PT2 Varian Proton Therapy System, provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatmont is indicated.

Device Description

PT2 Varian Proton Therapy System is a proton radiation therapy system which delivers therapeutic radiation in accordance with a physician's prescription. The system consists of four major components, 1) Cyclotron required to generate the photon beam 2) Beam line - transports beam from the cyclotron to the required treatment room 3) Up to 4 radiation treatment rooms 4) Treatment Control room

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for the PT2 Varian Proton Therapy System. This document, like many 510(k) submissions for medical devices, particularly for well-established technologies, does not typically contain the detailed performance study information you are requesting for an AI/ML device.

Here's why the requested information cannot be fully provided from this specific document:

Type of Device: The PT2 Varian Proton Therapy System is a physical medical device (a proton radiation therapy system), not an AI/ML software device. For such devices, acceptance criteria and performance studies focus on mechanical accuracy, dose delivery precision, safety, and functional equivalence to a predicate device, rather than metrics like sensitivity, specificity, or reader studies common for AI/ML.
Nature of 510(k) Submissions: 510(k)s aim to demonstrate substantial equivalence to a legally marketed predicate device. While they include summaries of verification and validation, they often do not delve into the granular details of all tests conducted, particularly not in a format relevant to AI/ML performance evaluation.
Date of Submission: This document is from 2010, preceding the significant rise and regulatory guidance for AI/ML in medical devices.

Therefore, for your specific points:

A table of acceptance criteria and the reported device performance: This document states: "Results of verification and validation testing demonstrate that the PT2 Varian Proton Therapy System satisfies the intended use as described above." However, it does not provide a table with specific quantitative acceptance criteria (e.g., beam energy deviation tolerance, beam positioning accuracy tolerance) and their corresponding reported performance values. The "Technological Characteristics" table compares features with a predicate device, but these are not acceptance criteria in the sense of a performance study.
Sample size used for the test set and the data provenance: Not applicable. This is not a study involving patient data in the context of an AI/ML algorithm. Performance testing would have involved physical measurements and engineering validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical proton therapy system. Ground truth typically refers to clinical diagnosis or pathology in AI/ML image analysis. Here, ground truth would be established by physical measurement standards and engineering specifications.
Adjudication method for the test set: Not applicable for a physical proton therapy system.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a framework for evaluating AI/ML impact on human interpretation, which is not relevant for a proton therapy delivery system.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. Performance testing for this device would be its ability to deliver a proton beam according to specifications, not an algorithm's diagnostic output.
The type of ground truth used: For a physical device like this, ground truth would be against established physics principles, engineering specifications, and validated measurement techniques (e.g., dosimetry, beam profiling). The document does not specify these in detail beyond stating "verification and validation testing."
The sample size for the training set: Not applicable. This is not an AI/ML algorithm that is trained on data.
How the ground truth for the training set was established: Not applicable.

In summary, while the document confirms that verification and validation were performed and the device meets its intended use, it does not provide the detailed performance study information requested, as it is for a physical medical device and not an AI/ML product.

Summary

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

Premarket Notification [510(k)] Summary PT2 Varian Proton Therapy System

DEC 27 2010

The following information is provided following the format of 21 CFR 807.92.

Submitter's Name:	Varian Medical Systems, Inc.3100 Hansen Way e-110Palo Alto, CA 94304
	Contact Name: Vy TranPhone: 650/424.5731Fax: 650/842.5040Date: 5 May 2010
Proprietary Name:	PT2 Varian Proton Therapy System
Classification Name:	Medical charged-particle radiation therapy system21 CFR 892.5050, Class IIProduct Code: LHN
Common/Usual Name:	Proton Therapy System
Predicate Devices:	Proteus 235 Proton Therapy System from Ion Beam Applications S.A.(K082416).
Device Description:	PT2 Varian Proton Therapy System is a proton radiation therapy systemwhich delivers therapeutic radiation in accordance with a physician'sprescription.
	The system consists of four major components,
	1) Cyclotron required to generate the photon beam2) Beam line - transports beam from the cyclotron to the requiredtreatment room3) Up to 4 radiation treatment rooms4) Treatment Control room
Statement of Intended Use	PT2 Varian Proton Therapy System provides protons for precisionradiotherapy of lesions, tumors, and conditions anywhere in thebody where radiation treatment is indicated.
Statement of Indications for Use:	PT2 Varian Proton Therapy System provides protons for precisionradiotherapy of lesions, tumors, and conditions anywhere in thebody where radiation treatment is indicated.
Technological Characteristics:	See device comparison table below.
Description	IBA Proton Therapy System - Proteus 235	PT2 Varian Proton Therapy System
510(k) Number	K082416	K101294
Intended Use	The PTS is a medical device designed toproduce and deliver a proton beam for thetreatment of patients with localized tumorsand other conditions susceptible totreatment by radiation.	PT2 Varian Proton Therapy System providesprotons for precision radiotherapy oflesions, tumors, and conditions anywhere inthe body where radiation treatment isindicated.
Indications For Use	The PTS is a medical device designed toproduce and deliver a proton beam for thetreatment of patients with localized tumorsand other conditions susceptible totreatment by radiation.	PT2 Varian Proton Therapy System, providesprotons for precision radiotherapy oflesions, tumors, and conditions anywhere inthe body where radiation treatment isindicated.
Proton Accelerator	Isochronous Cyclotron (notsuperconducting)	Isochronous Cyclotron (superconductingtype using helium cryogen cooling)
Treatment Particle	Proton	Proton
Cyclotron energy	230 MeV	250 MeV
Proton Energy Selection	70-230 MeV	90-230 MeV (usable energy range)
Energy Selection	Via mechanical degrader system and EnergySelection System based on magneticdeflection	Via mechanical degrader system and EnergySelection System based on magneticdeflection
Beam Transport	Standard beam optical system withquadrupoles and dipole magnets	Standard beam optical system withquadrupoles and dipole magnets
Number of TreatmentRooms	3 to 7 treatment rooms with fixed beamtreatment stations or isocentric gantries.	1 to 4 treatment rooms with isocentricgantries.No fixed beam treatment stations.
Beam angle adjustment	Fixed in Fixed Beam treatment stationsor adjustable via Rotating Isocentric Gantry	Adjustable via Rotating Isocentric Gantry
Beam delivery	Beam Scattering orPencil Beam ScanningThe pencil beam scanning is defined as theact of moving a charged particle beam ofparticular properties and/or changing one ormore of the properties of that beam (e.g.Intensity (e.g. # protons/second), size (e.g. 1sigma), position etc.)	Beam Spot Scanning in all treatmentstationsThe beam spot scanning is defined as theact of moving a charged particle beam ofparticular properties from one spot to thenext over the whole treatment volumeand/or changing one or more of theproperties of that beam (e.g. Intensity (e.g. #protons/second), position etc.). Thecharged particle beam stops on each spotuntil the predefined the proton fluenceaccording to a prescription is reached andmoves to the next spot. After one layer ofspots is done the depth will be changed bythe change of the energy and the next layerof spots will be executed.
Patient Positioning	6-Axis Treatment Table	6-Axis Treatment Table
Patient PositionVerification System	Included	Not included
Laser positioning system	Included	Included

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

Summary of Performance Testing

Results of verification and validation testing demonstrate that the
PT2 Varian Proton Therapy System satisfies the intended use as described above.

را

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

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Vy Tran Official Correspondent Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

L. 2.7 ..

Re: K101294

Trade/Device Name: PT2 Varian Proton Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: September 17, 2010 Received: September 22, 2010

Dear Ms. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter 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 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

ンネ・、こなる・アミュ

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

Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The word "VARIAN" is in large, bold letters, with a stylized "i" that has a dot above it. Below the word "VARIAN" are the words "medical systems" in smaller letters.

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

Indications for Use Statement

DEC 27 2010

510(k) Number: KIO1294 Device Name:

PT2 Varian Proton Therapy System

PT2 Varian Proton Therapy System, provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatmont is indicated.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Beatler Exchilder (OBE) OFF OD

(Division Sign-Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K161294

Page 1 of 1

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.