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.

Device Description

PC ECG including model SE-1010 has the similar functions of an ordinary electrocardiograph. ECG data can be sampled, displayed and stored in PC machine, and they can be printed with several kinds of printing types, including PDF format, word format and JPG format. ECG wave can be frozen and reviewed. Auto measurement and diagnosing is available, and Diagnose Template can be edited. 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 PC ECG (model SE-1010). However, it does not contain a detailed study proving the device meets specific acceptance criteria for performance, especially regarding its "auto measurement and diagnosing" capabilities.

The document primarily focuses on:

Substantial equivalence to a predicate device (Cardiosoft/case cardiac testing system, K031561).
General device description and intended use.
Mention of general quality assurance measures (software testing, risk analysis, safety testing, environment test, verification and validation testing) to demonstrate substantial equivalence.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to answer the questions based only on the provided information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific performance criteria (e.g., sensitivity, specificity for diagnostic functions)	Not provided in the document. The document states "Auto measurement and diagnosing is available" but offers no performance metrics.
Ability to acquire ECG signals from adult and pediatric patients.	Stated in "Intended Use" and "Device Description". No specific performance metrics (e.g., signal quality, artifact rejection) are given.
Display and storage of ECG data in PC machine.	Stated in "Device Description". No specific performance metrics are given.
Printing with several kinds of printing types (PDF, Word, JPG).	Stated in "Device Description". No specific performance metrics are given.
ECG wave frozen and reviewed.	Stated in "Device Description". No specific performance metrics are given.
Auto measurement and diagnosing.	Stated in "Device Description". No performance data is provided to demonstrate accuracy or reliability of these functions. The document explicitly states "the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only."
Measurement point adjustment and re-analyzing, manual measurement.	Stated in "Device Description". No specific performance metrics are given.
Data management and processing.	Stated in "Device Description". No specific performance metrics are given.
Multi-language support.	Stated in "Device Description". No specific performance metrics are given.
Automatic baseline adjustment.	Stated in "Device Description". No specific performance metrics are given.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for any specific performance study related to the "auto measurement and diagnosing" feature. The document only mentions "Verification and validation testing was done on PC ECG." without detailing the scope or data used.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified.

4. Adjudication method for the test set

Not specified.

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 MRMC comparative effectiveness study is mentioned or detailed in the document. The device's diagnostic interpretation is stated to be "advisory basis only," which suggests a standalone or assistive role rather than a replacement for human interpretation based on a proven MRMC study.

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

A standalone performance study for the interpretive algorithm is not detailed in the document. While "Auto measurement and diagnosing is available," no performance metrics (e.g., sensitivity, specificity, accuracy) are provided for this function.

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

Not specified for any analytical or diagnostic performance studies.

8. The sample size for the training set

Not applicable/Not specified. There is no mention of a machine learning or AI model being "trained" in this document. The "auto measurement and diagnosing" feature likely refers to rule-based algorithms or established clinical criteria, rather than a modern AI/ML model requiring a distinct "training set."

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

Not applicable/Not specified, as no training set is mentioned.

Summary of what is present:
The 510(k) summary primarily asserts substantial equivalence to a predicate device based on similar functions and general quality assurance processes. It lists capabilities of the device but does not provide any specific quantitative performance data or details of studies validating the accuracy of its diagnostic or measurement features. The diagnostic statements are explicitly advisory.

Summary

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K092010
20 page 1 of 2

510(K)Summary of Safety and Effectiveness

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 26882220Fax:+86 755 26882223	OCT 22 2009
Contact person:	Jiang yucaiEdan Instruments, Inc.
Date:	2009-6-29
Proprietary Name:	PC ECG
Classification Name:	21 CFR 870.2340 Electrocardiograph
Product code:	DPS
Predicate Devices:	Cardiosoft/case cardiac testing systemManufacturer: GE medical systems information technologiesK031561
Device Description:	PC ECG including model SE-1010 has the similar functionsof an ordinary electrocardiograph. ECG data can be sampled,displayed and stored in PC machine, and they can be printedwith several kinds of printing types, including PDF format,word format and JPG format. ECG wave can be frozen andreviewed. Auto measurement and diagnosing is available,and Diagnose Template can be edited.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

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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

Intended Use:

Test Summary:

Conclusion:

The following quality assurance measures were applied to the development of the Fetal & Maternal Monitor

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

OCT 22 2009

Edan Instruments, Inc. c/o Mr. William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, NY 10701

Re: K092010

PC ECG Model SE-1010 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: Undated Received: September 17, 2009

Dear Mr. Stern:

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 such 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 - Mr. William Stern

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.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,

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

510(k) Number (if known): K 092010

Device Name: PC ECG

Prescription Use

Over the Counter Use (21 CFR Part 801 Subpart C)

(21 CFR Part 801 Subpart D)

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

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K092 010

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).