The Smith & Nephew Dyonics® ElectroBlade™ Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The Smith & Nephew Dyonics® ElectroBlade™ Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.

Device Description

The Smith & Nephew Dyonics® ElectroBlade™ Resector combines electrosurgical and shaver technology to provide hemostasis and mechanical cutting in a single instrument.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Smith & Nephew Dyonics® ElectroBlade™ Resector. This submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data, rather than clinical efficacy through comparative studies with human readers or standalone AI performance.

Therefore, many of the requested categories related to clinical studies, AI performance, ground truth establishment for a training set, and expert adjudication are not applicable or cannot be extracted from this document.

Here's a breakdown of the available information:

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

Acceptance Criteria	Reported Device Performance
Safety Standards Adherence:
ANSVAAMI HF18-1993 for Electrosurgical Devices	Device performs as well as the unmodified device.
IEC 601-1(A1 + A2) Medical Electrical Equipment: Part 1 General Requirements for Safety	Device performs as well as the unmodified device.
IEC 601-1-2 Medical electrical equipment Part 1: General Requirements for Safety and Part 2: Collateral standard: Electromagnetic compatibility - Requirements and tests	Device performs as well as the unmodified device.
IEC60601-2-2:1998 for Medical Electrical Equipment (Part2-2): Particular Requirements for the Safety of High Frequency Surgical Equipment	Device performs as well as the unmodified device.
Biocompatibility Standards Adherence:
ANSI/AAMI ISO 10993-1 for Biological evaluation of medical devices - Part 1: Guidance on selection of tests	Device demonstrated to be in compliance.
Sterilization Standards Adherence:
ANSI/AAMI ISO 11135 Validation and Routine control of Ethylene Oxide Sterilization	Device demonstrated to be in compliance.
Intended Use Equivalence:
As compared to predicate devices (7205961 4.5mm Full Radius Bipolar ElectroBlade™ and 7209700 4.5mm Full Radius Elite Bipolar ElectroBlade™)	The modified device (Vulcan™ Compatible ElectroBlade™) has the same technological characteristics and intended use as the predicate devices.

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 document. The submission references adherence to established safety and performance standards for electrosurgical devices, rather than a clinical "test set" with patient data.

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 applicable/not provided. The device is an electrosurgical tool, and its performance evaluation focused on engineering and biocompatibility standards, not on diagnostic accuracy requiring expert interpretation of a "test set."

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

This information is not applicable/not provided.

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 as this device is an electrosurgical cutting and coagulation device, not a diagnostic imaging device typically evaluated with such studies. AI assistance is also not relevant to this device's function.

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

A standalone performance study for an algorithm was not done as this is a physical medical device, not an AI algorithm.

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

The "ground truth" for this device's performance is established by adherence to recognized international and national standards for electrosurgical devices, biocompatibility, and sterilization. This involves engineering testing, material safety assessments, and validation of manufacturing processes, rather than clinical ground truth like pathology or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

This information is not applicable/not provided. The concept of a "training set" is relevant to machine learning/AI algorithms, which this device is not.

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

This information is not applicable/not provided.

Summary

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.IUN 2 0 2003

Exhibit C

K031675

Endoscor

Smith & Nephew Inc 50 Minuteman Road, Andover, MA 01810-1031 U.S.A lephone: 978-749-1000

Smith & Nephew

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 Dyonics® ElectroBlade™ Resector

Date Prepared: May 19,2003

A. Submitter's Name:

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

B. Company Contact

Karen Provencher Regulatory Affairs Specialist 978-749-1365 (phone) 978-749-1443 (fax)

C. Device Name

Trade Name:	Smith & Nephew Dyonics® ElectroBlade™ Resector
Common Name:	Arthroscopic Surgery Blade and Electrosurgical Probe
Classification Name:	Electrosurgical cutting and coagulation device

D. Predicate Devices

The Smith & Nephew Dyonics® ElectroBlade™ Resector is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device(s) in commercial distribution:

7205961 4.5mm Full Radius Bipolar ElectroBlade™ 7209700 4.5mm Full Radius Elite Bipolar ElectroBlade™

Description of Device E.

The Smith & Nephew Dyonics® ElectroBlade™ Resector combines electrosurgical and shaver technology to provide hemostasis and mechanical cutting in a single instrument.

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F. Intended Use

G. Comparison of Technological Characteristics

The Vulcan™ Compatible ElectroBlade™ has the same technological characteristics and intended use as the predicate device, Smith & Nephew Dyonics® ElectroBlade™ Resector.

H. Summary Performance Data

The modified device, performs as well as the unmodified device as demonstrated in the testing performed to the following standards:

ANSVAAMI HF18-1993 for Electrosurgical Devices ●
IEC 601-1(A1 + A2) Medical Electrical Equipment: Part 1 General . Requirements for Safety
IEC 601-1-2 Medical electrical equipment Part1: General Requirements for . Safety and Part 2: Collateral standard: Electromagnetic compatibility -Requirements and tests
IEC60601-2-2:1998 for Medical Electrical Equipment (Part2-2): Particular ● Requirements for the Safety of High Frequency Surgical Equipment.

As with the cleared Dyonics® ElectroBlade™ Resectors, these proposed devices have been demonstrated to be in compliance with the following standards:

ANSI/AAMI ISO 10993-1 for Biological evaluation of medical devices -. Part1: Guidance on selection of tests
ANSI/AAMI ISO 11135 Validation and Routine control of Ethylene Oxide Sterilization

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.

Public Health Service

JUN 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Provencher Regulatory Affairs Specialist Smith & Nephew. Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K031675

Trade/Device Name: Smith & Nephew Dyonics® ElectroBlade™ Resector Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 29, 2003 Received: May 30, 2003

Dear Ms Provencher:

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. Iisting 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 mav 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 (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. Karen Provencher

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) you may obtain. 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,

Muriam C. Provost

( Celia M. Witten, Ph.D., M.D. 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):	K031675
---------------------------	---------

Device Name: Smith & Nephew Dyonics® ElectroBlade™ Resector

Indications For Use:

The Smith & Nephew Dyonics® ElectroBlade™ Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The Smith & Nephew Dyonics® ElectroBlade™ Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.

Miriam C. Provost

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

510(k) Number K031675

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Smith+Nephew Dyonics® ElectroBlade ™ Resector Page 14 of 7.

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.