The Hook Electrode is a unipolar electrosurgical device used primarily for cutting, but also usable for coagulation. The device is attached via cable to an electrosurgical generator.

AI/ML Overview

The provided document K964329 describes a 510(k) submission for a Unipolar Electrosurgical Hook Electrode. This device is not a software-driven AI/ML device, and therefore, many of the requested criteria related to AI/ML device performance and study design are not applicable.

Here's an analysis based on the information provided, highlighting the non-applicability of certain AI/ML-specific questions:

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

Acceptance Criteria	Reported Device Performance
3000 Volt isolation	Tested to assure 3000 volt isolation
Validation to recommended sterilization processes (gas and steam sterilizable)	Validated to recommended sterilization processes
Durability of powder coating	Mentioned as a "Technological Characteristic" but no specific performance metric or acceptance criteria is provided.
Safety and Effectiveness based on instruction manual	Designed and tested to guarantee safety and effectiveness when used according to the instruction manual.

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

Not Applicable: This device is a physical electrosurgical hook electrode. The "test set" in an AI/ML context refers to a distinct dataset used for evaluating algorithm performance. For this device, "testing" refers to physical compliance testing.
The performance data focuses on technical characteristics rather than a clinical "test set" in the AI/ML sense.

3. 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: Given this is a physical medical device, there is no "ground truth" in the context of expert labels for an AI/ML system. Ground truth typically refers to verified labels or annotations for data used to train and evaluate AI models. The "ground truth" of performance for this device comes from engineering and material testing standards.

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

Not Applicable: Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses in clinical studies, particularly for AI/ML development. This device's evaluation does not involve such human-in-the-loop expert adjudication of a test set.

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 Applicable: MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, on diagnostic tasks using medical images or other data. This device is an electrosurgical tool and does not involve "human readers" interpreting data with or without AI assistance.

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

Not Applicable: There is no algorithm associated with this physical electrosurgical device, so standalone algorithm performance testing is irrelevant.

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

Engineering Standards / Physical Property Measurement: The "ground truth" for this device's performance is based on established engineering standards for electrical isolation and validated sterilization protocols. For example, "3000 Volt isolation" would be verified through specific electrical tests.

8. The sample size for the training set

Not Applicable: This is not an AI/ML device. There is no concept of a "training set" for physical electrosurgical tools.

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

Not Applicable: As there is no training set for an AI/ML model, there is no ground truth establishment for a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided 510(k) summary states that "Performance Data" was "Tested to assure 3000 volt isolation and validation to recommended sterilization processes." Additionally, it notes the device's "Technological Characteristics" include a "durable powder coating" and that it is "gas and steam sterilizable."

No Clinical Tests: The document explicitly states "No clinical tests performed."

Conclusion: The device's safety and effectiveness were demonstrated through engineering and performance testing against established standards for electrical isolation and sterilization, rather than through clinical trials or AI/ML specific performance studies. The substantial equivalence claim is based on the device's design, intended use, and technological characteristics being comparable to pre-enactment and existing predicate devices, along with the successful completion of these non-clinical performance tests.

Summary

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K964329

MAY 2 | 1997

510(k) Summary of Safety and Effectiveness
Submitter:
Company / Institution name:	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Date of Preparation	October 25, 1996
Division name (if applicable):	N.A.
FDA establishment registration number:	14 184 79
Street address:	353 Corporate Woods Parkway
Phone number (include area code):	(847) 913-1113
City:	Vernon Hills
State/Province:	Illinois
Country:	USA
ZIP / Postal Code:	60061
FAX number (include area code):	(847) 913-0924
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager
Product Information:
Trade name:	Unipolar Electrosurgical Hook Electrode
Model number:	8383.423, 8384.423
Common name:	Hook Electrode
Classification name:	Electrosurgical cutting and coagulation device and accessories
Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name	Manufacturer
1 pre-enactment	1 Hook Electrode 8383.42	1 Richard Wolf Medical Instruments
2 existing device	2 Hook Electrodes 8383.423, 8384.423	2 Richard Wolf Medical Instruments
3	3	3

1.0 Description

The Hook Electrode is a unipolar electrosurgical device used primarily for cutting, but also usable for coagulation. The device is attached via cable to an electrosurgical generator.

2.0 Intended Use

The electrosurgical unipolar hook electrode is intended to be used for coagulation and cutting of tissue.

Technological Characteristics 3.0

· durable powder coating
· 3000 Volt isolation
gas and steam sterilizable .

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Substantial Equivalence 4.0

The basic design of the hook electrode is equivalent to pre enactment devices from R.Wolf and equivalent to existing competitive devices.

5.0 Performance Data

Tested to assure 3000 volt isolation and validation to recommended sterilization processes.

Clinical Tests 6.0

No clinical tests performed.

Conclusions Drawn 7.0

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.

By:

Robert J. Casanova

Robert L. Casarsa Quality Assurance Manager

Date: Oct 25, 1996

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its wings spread and head facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 1997

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

Re: K964329 Trade Name: Electrosurgical Hook Electrodes Regulatory Class: II Product Code: GEI Dated: April 18, 1997 Received: April 22, 1997

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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/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

Enclosure

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K 964329 510(k) Number (if-known):

ELECTOSURGICAL HOOK ELECTRODES Device Name: __

Indications For Use:

(PER 21 CFR 601.109)

The electrosurgical unipolar hook electrode is used for coagulation and cutting of tissue.

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

(Division Sign-Off)
Division of General Restorative Devices	K964329
510(k) Number

PRESCRIPTION USE	OR	OVER-THE-COUNTER USE_
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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.