Various specifiedstandard lengths	SE
Electrical Safety	Complied with IEC 60601-1 andEC53	Complied with IEC 60601-1 andEC53	SE
Biocompatibility	Complied with ISO 10993-1, ISO10993-5, ISO 10993-10	Complied with ISO 10993-1, ISO10993-5, ISO 10993-10	SE

8. Comparison to the Predicate Device

{5}------------------------------------------------

Tedli ket

{6}------------------------------------------------

Shenzhen Med-link Electronics Tech Co., Ltd.

Justifications for differences between proposed device and the predicate device are shown as below:

Different (1): The proposed device is disposable and the predicate device is reusable. The proposed device was tested according to IEC 60601-1 and EC53. Therefore, this difference does not raise new questions of safety and effectiveness for subject device as compared to the predicate device.

Different (2): The patient end termination is different. This end is intended to connect the electrodes. The proposed device was tested according to IEC 60601-1 and EC53. Therefore, this difference does not raise new questions of safety and effectiveness for subject device as compared to the predicate device.

Different (3): The material is different. The proposed device was tested according to ISO 10993-10. Therefore, this difference does not raise new questions of safety and effectiveness for subject device as compared to the predicate device.

9. Non-clinical Test

Compare to predicate product specified in K120010, our device and the predicate device are same in Essential Components, raw materials, physical features, and same manufacturing processes. The biocompatibility performance equivalence evidence of proposed electrode can be demonstrated.

{7}------------------------------------------------

MedLinket

The safety performances of subject device are demonstrated by the Third party, CTI through testing following IEC 60601-1 General requirements for basic safety and essential performance and ANSI AAMI EC53:2013 ECG Trunk Cables And Patient Leadwires.

The results of bench testing & type testing provide reasonable assurance that the proposed device has been designed and validated to assure conformance to the requirements for its indication for use.

Package integrity and functional performance testing were completed on the subject device following real time aging test to support the proposed shelf life.

11. Conclusion

Based on the comparison and analysis in this submission, it can be concluded that: Disposable ECG Cable and Leadwires is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).