TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT by VARIAN MEDICAL SYSTEMS, INC.

The Trilogy Tx Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The 3rd Party Couch Top Support is designed to position and support patients for radiotherapy. The Varian Exact ® Couch is designed for use with non-Varian aftermarket table tops.

Device Description

The Trilogy Tx Delivery System is being modified to include 3rd Party Couch Top Support.

The Exact couch patient positioning and support within the Trilogy Tx cleared device is partially accomplished by the motorized control of longitudinal, lateral, vertical and angular positions. The Exact couch top, also known as the couch stretcher top or the treatment table top is fastened to the Exact couch and is the primary portion of the couch for positioning and support. An Exact couch interface specification is available to non-Varian aftermarket couch top manufacturers for use in designing couch tops that are used on the Exact couch instead of the Varian Exact couch top.

3rd Party Couch Top Support (also known as Aftermarket "non-Varian" Couch Top Attachment) enables third party couch tops to be installed upon the Exact Couch base, replacing the original Varian Exact Couch Top. The replacement is implemented following a published Interface Specification. Physical installation is completed and qualified by Varian representatives at customer locations. following proprietary internal procedures to ensure safety and effectiveness equivalent to that of the original Exact Couch Top.

AI/ML Overview

This 510(k) summary describes a modification to an existing device, the Varian Trilogy Tx Delivery System, to include support for 3rd Party Couch Top Support. As such, the submission focuses on demonstrating that the modified device, when used with third-party couch tops, maintains the safety and effectiveness of the original system. This means the acceptance criteria and the study design are primarily concerned with the physical and functional integrity of the couch top interface and overall system, rather than clinical performance metrics in terms of disease diagnosis or treatment efficacy.

Here's an analysis of the provided text in relation to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific pass/fail acceptance criteria or quantitative performance metrics in a direct table format for the 3rd Party Couch Top Support. Instead, the "performance" discussed is centered on demonstrating substantial equivalence to the predicate device and ensuring safety and effectiveness equivalent to that of the original Exact Couch Top.

However, by inferring from the description of the device and the nature of the modification, the implicit acceptance criteria would revolve around:

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred/Stated)
Functional Equivalence: 3rd party couch tops can be installed on the Exact Couch base and function correctly for patient positioning and support.	"The replacement is implemented following a published Interface Specification. Physical installation is completed and qualified by Varian representatives at customer locations." This implies successful installation and initial functionality.
Safety: The use of 3rd party couch tops does not introduce new safety hazards or compromise the safety of the Trilogy Tx system.	"following proprietary internal procedures to ensure safety and effectiveness equivalent to that of the original Exact Couch Top."
Effectiveness: Patient positioning and support capabilities with 3rd party couch tops are equivalent to the original Varian Exact Couch Top.	"following proprietary internal procedures to ensure safety and effectiveness equivalent to that of the original Exact Couch Top." The 510(k) cleared the device, indicating that this claim was accepted by the FDA.
Compatibility: The 3rd party couch tops adhere to the Varian Exact couch interface specification.	"An Exact couch interface specification is available to non-Varian aftermarket couch top manufacturers for use in designing couch tops..." and "The replacement is implemented following a published Interface Specification."

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

The document does not specify a sample size for a "test set" in the traditional sense of a clinical or image-based diagnostic study. This submission is for a mechanical/functional modification. The "testing" or "qualification" likely involved:

Physical evaluation and testing of various 3rd party couch tops to ensure they fit the interface specifications and could be securely installed.
Functional tests (e.g., movement, patient load testing) with these couch tops on the Trilogy Tx system.

The data provenance is not explicitly stated as retrospective or prospective, or country of origin for such mechanical testing. However, given it's a device modification and qualification by the manufacturer (Varian Medical Systems, Palo Alto, CA, USA), the "data" would be internal engineering and quality assurance test results, most likely conducted prospectively during the development and validation phase.

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

This type of information is not relevant or present in this 510(k) submission. "Ground truth" in this context would typically refer to clinical or diagnostic accuracy. For a couch top modification, the "ground truth" is simply whether the couch can be securely attached, properly positioned, and can support a patient without failure, which is determined by engineering specifications and safety standards, not expert clinical consensus on a disease. The "experts" involved would be Varian's internal engineers and quality assurance personnel rather than radiologists or medical specialists establishing "ground truth" for a medical condition.

4. Adjudication Method for the Test Set

Again, an "adjudication method" as typically described for clinical studies (e.g., 2+1, 3+1) is not applicable here. The "adjudication" for this type of device modification would involve engineering review, compliance checks against specifications, and safety assessments by Varian's internal teams and ultimately, the FDA's review for substantial equivalence.

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

No, an MRMC comparative effectiveness study was not done, nor would it be relevant for this device modification. This submission is about a mechanical couch top interface, not an AI diagnostic or therapeutic aid affecting human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance test was not done. This device is a component of a radiation therapy system, not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

As discussed, the concept of "ground truth" in the clinical sense (e.g., pathology, outcomes data) does not apply to this 510(k) submission. The "ground truth" is the engineering specification for the couch interface, successful physical integration, and the demonstrated ability to maintain safety and functional performance equivalent to the original device. These are verified through engineering tests and physical validation, not clinical outcomes or expert consensus on medical conditions.

8. The Sample Size for the Training Set

This submission does not involve a "training set" in the context of machine learning or AI models. This is a modification to a physical medical device.

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

Since there is no "training set," this question is not applicable.

Summary

{0}------------------------------------------------

510(k) Summary

062618

The information below is provided for the Trilogy Tx with 3th Party Couch Top, following the format of 21 CFR 807.92.

SEP 2 2 2006

1. Submitter: Varian Medical Systems 3100 Hansen Way, M/S e110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: 650/424.5731 Fax: 650/842.5040 E-mail: vy.tran@yarian.com

	2. Name of the Device:	Trilogy Tx with 3rd Party Couch Top Support
	Trade / Proprietary Name:	Trilogy Tx Delivery System
	Common or Usual Name:	Trilogy Tx
	Classification Name:	Medical Charged Particle Radiation Therapy System
		21 CFR §892.5050
		Class II
	Product Code:	90 IYE

1. Predicate Device to claim substantial equivalence: Varian Medical Systems' Trilogy Tx Radiotherapy Delivery System - K061140

Description of the Device: 4.

The Trilogy Tx Delivery System is being modified to include 3rd Party Couch Top Support.

1. Intended Use Statement
  The Trilogy Tx Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

{1}------------------------------------------------

$$
\mathbb{Q} \circ \mathbb{Q} \not\mathbb{Q}
$$

1. Indications for Use Statement
  The Trilogy Tx Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The 3rd Party Couch Top Support is designed to position and support patients for radiotherapy. The Varian Exact ® Couch is designed for use with non-Varian aftermarket table tops.

1. Substantial Equivalence
  The 3rd Party Couch Top submission illustrates substantial equivalence to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 2 2 2006

Mr. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems 3100 Hansen Way, M/S/ E-110 PALO ALTO CA 94304

Re: K062618

Trade/Device Name: Trilogy Tx with 3td Party Couch Top Support Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 31, 2006 Received: September 5, 2006

Dear Mr. Tran:

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.

1f 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center, with the word "Centennial" underneath. Three stars are arranged below the word "Centennial". The text "Protecting and Promoting Your Health" is written around the circle.

Promoting Public

{3}------------------------------------------------

Page 2 -

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 (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.

This letter will allow you to begin marketing your device as the win your Section 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:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology.	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

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

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a bold, sans-serif font, with a stylized "I" that has a dot above it. Below the word "VARIAN" are the words "medical systems" in a smaller, sans-serif font.

Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com

Indications for Use Statement

510(k) Number (if known):

Device Name:

K062618
TRilogy Tx w 3rd Party Couch Top Support

The Trilogy Tx Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The 3rd Party Couch Top Support is designed to position and support patients for radiotherapy. The Varian Exact ® Couch is designed for use with non-Varian aftermarket table tops.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR Over-the-counter
(Per 21 CFR § 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.