ParComPlast™ is a solid block of polyurethane and fillers. It is intended to be used as material for construction of beam intensity modifiers for radiation therapy treatment. In use, a block of ParComPlast™ is placed into the holder of a milling machine such as described in our 510(k) K#883317, or, in similar machines produced by other manufacturers: a beam modifying filter is milled out using the x, y, z data supplied by either the planning computer or our contouring system. Once the filter is machined, it is mounted to the shadow tray plate using screws or double face tape and the plate is inserted into the holder on the accelerator for the patient's treatment.

AI/ML Overview

The provided document is a 510(k) summary for the ParComPlast™ Compensating Filter for Radiation Therapy. This device is a material used for constructing beam intensity modifiers in radiation therapy.

This document describes non-clinical testing for material substantial equivalence, not a study of device performance against acceptance criteria in the typical sense of diagnostic or AI-driven medical devices.

Therefore, most of the requested information (such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this type of submission. This device is a component material, and its evaluation focuses on material properties rather than diagnostic accuracy or clinical outcomes.

However, I can extract the relevant information from the document as it pertains to the material's equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material performance for use as a compensator in radiation therapy, comparable to aluminum.	"ParComPlast™ can be used as compensator material on a similar level as aluminum (is used clinically)."
No difference in material behavior compared to materials used in predicate devices.	"There is no difference in material behavior as materials used in the predicate devices."
No new questions of safety or effectiveness raised by technological characteristics.	Non-clinical testing demonstrates "no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness."

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

Sample Size for Test Set: Not specified in terms of clinical cases or patient data, as this was a non-clinical material test.
Data Provenance: Not applicable for this type of material evaluation. The testing was non-clinical.

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

Number of Experts: Not applicable. Ground truth was established through non-clinical material testing, not expert consensus on patient data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as this was a non-clinical material test, not an evaluation requiring human adjudication of clinical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC study was not done. This device is a material for radiation therapy equipment, not a diagnostic or AI-powered system where human reader performance would be a factor.

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

Standalone Performance Study: No, a standalone performance study was not done. This device is a physical material, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth was based on the performance and behavior of existing, clinically used materials (e.g., aluminum) for compensators in radiation therapy. This was established through non-clinical product testing to demonstrate material equivalence.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Ground Truth for Training Set: Not applicable, as this device does not use a training set.

Summary

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DEC 2 7 2002

- EXHIBIT 1

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: (0 2 (497

Submitter's Identification: 1.

S&S Par Scientific 10625 Telge Road Houston, Texas 77095

Date Summary Prepared: June 14, 2002

Contact: Mr. Fred Sopenoff Manager, Radiology Division

2. Name of the Device:

ParComPlast™ Compensating Filter for Radiation Therapy

3. Predicate Device Information:

1. K#000137, Enhanced Compensating Filter, Computerized Medical Systems, Inc., St. Louis, MO
1. K#010172. Lead Blocks, Arplay Medical S.A., Cote D'or, France

4. Device Description:

5. Intended Use:

To shape the beam for a radiation therapy source.

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6. Comparison to Predicate Devices:

1. K#000137. Enhanced Compensating Filter, Computerized Medical Systems, Inc., St. Louis, MO, which is compensator milled directly from aluminum or brass block, and
1. K#010172, Lead Blocks, Arplay Medical S.A., Cote D'or, France, which are lead blocks of varying sizes and heights to build compensator filters.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Product testing contained in this 510(k) submission demonstrated that ParComPlast™ can be used as compensator material on a similar level as aluminum (is used clinically). There is no difference in material behavior as materials used in the predicate devices.

8. Discussion of Clinical Tests Performed:

Not Applicable

ல் Conclusions:

The subject device, ParComPlast™ Compensating Filter for Radiation Therapy has the same intended use and similar characteristics as the predicate devices. Non-clinical testing supplied in our 510(k) submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness. Thus, ParComPlast™ is substantially equivalent to the predicate devices.

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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 with three curved lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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DEC 27. 2002

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850.

S & S Par Scientific % Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021

Re: K021987 Trade/Device Name: ParComPlast™ Cornpensating Filter for Radiation Therapy Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: 90 IXI Dated: October 8, 2002 Received: October 10, 2002

Dear Ms. Goldstein-Falk:

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 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 applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
. 892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Nancy C. Snogdin

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit B

Page 1 of 1

510(k) Number (if known): K021987

Device Name: ParComPlast™ Compensating Filter for Radiation Therapy Indications For Use:

To shape the beam from a radiation therapy source.

(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)

Over-The-Counter Use (Optional Format 1-2-96)

Hansil Huston

021987 510(k) Nu

Regulation Number and Section

§ 892.5710 Radiation therapy beam-shaping block.

(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.