The Smith & Nephew Vulcan Articular Cartilage Probe is a single-use, monopolar radiofrequency probe which incorporates a pivoting ceramic head with an embedded RF electrode; protective sheath; and integrated cable. It requires a split ground pad and it is designed for use only with the Smith & Nephew Vulcan Generator.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Smith & Nephew Vulcan Articular Cartilage Probe.

Here's a breakdown of the requested information:

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

Acceptance Criteria	Reported Device Performance
Biological Safety	In compliance with ISO 10993-1
Electromagnetic Compatibility	In compliance with ANSI/AAMI HF-18
Electrical Safety	In compliance with IEC 60601-2-2
Sterilization	Will be in compliance with applicable sterilization standards at the time of commercialization
Performance Characteristics (compared to predicate device)	Bench testing confirms substantial equivalence in performance characteristics.

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

The document primarily references bench testing for performance characteristics and compliance with standards. It does not explicitly state a "test set" in terms of patient data or sample size in the clinical sense. The data provenance is not specified beyond "bench testing," which implies laboratory-based studies rather than human or animal studies, and thus no country of origin is relevant for this type of test. The study appears to be prospective in nature, as it's testing a new device against established standards and a predicate device.

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

Not applicable. The reported studies are focused on technical compliance (biological, electrical, electromagnetic safety, and performance equivalence via bench testing) rather than clinical efficacy or diagnostic accuracy requiring expert ground truth.

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

Not applicable, as a test set requiring adjudication in a clinical context is not 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

Not applicable. This device is a monpolor electrosurgical probe, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies involving AI assistance for human readers are not relevant.

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

Not applicable. This device is a surgical instrument. "Standalone" performance as an algorithm is not relevant.

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

For the compliance studies:

Biological Safety: Ground truth is established by the criteria within ISO 10993-1.
Electromagnetic Compatibility: Ground truth is established by the criteria within ANSI/AAMI HF-18.
Electrical Safety: Ground truth is established by the criteria within IEC 60601-2-2.
Performance Characteristics: Ground truth for substantial equivalence is based on the performance of the legally marketed predicate device, the Smith & Nephew Vulcan TAC C II Probe, as determined through bench testing.

8. The sample size for the training set

Not applicable. This device is a medical instrument and does not involve an AI algorithm with a training set.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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K050898

MAY 2 5 2005

Endoscopy

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

278 749 1000 749 1599 Fax www.smith-nephew.com >< We are smith&nephew

SECTION IV 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 Vulcan Articular Cartilage Probe

Date Prepared: December 13, 2004

A. Submitter's Name:

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

B. Company Contact

Karen Provencher Regulatory Affairs Specialist P: 978-749-1365; F: 978-749-1443

C. Device Name

Trade Name:	Smith & Nephew Vulcan Articular Cartilage Probe
Common Name:	Monopolar Electrosurgical Probe
Classification Name:	Device, Electrosurgical Cutting and Coagulation and accessories (per 21 CFR § 878.4400)

Predicate Devices D.

The Smith & Nephew Smith & Nephew Vulcan Articular Cartilage Probe is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: Smith & Nephew Vulcan TAC C II Probe (K003198 formerly owned by Oratec Interventions, Inc.).

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ui Description of Device

E. Intended Use

The Smith & Nephew Vulcan Articular Cartilage Probe is indicated for arthroscopic chondroplasty procedures in the knee, shoulder, wrist, hip, etc.

G. Comparison of Technological Characteristics

The Smith & Nephew Vulcan Articular Cartilage Probe is similar to the Smith & Nephew Vulcan TAC C II Probe in that both devices are monopolar, single use devices. Both probes require a split grounding pad and are designed for use only with the Smith & Nephew Vulcan Generator. The Smith & Nephew Vulcan Articular Cartilage Probe represents a specific indication for use within the scope of the cleared indications for the Smith & Nephew TAC C II Probe. A major technological difference between the two probes is that the Smith & Nephew Vulcan TAC C II Probe is temperature controlled and the Smith & Nephew Vuican Articular Cartilage Probe is power controlled. Bench testing confirms substantial equivalence in performance characteristics.

H. Summary Performance Data

There are no known performance standards or special controls promulgated under section 415 of the Act for this device. The device was tested and found to be in compliance with ISO 10993-1, ANSI/AAMI HF-18 and IEC 60601-2-2. At the time of commercialization, the device will be incompliance with applicable sterilization standards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. The caduceus features a staff with two snakes coiled around it and a pair of wings at the top.

MAY 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith and Nephew Incorporated C/o Mr. J.A. Van Vugt Kema Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914

Re: K050898

Trade/Device Name: Smith and Nephew Vulcan Articular Cartilage Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HRX Dated: May 13, 2005 Received: May 16, 2005

Dear Mr. Vugt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 2017, 11:53 accordance with the provisions of the Federal Food, Drug, de nees mat have been require approval of a premarket approval application (PMA). and Cosmetic (110.) that to nevice, subject to the general controls provisions of the Act. The r ou may, mercrore, mains of the Act include requirements for annual registration, listing of general controls provision 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 it may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA can or tound in the overaling your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast be advised that I Dr o resumes over device complies with other requirements of the Act that I DA has made a acterinalations administered by other Federal agencies. You must or any it catal statutes and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077; adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality bybellio (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. J.A. Van Vugt

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organization of substantial equivalence of your device to a legally promatics notification: "The sults 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 If you dosire specific de rioliance at (240) 276-0115 . Also, please note the regulation entitled, Connect the Ories of Court Court Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.

Sincerely yours,

Rati

Miriam C. Provost, Ph.D. Acting 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): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Smith & Nephew Vulcan Articular Cartilage Probe is indicated for use in arthroscopic chondroplasty procedures in the knee, shoulder, wrist, hip, etc.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

(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)

vision of and, Restorative and Neurol. Jour Devices

sor78

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.