Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta 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® EZFlow™ Cement Delivery System is a delivery system for the Parallax Acrylic Resin with TRACERS and Parallax Acrylic Resin with TRACERS Ta. It is designed to provide surgeons with a means to inject Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACERS Ta for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. The EZFlow Cement Delivery System does not contain any bone cement material, as this system only consists of general instruments. All of the system components are manual, single-use disposable instruments.

AI/ML Overview

The provided text is a 510(k) summary for the ArthroCare Corporation Parallax® EZFlow™ Cement Delivery System. This document does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically associated with AI/software devices (e.g., performance metrics, clinical trials).

Instead, this is a regulatory submission for a medical device that is a cement dispenser, which is a physical instrument, not a software or AI tool. The "study" mentioned here refers to the process of demonstrating "substantial equivalence" to a predicate device for regulatory clearance, not a performance study against specific acceptance criteria with quantifiable metrics like sensitivity, specificity, etc.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not applicable to this type of device and submission.

Here's a breakdown based on the information provided and what can be inferred about this type of device:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy). For a physical medical device like a cement dispenser, acceptance criteria would typically involve engineering specifications, material compatibility, functional reliability (e.g., consistent flow rate, resistance to leakage, ease of use), and biocompatibility. These are usually established internally by the manufacturer and evaluated during product development and verification testing.
- Reported Device Performance: The document states that "ArthroCare evaluated the indications for use, functional testing, and prospective clinical data to demonstrate equivalence to the predicate devices." This implies that the device performed adequately in these tests to demonstrate equivalence, but no specific performance statistics are provided.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. The "test set" here would refer to the physical devices undergoing functional testing or perhaps patients in a clinical study if one was performed to demonstrate equivalence. The document mentions "prospective clinical data," but gives no details on the sample size or provenance.
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):
- Not applicable/Not provided. For a physical device like this, "ground truth" establishment in the context of expert review (e.g., for image interpretation) is not relevant. If "clinical data" was used, the "ground truth" would likely be patient outcomes or physician assessments related to the procedure's success or safety.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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:
- Not applicable. This is for a physical medical device, not an AI/software product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for a physical medical device, not an AI/software product.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Based on "prospective clinical data," the ground truth likely involved outcomes data and/or physician assessments related to the successful fixation of fractures, absence of complications, and overall safety and efficacy in the context of vertebroplasty or kyphoplasty procedures.
The sample size for the training set:
- Not applicable for a physical device. "Training set" refers to data used to train AI models.
How the ground truth for the training set was established:
- Not applicable for a physical device.

Summary specific to this device:

The "study" that proves this device meets its requirements is the demonstration of substantial equivalence to existing predicate devices (specifically, the Parallax® Cement Injector Kit, K980064 and another unspecified "currently marketed device"). This involves:

Indications for Use: Showing that the device serves the same purpose as the predicate.
Functional Testing: Demonstrating that the device performs its intended mechanical functions (e.g., cement delivery) reliably and safely, similar to the predicate.
Prospective Clinical Data: Potentially gathering data from actual use to confirm safety and performance outcomes, and similarity to the predicate device in a clinical setting.

The 510(k) clearance process focuses on whether the new device is "as safe and effective" as a legally marketed device, not on proving absolute efficacy against specific, quantifiable performance metrics in a de novo trial. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence is the "proof" that the device met the regulatory requirements for market clearance as described in this document.

Summary

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510(k) Summary of Safety and Effectiveness ArthroCare Corporation Parallax® EZFlow™ Cement Delivery System

General Information

Manufacturer:	ArthroCare, Corporation680 Vaqueros AvenueSunnyvale, CA 94085
Establishment Registration Number:	2951580
Contact Person:	Valerie Defiesta-NgDirector, Regulatory Affairs
Date Prepared:	July 1, 2005

Device Description

Classification:	Cement Dispenser: Class I Exempt per 21 CFR 888.4200
Trade Name:	Parallax ® EZFlow ™ Cement Delivery System
Device Code:	OAR and KIH
Generic/Common Name:	Cement Dispenser

Predicate Devices

Parallax® Cement Injector Kit

K980064

Intended Use

Parallax® EZFlow™ Cement Delivery System is intended for use with Parallax Acrylic Resin with TRACERS or Parallax Acrylic Resin with TRACER Ta 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).

Product Description

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Substantial Equivalence

In establishing substantial equivalence, ArthroCare evaluated the indications for use, functional testing, and prospective clinical data to demonstrate equivalence to the predicate devices. We believe the EZFlow Cement Delivery System is substantially equivalent to the currently marketed device in its intended use.

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.

JAN 3 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051820

Trade/Device Name: Parallax EXFlow Cement Delivery System Regulation Number: 21 CFR 888.4200 Regulation Name: Cement Dispenser Regulatory Class: Class I Exempt Product Code: OAR Dated: September 6, 2005 Received: September 6, 2005

Dear Ms. Defiesta-Ng:

This letter corrects our exempt letter of September 6, 2005.

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.

We note that your device exceeded the Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 CFR Part 888.9), and therefore required the submission and clearance of a premarket notification prior to commercial distribution in the United States. Future devices of this same type, that meet the exemption criteria and do not exceed the limitations of exemptions found in 21 CFR Part 888.9 will be exempt from the premarket notification requirements of the Act.

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

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Page 2 - Ms. Valerie DeFiesta-Ng

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 I loase be deviloed that I Dr brains that your device complies with other requirements of the Act that I Drimas intatutes 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. production 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 premaince holicated 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/dsma/dsmamain.html

Sincerely vours,

Barbara Brown

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 for Use

510(k) Number (if known): K051820

Device Name: Paralax® EXFlow™ Cement Delivery System

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 888.4200 Cement dispenser.

(a)
Identification. A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.