CARDIO-CARD INTERPRETATION SYSTEM I by NASIFF ASSOC., INC.

The Cardio-Card interpretation program analyzes and reports abnormal and normal ECGs and possible classifications of what kind of abnormals may have been detected from ECG data sent to it. The ECG statements reported assist the user in knowing what problems may exist in the ECG. These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable.

It is intended to be used by or on the order of a physician or similarly qualified health care professional in any environmental setting that the ECG acquisition device is suitable for. These environments include hospitals, physician offices, and clinical settings.

It is intended to be used on the adult patient population.

Device Description

Cardio-Card Interpretive System I

AI/ML Overview

This is a 510(k) clearance letter from the FDA for a device called "Cardio-Card Interpretation System I". This type of letter generally does not contain detailed study information, acceptance criteria, or performance metrics. It primarily states that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, based on the provided text, I cannot extract the requested information. The document focuses on regulatory approval and provides indications for use, but no specific performance study data, acceptance criteria, sample sizes, expert qualifications, or ground truth details.

Here's a breakdown of why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: Not present in the document.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present in the document.
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 present in the document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present in the document.
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 present in the document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "automated analysis" and states "These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable," implying it's not standalone or requires human oversight. However, no specific study proving this or measuring standalone performance is provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present in the document. It only states the system "analyzes and reports abnormal and normal ECGs and possible classifications."
The sample size for the training set: Not present in the document.
How the ground truth for the training set was established: Not present in the document.

To obtain this information, one would typically need to refer to the full 510(k) submission (if it's publicly available and unredacted), or scientific publications related to the device's validation.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2000

Roger E. Nasiff, Ph.D. Nasiff Associates, Inc. P.O. Box 88 Brewerton, NY 13029

Re: K993616 Cardio-Card Interpretation System I Requlatory Class: III (three) Product Code: 74 LOS Dated: February 2, 2000 Received: February 4, 2000

Dear Dr. Nasiff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Roger E. Nasiff, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

ficmJA wutermhe r for,

James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name: Cardio-Card Interpretive System I

Indications For Use:

It is intended to be used on the adult patient population.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number __

Regulation Number and Section

N/A