Parallax™ Tracer Radiopaque Particles are intended for use as an additive to Codman Cranioplastic™ (Type 1 - Slow Set) to provide radiopacity for imaging purposes.

Device Description

Parallax™ Tracer Radiopaque Particles

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Functional Characteristic)	Reported Device Performance
Substantially equivalent to Cranioplastic alone	Demonstrated to be substantially equivalent to Cranioplastic alone

2. Sample size used for the test set and data provenance

The provided text does not include information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The non-clinical test results section broadly states "Performance testing demonstrated...", without specific details on the test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The provided text does not include information regarding the number or qualifications of experts used to establish ground truth for a test set. This type of information is typically related to studies involving human interpretation or performance, which is not detailed here.

4. Adjudication method for the test set

The provided text does not include any information about an adjudication method for a test set.

5. 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text. The device is "Parallax™ Tracer Radiopaque Particles," an additive to a cranioplasty material, not an AI or diagnostic imaging device that would typically involve human reader performance studies in this context.

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

This question is not applicable. The device is a physical additive (radiopaque particles) to a cranioplastic material, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to performance studies of diagnostic algorithms is not directly applicable to this device. The "ground truth" in this context would likely refer to objective measurements of the functional characteristics of the combined material (Cranioplastic and Tracer Particles) compared to Cranioplastic alone. The text implies a comparison of "functional characteristics" to establish substantial equivalence.

8. The sample size for the training set

The provided text does not include information about a training set since this is not an AI or machine learning device.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for this device.

Summary

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Section 3 - 510(k) Summary

510(k) Number:

991993

Date Prepared: June 2, 1999

Applicant Information:

Applicant: Parallax Medical, Inc. 453 Ravendale Drive, Suite B Mountain View, CA 94043

Contact:	Susan G. Marques
	Manager, Regulatory Affairs

Phone:	(650) 934-6969
Fax:	(650) 934-6965

Device Information:

Parallax™ Tracer Radiopaque Particles Trade Name:

Barium Sulfate Common Name:

Equivalent Devices:

The subject device is substantially equivalent to Codman Cranioplastic™, Acrylic Cranioplasty Material (K8736989).

Intended Use:

Parallax™ Tracer Radiopaque Particles are intended for use as an additive to Codman Cranioplastic™ (Type 1 - Slow Set) to provide radiopacity for imaging purposes.

Comparison to Predicate Devices:

This device has the same functional characteristics as the predicate device.

Non-clinical Test Results:

Performance testing demonstrated that the end product (Cranioplastic and Tracer Particles) is substantially equivalent to Cranioplastic alone, with regards to functional characteristics.

Summary:

Based on the product performance information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 1999

Ms. Susan G. Marques Manager, Regulatory Affairs Parallax Medical, Inc. 453 Ravendale Drive, Suite B Mountain View, California 94043

Re: K991893

Trade Name: Parallax Tracer Radiopaque Particles Regulatory Class: II Product Code: MYU Dated: July 16, 1999 Received: July 19, 1999

Dear Ms. Marques:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 – Ms. Susan G. Marques

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

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Section 4 - Statement of Indications for Use

Indications for Use

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510(k) Number (if known): K 99189 3

Device Name: Parallax™ Tracer Radiopaque Particles

Indications for Use:

・

Parallax™ Tracer Radiopaque Particles are intended for use as an additive to Codman Cranioplastic™ (Type 1 - Slow Set) to provide radiopacity for imaging purposes.

(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 General Restorative Devices
510(k) Number	K991893
Prescription Use	OR	Over-The Counter Use
(Per 21 CFR 801.109) X		(Optional Format 1-2-96)

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).