The Smith & Nephew ElectroThermal® 20S Spine System is intended to create lesions in nervous tissue, and to coagulate and decompress disc material when used in combination with Smith & Nephew thermal/coagulating probes. The generator and accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Description

The proposed Smith & Nephew ElectroThermal® 20S Spine generator is a 20-watt electrothermal generator. It is intended to be used to create lesions in nervous tissue and to coagulate and decompress material when used in combination with Smith & Nephew thermal/coagulating probes. The generator provides temperature and impedance monitoring of energy to maintain effective tissue heating during temperature controlled applications. Smith & Nephew ElectroThermal® 20S Spine generator is designed to be used in conjunction with Smith and Nephew Spine products. These products include the Smith & Nephew SpineCATH® Intradiscal Catheter, the Smith & Nephew Decompression Catheter and the Smith & Nephew RF Denervation Probe and Smith & Nephew RF Probe.

AI/ML Overview

The provided document is a 510(k) summary for the Smith & Nephew ElectroThermal® 20S Spine Generator, which details its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the manner of a clinical trial for diagnostic performance.

Therefore, the detailed information requested regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in this document, as it pertains to performance studies typically conducted for devices with diagnostic or AI components. This submission is for an electrosurgical generator, and the "performance data" referred to is about its functional equivalence to other similar generators.

Here's an interpretation of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence based on technological characteristics and functional performance compared to predicate devices. The "reported device performance" is the demonstration of this substantial equivalence.

Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (Summary)
Control and monitor temperature (like ORA-50 S and RFG-3C Plus)	The Smith & Nephew ElectroThermal® 20S Spine Generator controls and monitors temperature.
Monitor impedance (like ORA-50 S and RFG-3C Plus)	The Smith & Nephew ElectroThermal® 20S Spine Generator monitors impedance.
Use RF energy to thermally heat SpineCATH® and Decompression catheters (like ORA-50 S)	The Smith & Nephew ElectroThermal® 20S Spine Generator uses RF energy to thermally heat the SpineCATH® and Decompression catheters.
Provide preset settings for time and temperature to deliver RF (like ORA-50 S)	The Smith & Nephew ElectroThermal® 20S Spine Generator provides preset settings for time and temperature to deliver RF.
Use a biphasic square wave to deliver stimulation voltage (like RFG-3C Plus)	The Smith & Nephew ElectroThermal® 20S Spine Generator uses a biphasic square wave to deliver stimulation voltage.
Use temperature controlled RF energy to create lesions in nervous tissue (like RFG-3C Plus)	The Smith & Nephew ElectroThermal® 20S Spine Generator uses temperature-controlled RF energy to create lesions in nervous tissue.
Deliverance of temperature and time of RF controlled energy (overall functional performance)	"The performance testing conducted on the Smith & Nephew ElectroThermal® 20S Spine generator demonstrates substantial equivalents to the Radionic's RFG-3C Plus Lesion Generator clarified in K982489 and the Smith & Nephew ORA-50 S clarified in K993854 based on deliverance of temperature and time of RF controlled energy." (This indicates the device functionally performs these tasks comparably to the predicate devices.)

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

Not Applicable. This document describes a 510(k) submission for an electrosurgical generator, focusing on its substantial equivalence to predicate devices based on technological characteristics and functional performance rather than diagnostic accuracy or clinical outcomes tested on a "test set" of patient data. Performance testing would typically involve engineering and bench testing to confirm the generator's output parameters match those of the predicate, not a "test set" of patient data in the context of diagnostic AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant here as this is an electrosurgical device. The "ground truth" for its functional performance would be established by engineering specifications and measurements.

4. Adjudication method for the test set

Not Applicable. See point 3.

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 device is an electrosurgical generator, not an AI-powered diagnostic tool. MRMC studies are for diagnostic accuracy, typically involving human readers interpreting images with or without AI assistance.

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

Not Applicable. This is not an algorithm but an electrosurgical device. Its performance is evaluated through engineering and functional tests.

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

Implied Ground Truth: For this type of device, the "ground truth" for its performance would be established through engineering specifications, bench testing, and functional measurements to ensure that the device generates the correct RF energy, monitors temperature and impedance accurately, and performs its intended electrosurgical functions within established parameters that are comparable to the predicate devices. This is not derived from clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of an electrosurgical generator. This terminology applies to machine learning algorithms.

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

Not Applicable. See point 8.

Summary

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Endosconv contin & Nephew, in 150 Minuteman Road Andover MA 01810

ww smith-nephew com

KO33981

SECTION V 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew ElectroThermal® 20S Spine Generator

Date Prepared: December 22, 2003

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

B. Company Contact

Janice Haselton Regulatory Affairs Specialist II Phone: (978) 749-1494 (978) 749-1443 Fax:

C. Device Name

Trade Name:	Smith & Nephew ElectroThermal® 20S Spine Generator
Common Name:	Electrosurgical Spine Generator
Classification Name:	Electrosurgical Cutting and Coagulation & Accessories

D. Predicate Devices

The Smith & Nephew Smith & Nephew ElectroThermal® 20S Spine Generator is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew ORA-50 S, cleared in K993854 and Radionic's RFG-3C Plus Lesion Generator, cleared in K982489.

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K033981 (pg 2 of 3)

Description of Device E.

Intended Use F.

Contraindications for Use:

There are no known absolute contraindications to the use of electrosurgery.

The Smith & Nephew ElectroThermal® 20S Spine System is contraindicated, when in the judgement of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.

G. Comparison of Technological Characteristics

The Smith & Nephew ElectroThermal® 20S Spine generator is substantially equivalent to the Smith & Nephew ORA-50 S, cleared in K993854, based on the following:

· Both control and monitor temperature
· Both monitor impedance
· Both use RF energy to thermally heat the SpineCATH® and Decompression catheters
· Both provide preset settings for time and temperature to deliver RF.

The Smith & Nephew ElectroThermal® 20S Spine generator is substantially equivalent to the Radionic's RFG-3C Plus Lesion Generator cleared in K982489 based on the following.

· Both control and monitor temperature
· Both monitor impedance
· Both use a biphasic square wave to deliver stimulation voltage

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· Both use temperature controlled RF energy to create lesions in nervous tissue

H. Summary Performance Data

The performance testing conducted on the Smith & Nephew ElectroThermal® 20S Spine generator demonstrates substantial equivalents to the Radionic's RFG-3C Plus Lesion Generator cleared in K982489 and the Smith & Nephew ORA-50 S cleared in K993854 based on deliverance of temperature and time of RF controlled energy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of an eagle or bird with three wing-like shapes, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird, indicating the department's name and the country it represents.

Public Health Service

FEB 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janice Haselton Regulatory Affairs Specialist II Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusctts 01810

Re: K033981

Trade/Device Name: The Smith & Nephew ElectroThermal® 20S Spine Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: Deccmber 22, 2003 Received: December 23, 2003

Dear Ms. Haselton:

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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. 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 quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Janice Haselton

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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Mark A. Milliken

Cclia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):__K033981

Device Name: The Smith & Nephew ElectroThermal® 20S Spine System

Indications For Use:

The Smith & Nephew ElectroThermal® 20S Spine System is intended to create lesions in nervous tissue, and to coagulate and decompress disc material when used in in nervous tious, and to our ew thermal/coagulating probes. The generator and oombination will be mare by qualified medical personnel trained in the use of electrosurgical equipment.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

for Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510 Number K033981

Page 1 of

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.