The Smith & Nephew RF Denervation Probe is a temperature sensing electrode designed for use in radiofrequency lesion procedures. The RF Denervation Probe is used with a disposable Smith & Nephew RF Cannulae. The Smith & Nephew Denervation Probe is packaged non-sterile for reuse. The Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations, and are packaged sterile for single use.

AI/ML Overview

Based on the provided text, the device in question is the Smith & Nephew RF Denervation Probes & RF Cannulae. The document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed clinical performance data against specific acceptance criteria for a new device.

Therefore, the information for many of your requested points is not present in this document. The existing information primarily relates to electrical safety standards.

Here's what can be extracted:

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

Acceptance Criteria	Reported Device Performance
Electrical safety standards (UL 60601-1)	The device meets the requirements of UL 60601-1 when used in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator.
Electrical safety standards (IEC 60601-1)	The device meets the requirements of IEC 60601-1 when used in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator.
Substantial Equivalence to Predicate Device	The Smith & Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in design, materials, function, and intended use to the predicate device: Smith & Nephew RF Denervation Probes and RF Cannulae (K034012). (This is a regulatory "acceptance criterion" for 510(k) clearance).

2. Sample sized 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 document. The document refers to "Summary Performance Data" which only states compliance with electrical safety standards, not a clinical test set.

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 in the document, as no clinical test set requiring expert ground truth is described.

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

This information is not provided in the document, as no clinical test set requiring adjudication is described.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done (or at least, not reported in this document). The device is a medical instrument (probe and cannula), not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a medical instrument, not an algorithm or AI.

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

This information is not provided as no clinical performance study with a defined ground truth is described. The performance data presented relates to engineering standards (electrical safety).

8. The sample size for the training set

This information is not provided. The document describes a medical device, not a machine learning model, so there is no "training set" in the context of AI.

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

This information is not applicable, as there is no training set for an AI model.

Summary of the Study and Device Proof:

The "study" described in this 510(k) summary is not a clinical performance study in the traditional sense, but rather a demonstration of substantial equivalence to a previously cleared predicate device (Smith & Nephew RF Denervation Probes & RF Cannulae, K034012) and compliance with electrical safety standards.

The device meets the requirements of UL 60601-1 and IEC 60601-1 electrical safety standards when used with a specific generator (Smith & Nephew Electrothermal® 20S Spine System Generator). This compliance serves as the "proof" for these specific acceptance criteria.
The primary "proof" for regulatory clearance is the argument that the new device is substantially equivalent in design, materials, function, and intended use to the predicate device. This argument itself is the "study" for 510(k) purposes, rather than a clinical trial with performance metrics.

Summary

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JUL 2 0 2007

Ko7/300

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

w.smith-nephew.com

We are smith&nephew

Page 1 of 2

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 RF Denervation Probes & RF Cannulae Traditional 510(k)

Date Prepared: May 8, 2007

A. Submitter's Name:

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

B. Company Contact:

Kathy Reddig Regulatory Affairs Specialist Phone: 978-749-1321 Fax: 978-749-1443

C. Device Name

Trade Name:	Smith & Nephew RF Denervation Probe & RF Cannulae
Common Name:	Probe, Radiofrequency Lesion
Classification Name:	Radiofrequency Lesion Probe

D. Predicate Devices

The Smith & Nephew RF Denervation Probe is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew RF Denervation Probes & RF Cannulae (K034012).

E. Description of Device

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71300

F. Intended Use

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The Smith & Nephew RF Denervation Probes and Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

G. Comparison of Technological Characteristics

The Smith and Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in design, materials, function and intended use to the following device cleared for commercial distribution:

Smith & Nephew RF Denervation Probes and RF Cannulae -- K034012

H. Summary Performance Data

The Smith & Nephew Denervation Probes & RF Cannulae meet the requirements of electrical safety standards for UL 60601-1 and IEC 60601-1 when used in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator.

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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 stylized eagle-like symbol with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2007

Smith & Nephew, Inc. % Ms. Kathy Reddig, RAC Regulatory Consultant 150 Minuteman Road Andover, Massachusetts 01810

Re: K071300

Trade/Device Name: Smith & Nephew RF Denervation Probes & RF Cannulae Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: July 2, 2007 Received: July 3, 2007

Dear Reddig:

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 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.

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Page 2 - Ms. Kathy Reddig, RAC

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milburn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Ko. 7/300

Device Name: Smith & Nephew RF Denervation Probes & RF Cannulae

Indications For Use:

Smith & Nephew RF Denervation Probes and RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

Mark N Milferson

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

510(k) Number

Prescription Use ________x (Per 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 882.4725 Radiofrequency lesion probe.

(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).