SE-1010 PC ECG is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-1010 PC ECG is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

Device Description

PC ECG is a kind of resting and exercising electrocardiograph based on PC. PC ECG including data sampling modules and software which can be installed on desktop or laptop PC. PC ECG can acquire 12 channel waveforms simultaneously, which can also print out 3/6/12 channel electrocardiograph wave simultaneously by a 210mm (A4) wide printer. Advanced digital filter technique has been used in PC ECG including baseline anti-drift filter AC noise (50/60Hz) filter EMG Filter and Low pass Filter, which can help the user to record the ECG more clearly. Measurement Moreover, the ECG and interpretation program(SEMIP) is included in this machine, this program can provide more detail information to diagnose heart disease. PC ECG has the features as follows: 3/6/12-channel ECG wave display and printing simultaneously ECG wave frozen and review Measurement point adjustment and re-analyzing, manual measurement with high precision electronic ruler data management and processing function Report printing with PDF format, word format or JPG format Multi-language supporting Supporting auto measurement and diagnosing Automatic baseline adjustment for optimal printing

AI/ML Overview

The provided text is a 510(k) summary for the Edan Instruments, Inc. PC ECG device. While it mentions “Software testing”, “Risk analysis”, “Safety testing”, and “Environment test” as quality assurance measures, it does not provide detailed acceptance criteria or a study that specifically proves the device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy for disease detection).

The document is primarily a regulatory submission summarizing the device, its intended use, and its substantial equivalence to predicate devices (Cardiosoft/case cardiac testing system, K031561; and PC ECG, MODEL SE-1010, K092010).

Therefore, based only on the provided text, I cannot complete most of the requested information regarding acceptance criteria and performance studies.

Here's what can be extracted and what cannot:

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

Cannot be provided. The document states "Verification and validation testing was done on PC ECG" but does not define specific acceptance criteria (e.g., minimum sensitivity/specificity for particular conditions) or report detailed performance metrics against such criteria. The mention of "auto measurement and diagnosing" implies some diagnostic capability, but no performance figures are given.

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

Cannot be provided. The document does not mention any specific test set, its size, or provenance for evaluating diagnostic performance.

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)

Cannot be provided. No information about a test set or ground truth establishment is present.

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

Cannot be provided. No information about a test set or adjudication is present.

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

Cannot be provided. The document does not describe any MRMC study or an "AI assistance" component in the context of improving human reader performance. The device includes an "interpretation program (SEMIP)" for diagnosis, but its impact on human readers is not studied.

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

Cannot be provided definitively for diagnostic performance. The document states "Supporting auto measurement and diagnosing" and "can provide more detail information to diagnose heart disease" regarding the SEMIP. It also states "However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only." This suggests a standalone interpretive function, but no performance metrics (e.g., accuracy against a gold standard) for this standalone function are provided in the text.

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

Cannot be provided. No information about ground truth for performance evaluation is present.

8. The sample size for the training set

Cannot be provided. There is no mention of a training set or its size.

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

Cannot be provided. There is no mention of a training set or its ground truth establishment.

Summary of Available Information from the Provided Text:

The document describes the PC ECG device as a PC-based electrocardiograph that acquires and processes 12-channel ECG waveforms. It includes an "ECG and interpretation program (SEMIP)" which can "provide more detail information to diagnose heart disease" and offers "auto measurement and diagnosing". However, the interpretive statements are "offered to clinician on an advisory basis only."

The regulatory submission focuses on demonstrating substantial equivalence to predicate devices (Cardiosoft/case cardiac testing system K031561 and PC ECG, MODEL SE-1010 K092010), rather than presenting a detailed clinical performance study for its interpretive function. The "Test Summary" only lists general quality assurance measures like "Software testing", "Risk analysis", "Safety testing", and "Environment test," without specifying performance-based acceptance criteria or results.

Summary

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PC ECG special 510k modification SUBMISSION

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. . . .

DEC - 3 2010.'

510(K)Summary of Safety and Effectiveness

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This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

Submitter:	Edan Instruments, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86755 26899197Fax:+86 755 26882223
Contact person:	Yue Qiuhong (Tracy)Edan Instruments, Inc.
Date:	2010-9-20
Proprietary Name:	PC ECG
Classification Name:	21 CFR 870.2340 Electrocardiograph
Product code:	DPS
Predicate Devices:	Cardiosoft/case cardiac testing systemK031561Manufacturer: GE medical systems information technologiesPC ECG, MODEL SE-1010K092010Manufacturer: Edan Instruments, Inc
Device Description:	PC ECG is a kind of resting and exercisingelectrocardiograph based on PC. PC ECG including datasampling modules and software which can be installed ondesktop or laptop PC. PC ECG can acquire 12 channelwaveforms simultaneously, which can also print out 3/6/12channel electrocardiograph wave simultaneously by a210mm (A4) wide printer.Advanced digital filter technique has been used in PC ECGincluding baseline anti-drift filter AC noise (50/60Hz) filterEMG Filter and Low pass Filter, which can help the user torecord the ECG more clearly.

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Measurement Moreover, the ECG and interpretation program(SEMIP) is included in this machine, this program can provide more detail information to diagnose heart disease.

PC ECG has the features as follows:

। 3/6/12-channel ECG wave display and printing simultaneously

ECG wave frozen and review ।

Measurement point adjustment and re-analyzing, manual ー measurement with high precision electronic ruler

data management and processing function ।

Report printing with PDF format, word format or JPG ﺳﮯ format

Multi-language supporting ।

Supporting auto measurement and diagnosing -

। Automatic baseline adjustment for optimal printing

Intended Use:

Test Summary:

The following quality assurance measures were applied to the development of the PC ECG Electrocardiograph

Software testing ●
Risk analysis .
. Safety testing
Environment test �

Conclusion:

Verification and validation testing was done on PC ECG. This premarket notification submission demonstrates that PC ECG is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the staff and a serpent intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

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

Edan Instruments, Inc. c/o Ms. Yue Qiuhong Registrar 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019# Shekou, Nanshan Shenzhen, 518067 P.R. China

DEC - 3 2010

Re: K102854

Trade/Device Name: PC ECG Model SE-1010 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: October 28, 2010 Received: November 8, 2010

Dear Ms. Qiuhong:

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 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.

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Page 2 – Ms. Yue Qiuhong

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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

[signature]

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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Indication for Use

KID2854 510(k) Number (if known):

Device Name: PC ECG

SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-1010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.

× Prescription Use Or Over the Counter Use (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

W.M.S

1 of 1

DEC - 3 2010

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).