Parallax® Acrylic Resin Cartridge with TRACERS is intended for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Description

Parallax® Acrylic Resin Cartridge with TRACERS is an opacified polymethylmethacrylate bone cement.

AI/ML Overview

This document is a 510(k) summary for a medical device (Parallax® Acrylic Resin Cartridge with TRACERS) and an FDA clearance letter. It is for a bone cement and describes its intended use and substantial equivalence to a predicate device.

It does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance characteristics (like strength, setting time, etc.). The document is focused on regulatory clearance based on substantial equivalence.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
Standalone performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This information would typically be found in a more detailed technical report or study protocol, which is not provided in the given text. The 510(k) process often relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive de novo studies against specific performance criteria for every new submission, especially for material modifications.

Summary

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JAN 2 5 2006

Parallax® Acrylic Resin Cartridge with TRACERS

510(k) Summary ArthroCare Corporation

General Information
Manufacturer:	ArthroCare, Corporation680 Vaqueros AvenueSunnyvale, CA 94085
Establishment Registration Number:	2951580
Contact Person:	Valerie Defiesta-NgDirector, Regulatory Affairs
Date Prepared:	November 11, 2005
Device Description
Classification:	PMMA Bone Cement: Class II per 21 CFR888.3027
Trade Name:	Parallax ® Acrylic Resin Cartridge With TRACERS
Device Code:	NDN
Generic/Common Name:	Bone Cement
Predicate Device
Parallax ® Acrylic Resin with TRACERS ® :	K042947

Intended Use

Product Description

Parallax® Acrylic Resin Cartridge with TRACERS is an opacified polymethylmethacrylate bone cement.

Substantial Equivalence

The subject device is substantially equivalent to the ArthroCare Parallax Acrylic Resin with TRACERS (K042947).

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Image /page/0/Picture/14 description: The image shows the logo for ArthroCare Corporation. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is made up of several curved lines that resemble a wave or a stylized sun. The text "ArthroCare" is in a bold, sans-serif font, and below it is the word "Corporation" in a smaller, lighter font.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines forming the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2006

Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthoCare Corp. 680 Vaqueros Ave. Sunnyvale, California 95408

Re: K053180

Trade/Device Name: Parallax Acrylic Resin Cartridge with Tracers Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: November 11, 2005 Received: November 14, 2005

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

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Page 2 - Ms. Valerie Defiesta-Ng

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 (240) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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 Statement

510(k) Number (if known):

KOS 3180

Device Name:

Parallax® Acrylic Resin Cartridge with TRACERS

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) X

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

(Division Sign-Off) (Division Sign of General, Restorative, Division rological Devices

510(k) Number_KOS3180

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”