The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Arthroscopic and Orthopedic Procedures	Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist)
Ablation and Debridement
• ACL/PCL	Knee
• Acromioplasty	Shoulder
• Articular Cartilage	All Joints
• Bursectomy	All Joints
• Chondroplasty	All Joints
• Facia	All Joints
• Ligament	All Joints
• Notchplasty	Knee
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Subacromial Decompression	Shoulder
• Synovectomy	All Joints
• Tendon	All Joints
Excision and Resection
• Acetabular Labrum	Hip
• Articular Labrum	All Joints
• Capsule	All Joints
• Capsular Release	Knee
• Cartilage Flaps	Knee
• Cysts	All Joints
• Discoid Meniscus	Knee
• Frozen Shoulder Release	Shoulder
• Glenoidale Labrum	Shoulder
• Lateral Release	Knee
• Ligament	All Joints
• Loose Bodies	All Joints
• Meniscal Cystectomy	Knee
• Meniscectomy	Knee
• Plica Removal	All Joints
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Synovial Membrane	All Joints
• Tendon	All Joints
• Triangular Fibrocartilage (TFCC)	Wrist
• Villusectomy	Knee
Coagulation
• ACL/PCL	Knee
• Articular Cartilage	All Joints
• Carpal Ligaments	Wrist
• Glenohumeral Capsule	Shoulder
• Ligament	All Joints
• Medial Retinaculum	Knee
• Rotator Cuff	Shoulder
• Tendon	All Joints
• Wrist Tendons	Wrist

Device Description

The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

AI/ML Overview

The provided document, K030551, is a 510(k) Pre-market Notification for the ArthroCare ArthroWands. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies with reported performance metrics.

Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics for the device itself (as if it were a novel device undergoing clinical efficacy trials) is not present in this document. The document primarily attests that the modifications to the ArthroWands do not significantly affect safety or efficacy compared to the previously cleared predicate device (K020557).

Here's an breakdown based on the available information:

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

This document does not contain a table of acceptance criteria or reported device performance in the way one would expect for a de novo submission or a clinical trial report. The "acceptance criteria" here is implicitly "substantial equivalence" to the predicate device. The performance is assessed through the unchanged indications for use and principle of operation.

Acceptance Criteria	Reported Device Performance
Maintain safety and effectiveness as predicate device (K020557)	"The proposed modification in dimensional specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." (page 2)
Indications for Use remain identical to predicate device	The stated "Indications for Use" for the modified ArthroWands are identical to those of the predicate device (pages 1-2 and 5-6).
Technology and Principle of Operation remain identical to predicate device	"The indications for use, technology, principle of operation, performance specifications, materials, and sterilization parameters of the ArthroWands remain the same as in the predicate cleared 510(k)." (page 2)

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. As a 510(k) for modifications to a predicate device, it likely relies on non-clinical testing (e.g., bench testing for dimensional changes, material compatibility) and a comparison to the established safety and efficacy of the predicate device, rather than a clinical "test set" in the traditional sense.

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 document does not describe a clinical study requiring ground truth established by experts.

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

This information is not applicable/not provided. There is no description of a clinical test set requiring adjudication.

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

This information is not applicable/not provided. This device is an electrosurgical tool, not an AI-powered diagnostic imaging device.

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

This information is not applicable/not provided. This is an electrosurgical device, not an algorithm.

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

This information is not applicable/not provided. The assessment relies on substantial equivalence to the predicate device, which would have had its own methods of demonstrating safety and effectiveness originally (likely through a combination of non-clinical and potentially some clinical data, but not detailed here).

8. The sample size for the training set

This information is not applicable/not provided. This document does not describe a machine learning algorithm requiring a training set.

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

This information is not applicable/not provided. No training set is mentioned as this device is not an AI/ML product.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for ArthroCare Corporation. Below the logo is the text "K030551" and a horizontal line. Under the line is the text "510(k) Summary".

MAR 0 7 2003

ArthroCare Corporation ArthroCare ArthroWands

General Information
Submitter Name/Address:	ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-2936
Establishment Registration Number:	2951580
Contact Person:	Valerie Defiesta-NgDirector, Regulatory Affairs
Date Prepared:	February 20, 2003
Device Description
Trade Name:	ArthroCare® ArthroWands®
Generic/Common Name:	Electrosurgical Device and Accessories
Classification Name:	Electrosurgical Cutting and CoagulationDevice and Accessories (21 CFR878.4400)
Predicate DevicesArthroCare ArthroWands	K020557

Product Description

The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

{1}------------------------------------------------

Intended Use

The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Arthroscopic and Orthopedic Procedures	Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist)
Ablation and Debridement
• ACL/PCL	Knee
• Acromioplasty	Shoulder
• Articular Cartilage	All Joints
• Bursectomy	All Joints
• Chondroplasty	All Joints
• Facia	All Joints
• Ligament	All Joints
• Notchplasty	Knee
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Subacromial Decompression	Shoulder
• Synovectomy	All Joints
• Tendon	All Joints
Excision and Resection
• Acetabular Labrum	Hip
• Articular Labrum	All Joints
• Capsule	All Joints
• Capsular Release	Knee
• Cartilage Flaps	Knee
• Cysts	All Joints
• Discoid Meniscus	Knee
• Frozen Shoulder Release	Shoulder
• Glenoidale Labrum	Shoulder
• Lateral Release	Knee
• Ligament	All Joints
• Loose Bodies	All Joints
• Meniscal Cystectomy	Knee
• Meniscectomy	Knee
• Plica Removal	All Joints
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Synovial Membrane	All Joints
• Tendon	All Joints
• Triangular Fibrocartilage (TFCC)	Wrist
• Villusectomy	Knee
	Arthroscopic and Orthopedic Procedures	Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist)
Coagulation
•	ACL/PCL	Knee
•	Articular Cartilage	All Joints
•	Carpal Ligaments	Wrist
•	Glenohumeral Capsule	Shoulder
•	Ligament	All Joints
•	Medial Retinaculum	Knee
•	Rotator Cuff	Shoulder
•	Tendon	All Joints
•	Wrist Tendons	Wrist

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

Continued

Substantial Equivalence

This Special 510(k) proposes modifications in dimensional specifications, materials, and labeling for the ArthroCare ArthroWands, which were previously cleared under K020557 on March 21, 2002. The indications for use, technology, principle of operation, performance specifications, materials, and sterilization parameters of the ArthroWands remain the same as in the predicate cleared 510(k).

Summary of Safety and Effectiveness

The modified ArthroWands, as described in this submission, are substantially equivalent to the predicate ArthroWands. The proposed modification in dimensional specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ArthroCare Corporation Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-2936

MAR 0 7 2003

Re: K030551

Trade/Device Name: ArthroCare® ArthroWands® Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 20, 2003 Received: February 21, 2003

Dear Ms. Defiesta-Ng:

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

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Page 2 – Ms. Valerie Defiesta-Ng

(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. 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). 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

Col 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 Statement

Device Name: ArthroCare ArthroWands

510(k) Number: K_030551

Indications for use:

The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Arthroscopic and Orthopedic Procedures	Joint Specific or AllJoints (ankle, elbow,hip, knee, shoulder, andwrist)
Ablation and Debridement
• ACL/PCL	Knee
• Acromioplasty	Shoulder
• Articular Cartilage	All Joints
• Bursectomy	All Joints
• Chondroplasty	All Joints
• Facia	All Joints
• Ligament	All Joints
• Notchplasty	Knee
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Subacromial Decompression	Shoulder
• Synovectomy	All Joints
• Tendon	All Joints
Excision and Resection
• Acetabular Labrum	Hip
• Articular Labrum	All Joints
• Capsule	All Joints
• Capsular Release	Knee
• Cartilage Flaps	Knee
• Cysts	All Joints
• Discoid Meniscus	Knee
• Frozen Shoulder Release	Shoulder
• Glenoidale Labrum	Shoulder
• Lateral Release	Knee
• Ligament	All Joints
• Loose Bodies	All Joints
• Meniscal Cystectomy	Knee
• Meniscectomy	Knee

{6}------------------------------------------------

Continued

Arthroscopic and Orthopedic Procedures	Joint Specific or AllJoints (ankle, elbow,hip, knee, shoulder, andwrist)
• Plica Removal	All Joints
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Synovial Membrane	All Joints
• Tendon	All Joints
• Triangular Fibrocartilage (TFCC)	Wrist
• Villusectomy	Knee
Coagulation
• ACL/PCL	Knee
• Articular Cartilage	All Joints
• Carpal Ligaments	Wrist
• Glenohumeral Capsule	Shoulder
• Ligament	All Joints
• Medial Retinaculum	Knee
• Rotator Cuff	Shoulder
• Tendon	All Joints
• Wrist Tendons	Wrist

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

(Per 21 CFR
801.109)

iriam C. Provost

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

510(k) Number K630551

İX

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.