The Portable ECG Monitor PM10 is intended to record and store Lead I ECG signals, and display heart rate for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. Users with implanted pacemaker are not recommended to use this device. The Portable ECG Monitor PM10 has simple user interface without ECG trace viewing function.

Device Description

The Portable ECG Monitor is intended to record and store Lead I ECG signals, and display heart rate for home health care use. It is composed of host and USB cable, powered by Built-in large capability rechargeable lithium battery.

The device can be connected with PC via USB, with mobile phone via Bluetooth protocol. The function of software PC and mobile phone includes sample mode and time setting, upload case, case review, measurement etc.

AI/ML Overview

The provided text is a 510(k) Summary for the Contec Medical Systems Co., Ltd Portable ECG Monitor, model PM10. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a novel device. As such, much of the requested information regarding detailed study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format as it would for a performance study. Instead, it compares the proposed device's specifications to those of a predicate device to establish substantial equivalence. The "acceptance" in this context is that the device's measured performance aligns with or is sufficiently similar to the predicate's, and meets relevant voluntary consensus standards.

Here's a table based on the "Substantially Equivalent (SE) Comparison" in the document (Table 1):

Characteristic / Acceptance Criteria (Implied)	Predicate Device (K112622) Performance	Proposed Device (PM10) Performance
Product Code	DPS (Implied from "Same")	DPS
Regulation Number	870.2340 (Implied from "Same")	870.2340
Intended Use	Record/store Lead I ECG, display HR	Record/store Lead I ECG, display HR
Lead	Lead I (Implied from "Same")	Lead I
Recording mode	Automatic (Implied from "Same")	Automatic
Measurement parameters	Heart rate	Heart rate
Display	LCD (Implied from "Same")	LCD
HR measurement range	(Not explicitly stated for predicate)	30bpm~300bpm
HR measurement accuracy	(Not explicitly stated for predicate)	±1bpm or 1%
Power supply	Battery (Implied from "Same")	Battery
Electrical safety conformance	(Implied to comply with IEC 60601-1)	Complies with IEC 60601-1
EMC conformance	(Implied to comply with IEC 60601-1-2)	Complies with IEC 60601-1-2
Patient Contact Material	Metal electrode (Implied from "Same")	Metal electrode

Explanation of "Acceptance Criteria" for this submission: For a 510(k), the "acceptance criteria" largely involve demonstrating that the device meets recognized standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 60601-2-47, IEC 60601-1-11, ISO 10993-5, ISO 10993-10) and has performance characteristics that are "substantially equivalent" to a legally marketed predicate device. The document explicitly states "The test results demonstrated that the proposed device complies with the following standards" for non-clinical tests.

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no sample size for a clinical test set, nor any information on data provenance (country, retrospective/prospective). The assessment relies on non-clinical engineering and bench testing, and comparison to a predicate device.

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, as no clinical study or test set with human data requiring expert ground truth was conducted or submitted (see point 2).

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

Not applicable, as no clinical study or test set was conducted that would require adjudication.

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

Not applicable. This device is a "Portable ECG Monitor" for recording and displaying heart rate, not an AI-driven diagnostic tool that assists human readers. No MRMC study was conducted.

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

The device's core functions (recording ECG signals and displaying heart rate) are standalone in nature, as it processes the ECG signal and derives heart rate without human intervention in that specific computation. However, this is not an "algorithm-only" performance study in the sense of a complex AI diagnostic algorithm. The non-clinical tests verifying its compliance with standards and its stated heart rate accuracy (±1bpm or 1%) serve as the standalone performance verification.

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

For the non-clinical tests:

Electrical safety and EMC: Ground truth is defined by the technical requirements and test procedures outlined in the specified IEC standards (IEC 60601-1, IEC 60601-1-2). Compliance with these standards is the "ground truth."
Biocompatibility: Ground truth is established by the test procedures and acceptance criteria within ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization).
Heart rate accuracy: The accuracy of ±1bpm or 1% would be verified against a known, precise input signal (e.g., using an ECG simulator or a reference standard). The known input signal acts as the "ground truth."

8. The sample size for the training set

Not applicable. This document describes a traditional medical device, not a machine learning or AI device that requires a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

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

June 22, 2016

Contec Medical Systems Co., Ltd % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K152863

Trade/Device Name: Portable ECG Monitor Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: May 20, 2016 Received: May 23, 2016

Dear Diana Hong:

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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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

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 (OS) 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,

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152863

Device Name Portable ECG Monitor

Indications for Use (Describe)

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

] Prescription Use (Part 21 CFR 801 Subpart D)

X 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 Druq 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}------------------------------------------------

Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number:

1. Date of Preparation: 05/21/2016
1. Sponsor Identification

Contec Medical Systems Co., Ltd

No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China.

Establishment Registration Number: 3006979678

Contact Person: Xueyong Li Position: Quality Manager Tel: 86 355 8015489 Fax: 86 355 8015490 Email: lxy1011@163.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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

4. Identification of Proposed Device

Trade Name: Portable ECG Monitor Common Name: Electrocardiograph Model: PM10

Regulatory Information Classification Name: Electrocardiograph Classification: Class II Product Code: DPS Regulation Number: 21 CFR 870.2340 Review Panel: Cardiovascular

Intended Use Statement:

Device Description

ર. Identification of Predicate Device
510(k) Number: K112622 Product Name: Handheld ECG Monitor Model Name: MD100A1-F

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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

Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.

ISO 60601-2-47:2012, Medical Electrical Equipment -- Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems.

IEC 60601-1-11: 2010, MEDICAL ELECTRICAL EQUIPMENT – Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

ISO 10993-5:2009(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.

ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Substantially Equivalent (SE) Comparison

Item	Proposed Device(s)	Predicate Device(s)
Product Code	DPS	Same
Regulation Number	870.2340	Same
Intended Use	The Portable ECG Monitor PM10 is intendedto record and store Lead I ECG signals, anddisplay heart rate for home health care use.The intended users are adults above 20 yearsold. This device is not intended to substitutefor a hospital diagnostic ECG device. Userswith implanted pacemaker are notrecommended to use this device. The PortableECG Monitor PM10 has simple user interfacewithout ECG trace viewing function.	Similar
Lead	Lead I	Same
Recording mode	automatic	Same
Measurementparameters	Heart rate	Similar
Display	LCD	Same
HR measurementrange	30bpm~300bpm	Similar
HR measurementaccuracy	±1bpm or 1%	Similar

Table 1 Comparison of Technology Characteristics

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

Power supply	Battery	Same
Electrical safety	The proposed device was tested to demonstrated to comply with IEC 60601-1	Same
EMC	The proposed device was tested to demonstrated to comply with IEC 60601-1-2	Same
Patient Contact Material	Metal electrode	Same

9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).