The ArthroCare® Parallax® Contour® Vertebral Augmentation Device 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 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 acceptance criteria and supporting studies for the ArthroCare® Parallax® Contour® Vertebral Augmentation Device, structured according to your request.

Please note: The provided text primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria in a quantitative, pass/fail manner. The "reported device performance" are observations and outcomes from the studies conducted to support this equivalence.

Acceptance Criteria and Study Findings for ArthroCare® Parallax® Contour® Vertebral Augmentation Device

The information provided within the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through functional performance testing, pre-clinical cadaveric studies, and a clinical study. The "acceptance criteria" are implied by the successful outcomes of these studies and the finding of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Implied)	Reported Device Performance
Functional Equivalence	Functional performance testing showed successful torque, insertion/withdrawal, flexure, device attachment/deployment/removal, and mechanical displacement of bone, demonstrating mechanical characteristics equivalent to the predicate.
Void Creation Volume (Pre-clinical)	In simulated human foam bone blocks, void volumes were similar between the Contour and predicate devices, with no statistically significant differences.
Cement Delivery Volume (Pre-clinical)	In cadaveric vertebral bodies, the Contour and predicate devices demonstrated equivalence in the volume of Parallax PMMA bone cement delivered.
Increased Cement Delivery vs. Standard Vertebroplasty (Pre-clinical)	Use of the Contour device prior to cement augmentation allowed significantly more cement delivery into the vertebral body compared to standard vertebroplasty procedure (control group where Contour was not used).
Clinical Void Volume	Range of void creation from 0.33 to 2.02 cc for individual patients.
Clinical PMMA Instillation Volume	Range of PMMA instillation from 2.9 to 8.5 cc.
Clinical Safety (Extravasation)	Four cases demonstrated imaging evidence of PMMA extravasation into paravertebral veins; all four cases were asymptomatic.
Clinical Effectiveness (Pain Reduction)	Mean VAS pain score was significantly reduced (dependent t-test, p<0.01), with a post-procedure mean score of 2.19 +/- 0.41 points.
Clinical Safety (Complications)	No patient complications were observed in all cases.

2. Sample Sizes and Data Provenance

Test Set (Pre-clinical Cadaveric):
- Sample Size: Not explicitly stated as a distinct "test set" size. The text mentions "cadaveric vertebral bodies" for the equivalence study and "human cadaver fractured vertebral discs" for the comparative study.
- Data Provenance: Human cadaveric material. Country of origin not specified, but typically conducted in the country of the research institution or manufacturer (implied US). Retrospective or prospective nature not specified for cadaveric studies, but generally considered pre-clinical, controlled experiments.
Test Set (Pre-clinical Foam Bone):
- Sample Size: Not explicitly stated, but implies a sufficient number of simulated human foam bone blocks were used for statistical comparison.
- Data Provenance: Simulated human foam bone blocks.
Test Set (Clinical Study):
- Sample Size: Number of patients not explicitly stated, but the results describe "individual patients" and "four cases" with extravasation. The statement "In all cases, no patient complications were observed" suggests the study tracked outcomes for all enrolled patients.
- Data Provenance: Clinical data from a "clinical study." Country of origin not specified, but implied to be
  a conventional clinical trial. Prospective, as it describes follow-up and outcomes.

3. Number of Experts and Qualifications for Ground Truth

Pre-clinical Studies (Cadaveric & Foam Bone): The text does not mention the use of experts to establish a "ground truth" in the way it's typically understood for diagnostic AI. The outcomes here were quantitative measurements (void volume, cement volume) based on the device's physical interaction with the materials and subsequent measurement.
Clinical Study: Not explicitly stated that experts established "ground truth" for the clinical outcomes (e.g., pain scores, extravasation, complications). These are direct patient outcomes or imaging observations. Clinical trials are typically evaluated by the treating physicians and study investigators, whose qualifications would be relevant clinicians (e.g., orthopedic surgeons, interventional radiologists).

4. Adjudication Method

Not applicable based on the provided text, as the studies described involve direct measurement of physical parameters and clinical outcomes rather than subjective interpretations requiring adjudication (e.g., diagnostic image interpretation).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The studies are focused on the device's physical performance, its ability to create a void, deliver cement, and its clinical safety and effectiveness in reducing pain. This is not a diagnostic device where human readers are interpreting images.

6. Standalone (Algorithm Only) Performance

No, this pertains to a physical medical device, not an algorithm, so a "standalone algorithm only" performance study is not applicable.

7. Type of Ground Truth Used

Pre-clinical Studies: Quantitative measurements (e.g., volume of void created, volume of cement delivered) from cadaveric specimens and foam bone models.
Clinical Study:
- Patient Outcomes: Measured VAS pain scores, observation of complications, and imaging evidence (e.g., for PMMA extravasation). This combines objective and subjective patient-reported outcomes.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

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

Summary

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K100479

510(k) Summary

2951580

SEP 2 1 2010

ArthroCare® Corporation Parallax® Contour® Vertebral Augmentation Device

General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

Director, Regulatory Affairs

Valerie Defiesta-Ng

408.736.0224

February 17, 2010

Establishment Registration Number:

Contact Person:

Contact Phone Number:

Date Prepared:

Device Description

Trade Name:

Classification Name:

Parallax® Contour® Vertebral Augmentation Device

Class II Polymethylmethacrylate (PMMA) bone cement (Section 888.3027) Pro-codes NDN:

Class 1 Cement dispenser (Section 888.4200) Pro-codes OAR; and

Class I Orthopedic Manual Surgical Instrument (Section 888.4540) Pro-codes . HXG

Predicate Devices

Parallax Contour Osteotome Access Needle Kits A V A flex Vertebral Augmentation Needle Class 1 exempt Class I exempt K072133

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Product Description

Intended Uses

The Parallax Contour Vertebral Augmentation Device 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

In establishing substantial equivalence to the predicate device, ArthroCare compared the indications for use, performance specifications, and technology 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 of the device.

A pre-clinical cadaveric study was conducted to evaluate the size void created by the Contour and predicate devices, as well as the volume of Parallax PMMA bone cement delivered during vertebral augmentation. This study demonstrated equivalence in performance of the Contour and predicate devices when used in cadaveric vertebral bodies. In addition, studies were also conducted to characterize Parallax bone cement volume distributed in human cadaver fractured vertebral discs. The test group used the Contour device to create a void prior to vertebral augmentation with bone cement; in the control group the Contour device was not used prior to vertebral augmentation. Comparative data between test group and the control group is reported in terms of relative fill of cement volume per vertebral body volume. Results demonstrates the Contour may be use to successfully create a void in the vertebral body, and that use of Contour device prior to cement augmentation allows significantly more cement delivery into the vertebral body compared to the standard vertebroplasty procedure. Testing was also conducted to compare the performance of the Contour and predicate devices in terms of volume of void created in simulated human foam bone blocks. Based on the results of the study, the void volumes were all similar in size, and no statistically significant differences were noted between the two devices. The pre-clinical studies demonstrate the Contour device performs equivalent to the predicate device.

A clinical study was conducted to evaluate clinical efficacy of the Contour device used in conjunction with PMMA bone cement to fill voids that have been created during perculaneous vertebral augmentation. The outcome showed the volume of the void percularious vertebral body using the Contour ranged from 0.33 to 2.02 cc for individual patients; the volume of PMMA instillation ranged from 2.9 to 8.5 cc; four cases

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demonstrated imaging evidence of PMMA extravasation into the paravertebral veins, all four cases were asymptomatic; and after the mean follow-up period, the mean VAS pain score was significantly reduced (dependent t-test, p<0.01), where the post-procedure mean score was 2.19 +/- 0.41 points. In all cases, no patient complications were observed. The results of the study demonstrated percutaneous vertebral augmentation using the Contour device was safe and effective for treating symptomatic vertebral compression fractures.

The performance testing, device comparison, pre-clinical, and clinical studies demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective.

Summary of Safety and Effectiveness

The Parallax Contour Vertebral Augmentation Device, as described in this premarket notification 510(k), is substantially equivalent to the predicate device. The differences in performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the proposed device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

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

SEP 2 1 2010

Re: K100479

Trade/Device Name: ArthroCare® Parallax® Contour® Vertebral Augmentation Device Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, OAR, HXG Dated: August 18, 2010 Received: August 19, 2010

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Valerie Defiesta-Ng

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 fart 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/ResourcesforYou/Industry/default.htm.

https://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm

Sincerely yours,

Barbav. Buetmo

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

Device Name	ArthroCare® Parallax® Contour® Vertebral Augmentation Device
510(k) Number	K062439

רדרטשו א 510(k) Number:

Indications for Use:

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) OR

Over-the-Counter Use

Division Sign-Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100479

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.”