The Micromedical™ 12 Lead Simultaneous Cable is intended for use in acquiring a patient ECG signal via 10 leads connected to the patient's chest, converting the ECG patient DOO siguir 11-2-2, and transferring this information to a Micromedical™ monitor using a proprietary digital data transfer protocol.

Device Description

The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical™ monitor.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way described in the prompt's request. The document is a 510(k) summary for a 12-Lead Simultaneous Cable, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed metrics against pre-defined acceptance criteria.

However, I can extract the available information and highlight what is missing based on your request.

Missing Information:

The provided text does not include the following details that are typically found in a detailed performance study:

A table of specific acceptance criteria (e.g., signal-to-noise ratio, frequency response, accuracy of parameter measurements).
Reported device performance against those specific criteria.
Sample size used for a test set (beyond "non-clinical testing").
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications for ground truth establishment.
Adjudication method for a test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of AI assistance on human readers.
Specific details of a standalone (algorithm only) performance study.
The specific type of ground truth used (e.g., expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Based on the available text, here's what can be inferred/extracted:

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

The document states: "Non-clinical testing was performed to compare the device to the predicate device. Testing showed the proposed device to be substantially equivalent to the predicate device."

Acceptance Criteria (Inferred): Substantial equivalence to the predicate device (MAX 1 Exercise Testing System) regarding its function of acquiring and transmitting ECG signals. The specific quantitative criteria for this equivalence are not detailed.
Reported Device Performance: The device was found to be "substantially equivalent" to the predicate device. No specific numerical performance metrics are provided.

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

Test Set Sample Size: Not specified. The document only mentions "Non-clinical testing."
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 applicable as no specific human expert review for establishing ground truth is mentioned for performance evaluation. The comparison is against a predicate device's expected performance.

4. Adjudication method for the test set:

Not applicable/Not specified, as no human expert review process is described.

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, this type of study was not mentioned. The device is a cable for acquiring and transmitting ECG signals, not an AI-powered diagnostic tool.

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

The device itself is a physical cable. Its "performance" would be related to signal integrity and transmission accuracy, which were presumably assessed in non-clinical standalone tests, but details are not provided. There's no AI algorithm involved.

7. The type of ground truth used:

The ground truth implicitly used is the performance of the legally marketed predicate device (MAX 1 Exercise Testing System), against which the new device demonstrated "substantial equivalence." The specific metrics from the predicate device that served as ground truth are not detailed.

8. The sample size for the training set:

Not applicable. The device is a physical cable, not a machine learning model that requires a training set.

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

Not applicable.

Summary

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K97430

AUG 25 1998 -

510(k) SUMMARY

Submitted by:

Malcom Castle, President Micromedical, Inc. 255 Revere Drive Suite 111 Northbrook, IL 60062

Date Prepared:

October 19, 1997

Proposed Device:

12 Lead Simultaneous Cable

Predicate Device:

MAX 1 Exercise Testing System

Proposed Device Description:

The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical™ monitor.

Statement of Intended Use;

The 12 Lead Simultaneous Cable acquires a patient's ECG via 10 leads connected to a patient's chest, converts the ECG signal into a digital format, and transfers this information to a Micromedical™ monitor using a proprietary digital data transfer protocol.

The proposed device is intended to be used to acquire a patient's ECG signal and transmit it to a Micromedical™ monitor.

Discussion of Non-Clinical Tests; Conclusions Drawn from Non-Clinical Tests

Non-clinical testing was performed to compare the device to the predicate device. Testing showed the proposed device to be substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem 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 curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1998

Mr. Malcom Castle President Micromedical, Inc. 255 Revere Drive, Suite 111 Northbrook, IL 60062

Re: K974220 12-Lead Simultaneous Cable Requlatory Class: II (two) Product Code: DPS Dated: August 13, 1998 Received: August 19, 1998

Dear Mr. Castle:

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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any

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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 requlations.

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? (21CFR 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

K974220 510(k) Number:

Device Name:

Micromedical™ 12 Lead Simultaneous Cable

Indication for Use:

Prescription Use
(Per 21 CFR 801.109)

V. Dale Tull

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

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).