The ArthroCare Irrigation Pump is an accessory, supplied separately, that can be used with the following Electrosurgery Systems for the referenced indications:

The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and . coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.

Device Description

The Irrigation Pump is an accessory that may be used with ArthroCare's Electrosurgery Systems. The Irrigation Pump consists of the Irrigation Pump and Flow Control Cable. The ArthroCare Irrigation Pump is designed to automate the flow of conductive media during soft tissue ablation and coagulation where conductive media must be delivered to the treatment site.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ArthroCare Irrigation Pump. It states that the submission is a "Special 510(k)" proposing a "modification in the performance specifications, ergonomic user interface, and labeling for the ArthroCare Flow Control Unit." It also explicitly mentions that "The indications for use and principal of operation remain the same as in the originally cleared 510(k)."

Given this information, the study described is a performance modification study rather than a de novo effectiveness study for a new device. Therefore, the focus is on demonstrating that the modified device's performance is equivalent to the predicate device, not necessarily on meeting specific clinical acceptance criteria or conducting extensive clinical trials as would be required for a new therapeutic or diagnostic device.

Based on the provided text, there is no information about acceptance criteria or a study that typically measures a device's performance against such criteria using patient data, ground truth, expert opinions, or statistical metrics like sensitivity, specificity, or MRMC studies. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on modifications to performance specifications, user interface, and labeling, rather than presenting a detailed clinical or diagnostic performance study.

Therefore, most of the requested information cannot be extracted from the provided document.

Here's a breakdown of what can and cannot be answered based on the input:

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

Cannot be provided. The document describes a Special 510(k) for modifications to an existing device, focusing on "performance specifications, ergonomic user interface, and labeling." It does not specify new quantitative acceptance criteria or report performance data against such criteria in the context of clinical outcomes or diagnostic accuracy. The "performance specifications" being modified would likely refer to engineering or functional specifications (e.g., flow rate, pressure, durability) rather than clinical performance metrics.

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

Cannot be provided. The document does not describe a clinical test set or data provenance.

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):

Cannot be provided. The concept of "ground truth" established by experts for a test set is not applicable to the information given, as no such clinical study is described.

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

Cannot be provided. No test set or adjudication method is mentioned.

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:

Cannot be provided. This is an irrigation pump, not a diagnostic or AI-assisted device. Therefore, an MRMC study is not relevant, and no information on human reader improvement with or without AI is present.

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

Cannot be provided. This is an irrigation pump and does not involve algorithms or AI for standalone performance.

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

Cannot be provided. No clinical ground truth is described.

8. The sample size for the training set:

Cannot be provided. This device does not involve a training set as would be used for AI or machine learning.

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

Cannot be provided. Not applicable.

Summary of available information:

Device: ArthroCare Irrigation Pump
Type of Submission: Special 510(k)
Purpose of Submission: Modification in "performance specifications, ergonomic user interface, and labeling" for the ArthroCare Flow Control Unit (predicate K001904).
Key Statement: "The indications for use and principal of operation remain the same as in the originally cleared 510(k)."

This document primarily serves to demonstrate that the modified device remains "substantially equivalent" to its predicate, rather than detailing a study against specific clinical performance acceptance criteria.

Summary

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MAR 2 0 2008

2482 510(k) Summary

ArtroCare Corporation ArthroCare Irrigation Pump

Page 1 of ②

Manufacturer:	ArthroCare Corporation
	680 Vaqueros Avenue
	Sunnyvale, CA 94085-2936
Establishment Registration Number:	2951580
Contact Person:	Valerie Defiesta-Ng
	Director, Regulatory Affairs
Date Prepared:	February 21, 2008
Device DescriptionClassification Name:	Electrosurgical Cutting and CoagulationDevice and Accessories(21 CFR 878.4400)
Trade Name:	ArthroCare Irrigation Pump
Generic/Common Name:	Electrosurgical Device and Accessories

Predicate Devices

· ArthroCare Flow Control Unit	K001904; cleared July 17, 2000
--------------------------------	--------------------------------

Intended Use

The ArthroCare Irrigation Pump is an accessory, supplied separately, that can be used with the following Electrosurgery Systems for the referenced indications:

The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and . coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, • and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.

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K080482

Product Description

Page 2 of ②

Substantial Equivalence

This Special 510(k) proposes a modification in the preformance specifications, ergonomic user interface, and labeling for the ArthroCare Flow Control Unit which was previoulsy cleared under K001904 on July 17, 2000. The indications for use and principal of operation remain the same as in the originally cleared 510(k).

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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 & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of curved lines and shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2008

ArthroCare Corporation % Ms. Valerie DeFiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523

Re: K080482

Trade/Device Name: ArthroCare Irrigation Pump Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, GXI Dated: February 21, 2008 Received: February 22, 2008

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 (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. Valerie DeFiesta-Ng

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.

Mark M. Millman

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 Statement

Device Name: ArthroCare Irrigation Pump

K_080482 510(k) Number:

Indications for use:

The ArthroCare Irrigation Pump is an accessory, supplied separately, that can be used with the following Electrosurgery Systems for the referenced indications:

The ArthroCare ENT Coblator Surgery System is indicated for ablation, resection, and . coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

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

Imita

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number

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.