The ArthroCare® Parallax® Contour® Vertebral Augmentation Device – enhanced when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax® Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

Device Description

The ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced is used to disrupt cancellous bone and create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement) during kyphoplasty or vertebral augmentation procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced, focusing on the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on a Special 510(k) submission, which means the device is a modification of an already cleared predicate device (K100479). For such submissions, the primary focus is to demonstrate that the changes do not significantly affect safety or efficacy and that the modified device performs comparably to the predicate. Therefore, the "acceptance criteria" here are largely related to maintaining the performance and characteristics of the predicate device.

Acceptance Criteria (Inferred from 510(k) Scope)	Reported Device Performance
Mechanical Characteristics & Performance remain the same as the predicate device. Specifically, this includes:	Functional performance testing completed to demonstrate equivalence. This testing covered:
- Torque performance	- Torque
- Insertion and Withdrawal performance	- Insertion and Withdrawal
- Flexure performance	- Flexure
- Device Attachment/Deployment/Removal performance	- Device Attachment/Deployment/Removal
- Mechanical Displacement of Bone performance	- Mechanical Displacement of Bone
Indications for Use remain the same.	Indications for Use remain the same as the predicate device.
Technology remains the same.	Technology remains the same as the predicate device.
Principle of Operation remains the same.	Principle of Operation remains the same as the predicate device.
Sterilization method remains the same.	Sterilization method remains the same as the predicate device.
Modifications are not substantial and do not significantly affect safety or efficacy.	"The proposed modifications... are not substantial changes, and do not significantly affect the safety or efficacy of the device."

Note on "Acceptance Criteria": In a 510(k) for a modified device, the "acceptance criteria" are not typically expressed as specific quantitative thresholds like "90% sensitivity" or "tensile strength > X N." Instead, the key criterion is demonstrating substantial equivalence to the predicate device, primarily through comparative testing that shows the modified device performs similarly or meets the same functional requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for the functional performance testing (test set). It only states that "Functional performance testing of the device included torque, insertion and withdrawal, flexure, device attachment/deployment/ removal, and mechanical displacement of bone have been completed."

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. Given the nature of mechanical performance testing for a medical device submitted to the FDA in the US, it is highly likely that this testing was conducted in a controlled laboratory environment in the US (prospective testing for this submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this specific submission. The "ground truth" for mechanical functional testing is typically established by engineering standards, validated test methods, and direct measurement against known physical properties or the performance of the predicate device, not by expert medical opinion in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

This is not applicable to the type of testing described. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints where differing opinions need to be resolved. The testing mentioned (torque, insertion, etc.) is objective mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No, an MRMC comparative effectiveness study was not done for this submission. MRMC studies are typically used to evaluate the impact of a diagnostic device (often image-based) on reader performance. This device is a surgical tool, and its evaluation focuses on mechanical performance and safety, not on improving human reader interpretation.

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

Not applicable. This device is a manual surgical instrument, not an algorithm or an AI system. Therefore, standalone performance (in the context of AI) is not relevant.

7. The Type of Ground Truth Used

For the functional performance testing, the "ground truth" would be established by:

Engineering specifications and standards: The device must meet predefined mechanical strength, flexibility, and operational parameters.
Performance of the Predicate Device: The modified device's performance is compared directly to the known and cleared performance characteristics of its predicate. The goal is to demonstrate that the new device performs within the acceptable range or equivalently to the predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical tool and does not involve AI or machine learning algorithms that would require a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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510(k) Summary

K110183 FEB 1 6 2011

ArthroCare Corporation ArthroCare Parallax Contour Vertebral Augmentation Device – enhanced

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:	January 20, 2011
Device Description
Trade Name:	ArthroCare Parallax Contour VertebralAugmentation Device - enhanced
Generic/Common Name:	Polymethylmethacrylate (PMMA) BoneCement
Classification Name:	Class II; Polymethylmethacrylate (PMMA)bone cement (Section 888.3027);Class 1 Cement dispenser (Section888.4200); andClass I Orthopedic Manual Instrument(Section 878.4540)
Predicate Device:ArthroCare Parallax ContourVertebral Augmentation Device	K100479 (cleared September 21, 2010)

Product Description

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Intended Use

The ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

Substantial Equivalence

This Special 510(k) proposes modifications to the dimensional specifications, material, and labeling of the ArthroCare Parallax Contour Vertebral Augmentation Device. The indications for use, technology, principle of operation, and sterilization of the ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced remain the same as in the predicate device.

Summary of Safety and Effectiveness

In establishing substantial equivalence to the predicate device, ArthroCare compared the indications for use, materials, dimensional specifications, and performance of the subject device to the predicate device. Functional performance testing of the device included torque, insertion and withdrawal, flexure, device attachment/deployment/ removal, and mechanical displacement of bone have been completed to demonstrate the mechanical characteristics and performance remain the same as the predicate device. The proposed modifications to the ArthroCare Parallax Contour Vertebral Augmentation Device enhanced are not substantial changes, and do not significantly affect the safety or efficacy of the device.

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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 stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

FEB 1 6 201

Re: K110183

Trade/Device Name: ArthroCare® Parallax® Contour® Vertebral Augmentation Device enhanced Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, OAR, HXG Dated: January 20, 2011 Received: January 21, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Valerie Defiesta-Ng

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Aliz K. iuta
for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K_____________________________________________________________________________________________________________________________________________________________________________ 510(k) Number: ArthroCare® Parallax® Contour® Vertebral Augmentation Device Name: Device - enhanced

Indications for use:

Prescription Use(Part 21 CFR 801Subpart D)	X	AND/OR	Over-the-Counter Use(21 CFR 807 SubpartC)
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(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 of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110183

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.”