There are two models of the NESSY Ω™ (Omega) Disposable Split Return Electrode, One with a connecting cable (P/N: 20193-084) and the other (P/N: 20193-085) without the cable {Note: A reusable patient return electrode cable submitted in a previous ERBE 510(k) [K960569] is used with this plate/pad}. The cable of the P/N: 20193-084 is made of Polyvinvlcholoride (PVC). Copper Wiring, and Polyethylene (PE) Foam. It is flexible, 4 m (13.2 ft.) long, and has a standard connection for fitting into an ESU. The pad portion of each is made of Siliconized Polyethylene Terephthalate (PET). Scantape coated with Acrylic Adhesive, Aluminum, and Hydrogel. There is a protective film cover to keep the pad from drying out prior to being used. The Return Electrode has a peel off tab that makes handling it easier. The plate also is flexible and molds well to the skin. The relatively round external shape and geometrical internal omega design (i.e., the equipotential ring) of the pad more uniformly distributes the High Frequency (HF) current. This was demonstrated through thermographic testing. The design also eliminates the need for orientating the pad to the operative site (i.e., there is no long side of the pad). The hydrogel layer overlaps all the aluminum edges, which reduces warming of the pad during use. The Patient Plate is suitable for use on children and adults. The Electrodes are each packaged in an aluminum foil pouch with a 2-year expiration date. Also, they are provided non-sterile and are disposable.

AI/ML Overview

The provided text describes a 510(k) summary for the NESSY Ω™ (Omega) Disposable Split Return Electrode. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the way a clinical trial for a novel AI device might.

Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set size) are not applicable or cannot be extracted from this type of regulatory submission. The document mainly outlines the device's technical specifications, intended use, and its similarities and differences to a legally marketed predicate device, along with the standards it met.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a new AI device. Instead, the "acceptance criteria" can be inferred as demonstrating substantial equivalence to a predicate device by meeting relevant electrical safety and biocompatibility standards. The reported "performance" relates to how the new device achieves this equivalence.

Acceptance Criteria (Inferred)	Reported Device Performance
Safety and Effectiveness (Substantial Equivalence)	The modified Split Return Electrodes have the same intended use and principles of operation as the Split Return Electrodes in the previously cleared predicate device. Technologically, the modified electrode's round/omega design of the pad's conductive films disperses HF current more evenly. As a result, the NESSY Ω™ (Omega) Disposable Split Return Electrodes are as safe and effective as the predicate device.
Material Biocompatibility	"The materials have been found acceptable through biocompatibility testing. Tests were selected based upon EN ISO 10993-1, 'Biological Evaluation of Medical Devices'."
Electrical Safety and Performance Standards Adherence	"Applicable sections of AAMI/ANSI HF-18, 'Electrosurgical Devices'; EN/IEC 60601-1, 'Medical Electrical Equipment, General Requirements for Safety, and EN/IEC 60601-2-2, 'Medical Electrical Equipment, Particular Requirements for the Safety of High Frequency Surgical Equipment' standards were applied and met for the modified Split Return Electrodes."
Uniform Distribution of High-Frequency (HF) Current	"The relatively round external shape and geometrical internal omega design (i.e., the equipotential ring) of the pad more uniformly distributes the High Frequency (HF) current. This was demonstrated through thermographic testing." (Applies to the design principle rather than direct performance measurement in a clinical study context).
Reduced Warming of the Pad	"The hydrogel layer overlaps all the aluminum edges, which reduces warming of the pad during use."
Packaging and Expiration Dating Robustness	Same packaging and expiration dating as the predicate device (2-year expiration date confirmed).
Mechanical Properties (Flexibility, Adhesion, Handling)	"The pad portion... made of Siliconized Polyethylene Terephthalate (PET), Scantape coated with Acrylic Adhesive... is flexible and molds well to the skin." "The Return Electrode has a peel off tab that makes handling it easier."

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

This information is not provided in the 510(k) summary. The document mentions "thermographic testing" and "biocompatibility testing" but does not detail the sample sizes for these tests. In a 510(k) for a device like this, the focus is on engineering verification and validation against standards rather than large-scale clinical trials with specified clinical data provenance.

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)

This information is not provided and is generally not applicable to the type of device and regulatory submission described. "Ground truth" in this context would likely refer to established engineering standards or validated test methods, rather than expert clinical consensus on patient data.

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

This information is not provided and is not applicable to the engineering and bench testing described in the document.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the NESSY Ω™ electrode is.

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

This is not applicable as the NESSY Ω™ electrode is not an algorithm or AI-powered device. It is a physical medical device.

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

For the verification and validation tests mentioned, the "ground truth" would be based on:

Established engineering standards: AAMI/ANSI HF-18, EN/IEC 60601-1, EN/IEC 60601-2-2 for electrical safety and performance.
Biocompatibility testing against a standard: EN ISO 10993-1.
Physical and thermal measurements: Thermographic testing for current distribution and warming, mechanical testing for flexibility and adhesion.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

Summary

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NOV 2 9 2002

	510K SUMMARY
	K023812
Submitted By:	ERBE USA, Inc.
	2225 Northwest Parkway
	Marietta, GA 30067
	Tel: 770-955-4400
	Fax: 770-955-2577
Contact Person:	John Tartal
Date Prepared:	11/14/02
Common Name:	Patient Plate/Pad, Dispersive Electrode, or Return Electrode
Trade/Proprietary Name:	NESSY Ω TH (OMEGA) Disposable split Return Ele
Classification Name:	Electrosurgical cutting and coagulation device and
	accessories (21CFR878.4400)
Product Code:	79GEI
Legally Marketed Device:	ERBE Disposable Patient Return Electrodes, 510(k)
	Number: K972269

Device Description:

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510K SUMMAR

Prior to electorsurgery, the NESSY Ω™ (Omega) Disposable Split Return Electrode is placed on the patients skin. AORN (Association of Operating Room Nurses) guidelines are to be followed for site selection, preparation of the site, etc. The Patient Plate is then attached via a connecting cable to an Electrosurgical Unit (ESU) or Generator. When the ESU is activated, the pad safely returns (disperses) the HF current. If the Generator has a safety monitoring system, the ESU measures the current going into and exiting the pad. In this manner, the Generator monitors the HF current and alerts the clinician to any differences.

Intended Use:

NESSY Ω™ (Omega) Disposable Split Return Electrodes are intended for dispersing and monitoring HF current in electrosurgical interventions.

Similarities and Differences of the Modified Device to the Current Device (Predicate Comparison/Substantial Equivalence):

Similarities

The modified Split Return Electrodes have intended use, performance expectations (i.e., safely dispersing/returning delivered HF current and, with the previous split return models, monitoring the current), packaging, and associated labeling as the predicate. As with the predicate, the Patient Plate/Pad comes with or without a connecting cable. Also like the predicate, they are provided non-sterile with the same expiration dating and are disposable.

Finally, the contract manufacturer for the Return Electrodes is the same (Leonhard Lang GmbH).

Differences

The material changes in the modified Split Return Electrode basically involve the pad's carrier being made of Scantape with Acrylic Adhesive (Note: The fabric in band aids.) which molds better to the body and an improved Hydrogel (NH-02). The materials have been found acceptable through biocompatibility testing. Tests were selected based upon EN ISO 10993-1, "Biological Evaluation of Medical Devices".

For the modified Electrode with a cable, the cord is 1 m (3.3 ft.) longer than the predicate devices that have a cable [i.e., the predicate device cable is 3 m (10 ft.) long in comparison to 4 m (13 ft.) for the modified product that has a cablel. The extra length provides the clinician with a little more latitude in regards to the position of the patient and equipment location.

The pad of the modified Split Return Electrodes, are designed with an equipotential ring. The round/omega design of the conductive films distributes HF current more evenly. As a result, only one size pad (i.e., contact surface) is needed. Also, due to the symmetrical design of the plate, there is no long side. Therefore, no orientation of the pad to the operative site is needed.

{2}------------------------------------------------

510K SUMMARY

K023812

All the changes have been verified or validated in design control. Applicable sections of AAMI/ANSI HF-18, "Electrosurgical Devices"; EN/IEC 60601-1, "Medical Electrical Equipment, General Requirements for Safety, and ENVIEC 60601-2-2, "Medical Electrical Equipment, Particular Requirements for the Safety of High Frequency Surgical Equipment" standards were applied and met for the modified Split Return Electrodes.

Conclusion:

The modified Split Return Electrodes have the same intended use and principles of operation as the Split Return Electrodes in the previously cleared predicate device. Technologically the modified electrode's round/omega design of the pad's conductive films disperses HF current more evenly. As a result, the NESSY Ω™ (Omega) Disposable Split Return Electrodes are as safe and effective then the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

9 9 2002

Erbe USA. Inc. John Tartal QA/RA. Manager 2225 Northwest Parkway Marietta, Georgia 30067

Re: K023812

Trade/Device Name: Nessy Ώ™ (Omega) Disposable Split Return Electrodes Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 14, 2002 Received: November 15, 2002

Dear Mr. Tartal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the

{4}------------------------------------------------

Page 2 - Mr. John Tartal

quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

iriam C. Provost

{0' Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) NUMBER (IF KNOWN): K023812
DEVICE NAME: NESSY ΩΤΜ (Omega) Disposable Split Return Electrodes
INDICATIONS FOR USE:

NESSY Ω™ (Omega) disposable split return electrodes are intended for dispersing and monitoring HF current in electrosurgical interventions.

Muriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

K023812

(PLEASE DO NOT MRITE BELOW THIS LINE-CONTINUE ON ANOTHER E IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODD)

Prescription Use (Per 21 CER 001.109)

Over-The-Counter-(Optional Forma

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.