The Cardiofax V electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a patient record (monitor and recorder) and prepare a record and/or provide wireless transmission of data to a remote printer and/or computer.

For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician.

The devices also provide an interpretive ECG program intended for use with patients age 3 years and older. The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.

Device Description

Nihon Kohden's ECG-1500A series is intended for medical purposes to process the electrical signals produced by the heart through electrocardiograph electrodes and to produce a visual display, to produce a record and/or to transmit data to a remote computer. The product is a portable ECG acquisition terminal, which measures up to 15 lead ECG waveforms. The measured ECG waveforms are analyzed and a patient record is prepared for transfer to an ECG data filing system thru a wireless LAN or may be printed by integral printer with optional model available with recorder. Measurements and waveforms and diagnostic information are offered to physicians on an advisory basis.

The ECG-1500A series prepares a full page file with 3 to 15 channel selectable formats, waveform display and waveform analyses with measurements. The device includes keyboard data entry, battery with internal battery recharging circuit and AC power operation , all of which are features of the predicate devices. The new device offers an optional PC memory card, comparable to the predicate Nihon Kohden's ECGs. The new device does offer an external optional printer and uses a different type of battery. These changes have been made to address user preferences and do not affect the indication for use or safety and efficacy of the new device.

AI/ML Overview

The provided text is a 510(k) summary for the Nihon Kohden ECG-1500A series electrocardiograph. It describes the device, its intended use, and states that it has undergone testing and is believed to be substantially equivalent to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details about performance metrics (sensitivity, specificity, accuracy, etc.) beyond a general statement that "The results confirmed that the device performed within specifications."

Therefore, I cannot provide the requested table or answer most of the questions, as the information is not present in the provided text.

Here's what I can infer or answer based on the given document:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document only states, "The results confirmed that the device performed within specifications," but doesn't list the specifications or performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document. The document mentions an "interpretive ECG program" for diagnosis assistance, which states, "All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography." This refers to clinical use, not the establishment of ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
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 provided in the document. The device offers an "interpretive ECG program" but no study details are given about its impact on human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated as a standalone performance study in the context of diagnostic accuracy. The document mentions "Software validation tested the operation of the software of the device," but this generally refers to functional and safety testing, not standalone diagnostic performance against a ground truth. The interpretive program is explicitly stated to assist the physician and not be the sole basis for diagnosis, implying it's not intended for standalone use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in the document.
8. The sample size for the training set: Not provided in the document.
9. How the ground truth for the training set was established: Not provided in the document.

Summary

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NIHON KOHDEN AMERICA

510K SUBMISSION FOR ECG-1500A Series

SECTION 2 - 510(K) SUMMARY August 2005

052511
page 1 of 1

Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs Serrah Namini 90 Icon St. Foothill Ranch, Ca 92610 (949) 580-1555 Ext 4401 Fax: (949) 580-1550

MAY 2 4 2006

Trade Name: ECG-1500A series / Cardiofax V Common Name: Electrocardiograph or ECG Classification Name: The device has been classified as Class II by the Division of Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" per 74LOS.

The device complies with the IEC 60601-1 standard and sub-clause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables.

The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software of the device. The results confirmed that the device performed within specifications.

Therefore based on the above. Nihon Kohden believes that the ECG-1500A series is substantially equivalent to our predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2006

Ms. Serrah Namini Regulatory Affairs, Associate Director Nihon Kohden America, Inc. 90 Icon St. Foothill Ranch, CA 92610

Re: K052511

Trade Name: Cardiofax CE, Model ECG-1500 A Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: April 19, 2006 Received: April 19, 2006

Dear Ms. Namini:

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.

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

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Page 2 - Ms. Serrah Namini

comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the 110 110 - 110 millions (21); good manufacturing practice requirements as set CITY art 607), labeling (21 OF X Part 820), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro needs (2001) (2006) 100 as described in your Section 510(k) I mis letter will anow you to begal finding of substantial equivalence of your device to a legally prematication. The PDF micing of casification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you deale specific acreeliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Wher general information on your responsibilities under the Act may be obtained from the Other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (000) 050 2017 61 (a.qov/cdrh/dsma/dsmamain.html

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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NIHON KOHDEN AMERICA

G. Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Cardiofax V ; ECG-1500A series Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

B.B.maritana

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

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).