Soft tissue cutting & coagulation
Intraepithelial neoplasia
Condylomata acuminata
Misc. Iesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

Device Description

The Gynex Electrodes are made of thin 0.18mm hard tungsten wire with a high melting temperature and excellent conductiveness of electric current. The electrodes are available in three different styles intended for use in two different types of electrosurgical procedure. The three styles are curved wire loop electrodes, square wire loop electrodes and ball-type electrodes. The two intended uses are excisional procedures (wire loop) and fulguration or coagulation procedures (ball electrode).

All electrode styles consist of an insulated conductive metallic shaft of varing length terminating in a bare metalic "ball" a "square wire loop" or a "curved wire loop". The wire loop electrodes vary in both width and depth of the loop. Electrode shaft diameter is constant at 2,5mm.

AI/ML Overview

The provided document is a 510(k) premarket notification for Gynex Electrodes, a gynecologic electrocautery device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as typically found for novel AI/ML devices.

Therefore, the information required to answer your specific questions about acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not present in this document.

However, I can extract information related to the comparison with the predicate device, which serves as the basis for demonstrating equivalence in a 510(k) submission.

Here's a breakdown of the available information in the context of your questions, explaining why certain sections are not applicable:

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

Not Applicable in this context. For a 510(k) submission of a traditional medical device like electrocautery electrodes, "acceptance criteria" and "reported device performance" are typically demonstrated through comparison to a legally marketed predicate device rather than through a novel performance study with specific metrics like sensitivity, specificity, etc., as would be expected for an AI/ML device. The "acceptance criteria" here is substantial equivalence to the predicate.

The comparison table provided in the document (Section 11) is the closest equivalent, demonstrating how the Gynex Electrodes are substantially equivalent to the predicate device (Cooper Surgical Single-Use Wire Electrodes) across various features.

Feature	Gynex Disposable Electrodes	Predicate Device (Cooper Surgical Single-Use Wire Electrodes)	Substantially Equivalent (SE)?
Intended Use	Soft tissue cutting & coagulation, Intraepithelial neoplasia, Condylomata acuminata, Misc. lesions (polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon)	Same	YES
Design	Tugnsten wire, Curved loop, Square loop, Brass ball electrode	Tugnsten wire, Curved loop, Square loop, Brass ball electrode	YES
Sterile	Yes	Yes	YES
Sizes	Various curved, square, and ball electrodes (listed)	Various curved, square, and ball electrodes (listed), plus additional sizes	YES
Material	Tungsten wire, Stainless steel, Brass, Teflon	Tungsten wire, Stainless steel, Brass, Teflon	YES
Origin	Europe	Europe	YES
Manufacturer	Gynex Corporation	Cooper Surgical	YES
Product Code	HGI	HGI	YES
K - Number	Pending	K952483	YES

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 document describes a medical device (electrodes) that falls under a 510(k) submission. It does not involve a diagnostic AI/ML algorithm that would typically require test sets or data provenance in the way your question implies. The "study" is primarily a physical and functional comparison to a predicate device.

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. As above, there is no "test set" and thus no need for experts to establish ground truth as would be relevant for an AI/ML diagnostic algorithm.

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

Not Applicable. No test set requiring expert adjudication is involved.

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. This is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance would be performed.

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

Not Applicable. This is not an AI/ML device.

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

Not Applicable. The "ground truth" equivalent in a 510(k) for a device like this is the established performance and safety profile of the legally marketed predicate device. The comparison demonstrates that the new device shares fundamental scientific technology, design, materials, and intended use with this predicate, implying equivalent safety and effectiveness.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

In summary: The provided document is a regulatory submission (510(k)) for a conventional medical device (electrocautery electrodes). The criteria you've asked about are specifically designed for evaluating Artificial Intelligence/Machine Learning (AI/ML) medical devices, which operate under different regulatory and evidentiary standards than the device described in this 1999 filing. This document demonstrates substantial equivalence to a predicate device based on design, materials, intended use, and performance characteristics, rather than through a clinical performance study with AI-specific metrics.

Summary

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K982739

3/12/99

Summary of Safety and

Effectiveness Information Premarket Notification, Section 510(k) Gynex Electrodes

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

Device Name: 1.

Trade Name: Gynex Electrodes Common Name: cutting & coagulation electrodes Classification Name: electrocautery, Gynecologic and accessories

Establishment Name & Registration Number: 2.

GYNEX Corporation Name: Number: 3032109

3. Classification:

& 878.4120 Electrocautery, Gynecologic and accessories. (a) Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables. (b) Classification. Class II (performance standards).

Device Class: Class II

Classification Panel: OB/GYN

Product Code: HGI

4. Preamendments Device:

Cooper Surgical; Single-Use Tungsten Wire LEEP Electrodes, Sterile, K952483

Gynex Corporation Device

Curved electrode: 12cm x 1cm x 0.7cm Curved electrode: 12cm x 1cm x 1cm Curved electrode: 12cm x 1.5cm x 0.5cm Curved electrode: 12cm x 1.5cm x 0.7cm Curved electrode: 12cm x 2cm x 0.8cm Curved electrode: 12cm x 2cm x 1cm Square electrode: 12cm x 1cm x 1cm Square electrode: 5.5cm x 1cm x .64cm Ball electrode: 12cm x 5mm Ball electrode: 5.5cm x 5mm

Equivalent Cooper Surgical Device

ltem #R1007 ZL: 12cm x 1cm x 0.7cm ltem #R1010 ZL: 12cm x 1cm x 1cm ltem #R1505 ZL: 12cm x 1.5cm x 0.5cm ltem #R1507 ZL: 12cm x 1.5cm x 0.7cm Item #R2008 ZL: 12cm x 2cm x 0.8cm item #R2010 ZL: 12cm x 2cm x 1cm ltem #S1010 ZL: 12cm x 1cm x 1cm ltem #S1007 ZL: 5.5cm x 1cm x 7.0mm ltem #B0512 ZL: 12cm x 5mm Item #B0555 ZL: 5.5cm x 5mm

5. Device Description:

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electrodes. The two intended uses are excisional procedures (wire loop) and fulguration or coagulation procedures (ball electrode).

6. Applicant Name & Address:

GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052

7. Company Contact:

Mr. Steve Angelo, President GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052 425.882.1179 * 425.895.0115 - fax

8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

9. Voluntary Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, GYNEX Corporation. Standard Operating Procedures (SOP), vendor certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality requiations.

10. Storage, Packaging & Sterilization Information:

Gynex brand Electrodes are supplied "STERILE". The sterilization method is EtO gas sterilization and the exposure cycle has been validated to achieve a sterility assurance level of 10°. The sterilization process, the validation procedure and the nature of the gas residuals are conducted and characterized in accordance with ANSI/AAMI/ISO 11135 -1994; EN550: 1994; AAMI method designation EOR; ISO/DIS 10993-7.2; FDA Proposed "Maximum Residue Limits and Maximum Exposure" and the Pharmacopeia of the United States.

Packaging materials are typical medical grade peel-type pouches of the generic mylar/nonwoven sandwich variety. All packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. Any shipping damaged product should be returned promptly. Sterile product must be handled, opened and placed into use following accepted sterile technique.

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Comparison Table: 11.

FEATURE	Gynex Disposable Electrodes	Cooper Surgical Single-Use WireElectrodes	SE?
Intended Use:	Soft tissue cutting & coagulationIntraepithelial neoplasiaCondylomata acuminataMisc. lesions; polyps, molluscumcontagiosum, nevi, seborrheic keratosis,achricordon	Same	YES
Design:	Tugnsten wireCurved loopSquare loopBrass ball electrode	Tugnsten wireCurved loopSquare loopBrass ball electrode	YES
Sterile:	Yes	Yes	YES
Sizes:	Curved electrode: 12cm x 1cm x 0.7cmCurved electrode: 12cm x 1cm x 1cmCurved electrode: 12cm x 1.5cm x 0.5cmCurved electrode: 12cm x 1.5cm x 0.7cmCurved electrode: 12cm x 2cm x 0.8cmCurved electrode: 12cm x 2cm x 1cmSquare electrode: 12cm x 1cm x 1cmSquare electrode: 5.5cm x 1cm x 6.4mmBall electrode: 12cm x 5mmBall electrode: 5.5cm x 5mmShaft diameter 2.5mm	Curved electrode: 12cm x 1cm x 0.7cmCurved electrode: 12cm x 1cm x 1cmCurved electrode: 12cm x 1.5cm x 0.5cmCurved electrode: 12cm x 1.5cm x 0.7cmCurved electrode: 12cm x 2cm x 0.8cmCurved electrode: 12cm x 2cm x 1cmSquare electrode: 12cm x 1cm x 1cmSquare electrode: 5.5cm x 1cm x .7cmBall electrode: 12cm x 5mmBall electrode: 5.5cm x 5mmplus additional size square, ball and needle-type electrodesShaft diameter 2.5mm	YES
Material:	Tungsten wireStainless steelBrassTeflon	Tungsten wireStainless steelBrassTeflon	YES
Origin:	Europe	Europe	YES
Manufacturer:	Gynex Corporation	Cooper Surgical	YES
Product Code:	HGI	HGI	YES
K - Number:	Pending	K952483	YES

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with three parallel lines above them, possibly representing wings or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1999

Gynex Corporation c/o Mr. David W. Schlerf Official Correspondent BUCKMAN Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 Re: K982739

GYNEX Electrodes Dated: November 20, 1998 Received: February 24, 1999 Regulatory Class: II 21 CFR 878.4120/Procode: 85 HGI

Dear Mr. Schlerf:

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.

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) 594-4613. 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _1 __ of __ 1

510(k) Number: K982739

Device Name(s):

GYNEX Electrodes

Intended Use of the Device:

1. Soft tissue cutting & coagulation
1. Intraepithelial neoplasia
1. Condylomata acuminata
1. Misc. Iesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Segerson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_

Prescription Use X
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)

GYNEX-ELECTRODES.doc

Regulation Number and Section

§ 884.4120 Gynecologic electrocautery and accessories.

(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).