TRACERS® Ta Bone Cement Opacifier is an additive to be used with Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of the implant material. The TRACERS® Ta Bone Cement Opacifier is added to the Secour polymer (powder) prior to mixing with the Secour monomer (liquid). TRACERS Bone Cement Opacifier is comprised of USP Barium Sulfate and unalloyed Tantalum disks.

AI/ML Overview

The provided text describes a 510(k) summary for the TRACERS® Ta Bone Cement Opacifier, focusing on its substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, many of the requested details are not available in the given document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on specific performance acceptance criteria for a new clinical or technical study.

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

This information is not available. The document does not describe a performance study with a test set.

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

This information is not available. The document does not describe a performance study that involved expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not available. The document does not describe a performance study involving adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned. The device's purpose is as an additive to provide radiopacity, not typically requiring this type of study for a 510(k) submission of this nature.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the described device. The TRACERS® Ta Bone Cement Opacifier is a physical additive to a medical cement to enhance radiopacity for imaging purposes. It is not an algorithm or a software-based device that would have standalone performance (algorithm only) testing.

7. The Type of Ground Truth Used

This information is not available. The 510(k) submission is based on substantial equivalence, not on the performance against a defined ground truth from a study. The "ground truth" for this device would inherently be its physical properties and chemical composition, which are confirmed through validation of its manufacturing and material specifications, and its ability to become radiopaque as intended. The document states its intended use is "to provide radiopacity for imaging purposes," which implies that its performance would be assessed by its visibility under imaging. However, a specific study establishing "ground truth" in the context of clinical outcomes or expert consensus is not described.

8. The Sample Size for the Training Set

This information is not applicable and not available. The TRACERS® Ta Bone Cement Opacifier is a medical device (an additive), not a machine learning or artificial intelligence system that would require a training set.

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

This information is not applicable and not available, as there is no training set for this type of device.

Summary of the Document's Content:

The K033230 submission for TRACERS® Ta Bone Cement Opacifier is a 510(k) premarket notification. Its primary argument for market clearance is substantial equivalence to an already legally marketed predicate device, TRACERS® Bone Cement Opacifier (K023445).

Intended Use: To be used as an additive to Secour Acrylic Resin to provide radiopacity for imaging purposes.
Product Description: Comprised of USP Barium Sulfate and unalloyed Tantalum disks, mixed with the Secour polymer (powder) before liquid monomer is added.
The document explicitly states: "Based on the information provided in this notification, the subject device is substantially equivalent to the currently marketed predicate device with regard to intended use, technological characteristics, and design."

The FDA's response letter (DEC 12 2003) confirms a finding of substantial equivalence, allowing the device to be marketed. This type of submission does not typically involve extensive clinical performance studies with acceptance criteria, ground truth establishment, or human reader effectiveness studies as would be required for novel, higher-risk devices or AI/software-as-a-medical-device products. Instead, the focus is on demonstrating that the new device is as safe and effective as the predicate device based on its materials, design, and intended use.

Summary

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K033230

IV. 510(k) Summary

This summary of safety and effectiveness is being submitted in accordance with This Sammary of Salesy and Medical Devices Act of 1990 and 21 CFR §807.92.

Date Prepared A.

October 3, 2003

General Information B.

Manufacturer:	Parallax Medical, Inc.940 Disc DriveScotts Valley, CA 95066-4544
Contact:	Linda PaulManager, Regulatory and Clinical

ager, Regulatory and Clinical Affairs (831) 439-0130, ext 251 (phone) (831) 439-1725 (fax)

C. Device Information

Trade Name:	TRACERS® Ta Bone Cement Opacifier
Common Name:	Barium Sulfate with Tantalum
Device Classification:	II
Classification Name:	Accessory, Barium Sulfate, Methyl Methacrylate for Cranioplasty
Product Code(s):	MYU

Predicate Device Identification D.

The subject device is substantially equivalent to TRACERS® Bone Cement Opacifier (K023445).

Intended Use E.

TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour Acrylic Resin to provide radiopacity for imaging purposes.

F. Product Description

Substantial Equivalence G.

The subject device is equivalent in intended use, design, and technological characteristics to TRACERS® Bone Cement Opacifier (K023445).

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Summary H.

Based on the information provided in this notification, the subject device is Based on the information provided in the notinstilling with the nechnological characteristics, and design.

Signature of Preparer l.

The 510(k) summary was prepared and submitted by the following Parallax Medical employee.

Medical employee

Kolo Paul

Linda Paul Manager, Regulatory and Clinical Affairs

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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 stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

DEC 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Linda Paul Manager, Regulatory and Clinical Affairs Parallax Medical, Inc. 940 Disc Drive Scotts Valley, CA 95066

Re: K033230

Trade Name: TRACERS® Ta Bone Cement Opacifier Regulation Number: 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: Class II Product Code: MYU Dated: November 26, 2003 Received: November 28, 2003

Dear Ms. Paul:

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 (OS) regulation (21 CFR Part 820); and if

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Page 2 -- Ms. Linda Paul

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) rms reter 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), rr you deente specifical of Compliance at (301) 594-4639. 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 yours,

Mark N. Melleman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use lll.

Indications for Use

510(k) Number (if known): K033230

TRACERS® Ta Bone Cement Opacifier Device Name:

Indications for Use:

TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin to provide radiopacity for imaging purposes.

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

Prescription Use
✓
OR
Over-The Counter Use __
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

Post Restorative
K033230

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).