The Uni/Monopolar HF Cables are used to direct a high frequency electrical current from an electrical generator made by unspecified manufacturers to a R. Wolf HF instrument.

AI/ML Overview

The provided document does not describe an AI/ML device or a study with typical acceptance criteria as would be found for such a device. Instead, it is a 510(k) summary for a Uni/Monopolar HF Cable, a medical instrument component.

Therefore, most of the requested information regarding AI/ML device performance, sample sizes, ground truth establishment, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

Here's an analysis of what is available, and why other sections are not applicable:

Acceptance Criteria and Reported Device Performance

The document states:

"No known FDA performance standard exists."
"The Monopolar HF Cables were tested to comply with the appropriate sections of ANSI/AAMI standard on high frequency devices, HF18 and IEC601-2-18."
"The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals."

Given the nature of the device (a cable), the acceptance criteria are not presented in a table format with specific performance metrics like sensitivity, specificity, or AUC, as would be expected for an AI/ML diagnostic or prognostic tool. Instead, the acceptance criteria are compliance with recognized electrical safety and performance standards for high-frequency medical devices.

Table of Acceptance Criteria and Reported Device Performance (Best Effort based on available information):

Acceptance Criterion	Reported Device Performance / Assessment
Maximum Recurrent Peak Voltage	Max 4000 Vp (Technological Characteristic)
Sterilization Method	Sterilizable by steam at 134℃ (Technological Characteristic)
Compliance with HF Standards	Tested to comply with ANSI/AAMI HF18 and IEC601-2-18
Safety and Effectiveness	Designed and tested to guarantee safety and effectiveness per instruction manuals

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

Not Applicable / Not Provided. This document describes testing for an electrical cable against engineering standards, not a study involving patient data or a test set in the context of AI/ML evaluation. There is no mention of a "test set" in this context.

2. 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 Applicable. Ground truth, in the AI/ML sense, is not established for this device evaluation. The "ground truth" for a cable would be its adherence to electrical and material specifications, which are verified through engineering tests, not expert consensus on medical images or clinical outcomes.

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

Not Applicable. There is no "test set" and no human expert adjudication as understood in AI/ML validation studies.

4. 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 is a hardware component (a cable), not an AI/ML system. There are no human readers or AI assistance involved in its evaluation as described.

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

Not Applicable. This is a physical, non-algorithmic device.

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

Technical Specifications and Engineering Standards. The "ground truth" for this device's performance is adherence to defined technical specifications (e.g., maximum voltage, sterilization capacity) and compliance with electrical safety standards (ANSI/AAMI HF18 and IEC601-2-18).

7. The sample size for the training set

Not Applicable. This is a hardware component; there is no "training set" as it does not involve machine learning.

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

Not Applicable. As there is no training set, this question is irrelevant.

Summary

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353 Cerporate Woods Parkway Vernon Hills, Illinois 6006 1 Phone: $47.913.1143 Fax: 847.913.1488

AUG 3 1 1998

Image /page/0/Picture/2 description: The image shows the logo for Richard Wolf Medical Instruments Corporation. The text "RICHARD WOLF" is in large, bold, black letters. Below that, in smaller letters, is the text "MEDICAL INSTRUMENTS CORPORATION". The text is left-aligned.

Image /page/0/Picture/3 description: The image contains a series of handwritten digits and a letter. The characters are 'k', '9', '8', '2', '6', and '77'. The characters are written in a dark ink on a white background. The handwriting appears somewhat messy and uneven.

ਸਿੰ

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510(k) Summary of Safety and Effectiveness

Submitter:		Date of Preparation:	July 31, 1998
Company / Institution name:	Richard Wolf Medical Instruments Corp.	FDA establishment regulation number:	14 184 79
Division name (if applicable):	N.A.	Phone number (include area code):	(847) 913-1113
Street address:	353 Corporate Woods Parkway	FAX number (include area code):	(847) 913-0924
City:	Vernon Hills	State/Province:	Illinois
Country:	USA	ZIP/Postal Code:	60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager

Product Information:

Trade name:	Unipolar/Monopolar HF Cable	Model number:	815.xxx, 8106.xxx
Common name:	Unipolar/Monopolar HF Cable	Classification Name:	Uni/Monopolar HF Cable

Information on devices to which substantial equivalence is claimed:

	510(k) Number	Trade or proprietary or model name	Manufacturer
1	K943776	Bipolar Cables 8108	Richard Wolf GmbH
2	pre-enactment	Monopolar Cables 8106, 815	Richard Wolf GmbH
3
4

1.0 Description

The Uni/Monopolar HF Cables are used to direct a high frequency electrical current from an electrical generator made by unspecified manufacturers to a R. Wolf HF instrument.

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2.0 Intended Use

The Uni/Monopolar HF Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.

Technological Characteristics 3.0

TheUni/Monopolar HF Cables may be operated at a maximum recurrent peak voltage of 4000 Vp.

The cables can be sterilized by steam at 134℃.

4.0 Substantial Equivalence

Uni/Monopolar HF Cables 815 and 8106 are substantially equivalent to existing pre-amendment Uni/Monopolar HF Cables 815 and 8106. The material changes have not reduced safety or effectiveness.

5.0 Performance Data

No known FDA performance standard exists.

The Monopolar HF Cables were tested to comply with the appropriate sections of ANSI/AAMI standard on high frequency devices, HF18 and IEC601-2-18.

6.0 Clinical Tests

No clinical tests performed.

7.0 Conclusions Drawn

The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals.

By: Robert J. Casasa

Robert L. Casarsa Quality Assurance Manager

Date: July 29 98

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 1998

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

Re: K982677

Trade Name: Uni/Monopolar HF Cable Regulatory Class: II Product Code: GEI Dated: July 31, 1998 Received: July 31, 1998

Dear Mr. Casarsa:

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 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 Drug 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 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 - Mr. Robert L. Casarsa

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) 594-4595. 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,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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																																							And And Charles

																																							11.0.0

510(k) Number (if known):

K982677

Device Name:

Uni/Monopolar HF Cable

Intended Use:

The Uni/Monopolar High Frequency Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

coll

ative Devices eneral Re

Prescription Use
Per 21 CFR 801.109

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.