The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT) for the treatment of cancer. The HI-ART System provides precise delivery of radiation to tumors while minimizing the delivery of radiation to vital healthy tissue.

The HI-ART System's planning station is intended to be used by the physician/oncologist to prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves.

The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing an MVCT scan (a CT using the onboard linear accelerator as the radiation source). This MVCT image will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The MVCT image is not for diagnostic use.

When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to confirm the selected treatment plan. The HI-ART System delivers the radiation therapy treatment in accordance with the physician approved plan using IMRT techniques delivered in a helical tomographic pattern.

Device Description

The TomoTherapy HI-ART System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT scanning, and helical radiation therapy treatment capabilities into a single comprehensive IMRT system.

The HI-ART System's planning station is used by the physician to prescribe and enter the radiation therapy plan. The patient's diagnostic CT image is imported via a DICOM protocol from another diagnostic CT device. The regions of interest, regions to avoid, and other prescribing information are entered in a manner that is similar to other commercially available planning systems.

The HI-ART System utilizes a 6 MV linear accelerator as the radiation source. The linear accelerator along with the primary collimator, multi-leaf collimator (MLC), xenon detector, various control devices and power supplies are mounted on a rotating gantry, much like a CT gantry. During treatment or imaging, the patient is positioned on the couch support, and the couch moves axially through the bore of the gantry, and the radiation is delivered in a helical pattern.

The primary collimator and the MLC control the beam dimensions during radiation delivery so that the range of collimated beam size can vary from 0 to 400 mm wide by 5 to 45 mm at the isocenter. The MLC is constructed of 64 tungsten leaves that open and close as determined by the radiation therapy plan. The intensity of the radiation beam is proportional to the length of time that a particular leaf is open. The opening and closing of various leaves as the radiation is delivered in this helical pattern allows for an IMRT plan to be delivered with precise control. The result is a highly conformal dose to the region of interest with low doses to surrounding healthy tissue.

Because the HI-ART System is operating in a helical mode similar to CT systems, it inherently has the ability to obtain a CT image. The system utilizes the linear accelerator to obtain a megavoltage (MVCT) scan of the region of interest prior to the delivery of radiation therapy. This MVCT image is then used in a non-diagnostic mode to ascertain that the patient is correctly positioned prior to treatment. The radiation dose to the patient from an MVCT scan is comparable to diagnostic CT or portal imaging.

AI/ML Overview

This document describes the TomoTherapy HI-ART System, a radiation therapy system designed for Intensity Modulated Radiation Therapy (IMRT) for cancer treatment. It integrates planning, dose calculation, megavoltage CT scanning (MVCT), and helical radiation therapy.

While the document thoroughly describes the device's intended use, its components, and safety considerations, it does not present specific acceptance criteria or a dedicated study explicitly designed to prove the device meets pre-defined acceptance criteria in the format requested.

Instead, the document focuses on:

Substantial Equivalence: The 510(k) submission successfully argues that the HI-ART System is substantially equivalent to legally marketed predicate devices, a common regulatory pathway for medical devices.
Validation and Verification Testing: It generally states that "The HI-ART System was extensively validated for system functionality, including planning, imaging, delivery, database management, DICOM communications, etc. Test tools utilized in this testing included IMRT phantoms, ion chambers and other test phantoms."

Therefore, many of the specific details requested regarding acceptance criteria and study design cannot be extracted from this document. The information provided is at a high level, confirming that validation activities occurred rather than detailing the specific criteria and results of those activities in a structured manner to demonstrate meeting acceptance criteria.

Below is an attempt to structure the available information, with many sections noted as "Not Provided" due to the nature of the submitted document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Provided	Not Provided
(Specific quantitative criteria like dose accuracy, image resolution, patient positioning accuracy, etc., and their corresponding performance metrics are not detailed in this document. The document states "extensive validation for system functionality" but does not list specific criteria or results.)

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

Sample Size: Not provided. The document mentions "IMRT phantoms, ion chambers and other test phantoms" were used as test tools, implying inanimate objects rather than patient data for acceptance testing.
Data Provenance: Not provided. Given the use of phantoms, the concept of "country of origin of the data" or "retrospective/prospective" does not directly apply to the primary validation described in the 510(k). If patient data was used for any part of the "extensive validation," its provenance is not stated.

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

Not Provided. The validation described appears to rely on physical measurements with phantoms and ion chambers, rather than expert-established ground truth on clinical images or patient data for the acceptance criteria demonstration. Therefore, the number and qualifications of experts for this purpose are not mentioned.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. Since the described validation primarily involves physical measurements using phantoms and instruments, and not, for example, image interpretation requiring expert consensus, an adjudication method for a test set is not relevant or described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not done (or not described). The document does not mention any MRMC study comparing human readers with and without AI assistance. The HI-ART system is a radiation delivery system, and its MVCT imaging component is explicitly stated as "not for diagnostic use," suggesting it's not primarily an AI-driven diagnostic imaging interpretation device that would typically undergo MRMC studies for reader improvement.

6. Standalone Performance Study

Implied, but details not provided. The general statement "The HI-ART System was extensively validated for system functionality" suggests that the system's various modules (planning, imaging, delivery, etc.) were tested for their inherent performance. However, specific standalone performance metrics or studies are not detailed in the document. The validation description focuses on the integrated system's functionality rather than a specific "algorithm only" component.

7. Type of Ground Truth Used

Physical Measurements / Reference Standards. For the validation noted, the ground truth would be based on the known properties and responses of "IMRT phantoms, ion chambers and other test phantoms," which serve as reference standards for dose delivery accuracy, beam characteristics, and imaging fidelity (though the MVCT is non-diagnostic). It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not Applicable / Not Provided. The TomoTherapy HI-ART System, as described, is a complex integrated hardware and software system for radiation therapy delivery. It's not presented as a machine learning or AI algorithm that undergoes "training" in the typical sense with a "training set" of data to learn patterns. Its functionality is based on physics models, control systems, and deterministic algorithms.

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

Not Applicable / Not Provided. As the system is not described as involving a machine learning "training set," the concept of establishing ground truth for such a set is not relevant to the information provided.

Summary

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KDI3673

JAN 2 8 2002

510(k) Safety and Effectiveness Summary Section 4

General Information 4.1

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).

Contact Person:	Kenneth D. BurokerTomoTherapy, Inc.2228 Evergreen Rd.Middleton, WI 53562
Phone:	(608) 824-0995
Fax:	(608) 824-0996
Date:	November 3, 2001
Device Trade Name:	HI-ART System
Common Name:	Radiation Therapy System
Classification Name:	Medical Charged Particle Radiation TherapySystem
Predicate Devices:	ADAC P3IMRT & Pinnacle 3K002237 & K993923
	Marconi AcQSim CTK923851
	GE 3D Advantage Windows FusionK983256
	Marconi AcQSim FusionK003437

Siemens Genesis IMRT K982502

4.2 Intended Use

The TomoTherapy HI-ART System is intended to be used as an integrated system for the The Tomornerapy 111 Tix Posity modulated radiation therapy (IMRT) for the treatment of cancer. The HI-ART System provides precise delivery of radiation to tumors while minimizing the delivery of radiation to vital healthy tissue.

The HI-ART System's planning station is intended to be used by the The FIFT System o prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves.

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The HI-ART system's operator station and status console is then intended to be used by the the rise to select and implement the patient's treatment plan. The treatment process will begin by performing an MVCT scan (a CT using the onboard linear accelerator as the radiation source). This MVCT image will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The MVCT image is not for diagnostic use.

When patient positioning is complete, the HI-ART System is then intended to be used by when patient poolitics to econfiring the selected treatment plan. The HI-ART System the uners the radiation therapy treatment in accordance with the physician approved plan using IMRT techniques delivered in a helical tomographic pattern.

4.3 Description

The HI-ART System utilizes a 6 MV linear accelerator as the radiation source. The Ine III TRY byeath along with the primary collimator, multi-leaf collimator (MLC), xenon detector, various control devices and power supplies are mounted on a rotating gantry, much like a CT gantry. During treatment or imaging, the patient is positioned on the couch support, and the couch moves axially through the bore of the gantry, and the radiation is delivered in a helical pattern.

Safety Considerations 4.4

The HI-ART System has several characteristics that promote its safety – no beam blocks are used that can fall off onto the patient; the rotating gantry is covered so that the patient cannot contact moving gantry parts; the linear accelerator operates in photon mode only

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so inadvertent electron exposure is virtually eliminated; MVCT allows for reliable patient positioning.

Also, the HI-ART System consists of components similar to those already commercially marketed, including the 6 MV linear accelerator, rotating gantry, patient couch and CT imaging devices.

Standards Compliance 4.5

The HI-ART System is designed to comply with relevant sections of the IEC 60601-1 series safety standards.

Validation 4.6

The HI-ART System was extensively validated for system functionality, including planning, imaging, delivery, database management, DICOM communications, etc. Test tools utilized in this testing included IMRT phantoms, ion chambers and other test phantoms.

4.7 Conclusion

Validation and verification testing of the HI-ART System demonstrate the device is safe and effective for its intended use. The HI-ART System is substantially equivalent to other commercially marketed systems for the various capabilities of the HI-ART

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract caduceus, featuring three wavy lines that converge to form a single point.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2002

Mr. Kenneth D. Buroker Director, Regulatory Affairs & Quality TomoTherapy, Inc. 2228 Evergreen Road MIDDLETON WI 53562-4241

Re: K013673

Trade/Device Name: TomoTherapy HI-ART System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: November 3, 2001 Received: November 6, 2001

Dear Mr. Buroker:

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 (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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I nis lotter will and in you ding 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 rr you desire 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. Brogdon

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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Indications for Use Form Section 3

Page 1 of 1

510(k) Number (if known) .
TomoTherapy HI-ART System Device Name: ●
Indications for use:
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and I ne Tomo Ineraly modulated radiation therapy (IMRT) for the treatment of cancer. The HI-ART System delivery of mielishy modulation therapy (thirs ) rerails the delivery of radiation to vital healthy tissue.

The HI-ART System's planning station is intended to be used by the physician/oncologist to prescribe a The III-ART Dystein 3 particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves.

The HI-ART system's operator station and status console is then intended to be used by the therapist to The 111-AN I system s operator station and plan. The treatment process will begin by performing an Sciect and implement the patient of deathern as the radiation source). This MVCT image will M VCT sean (a CT using the oneours intect for the radiation therapy as well as assist in patient reconfinin that the parties ary. The MVCT image is not for diagnostic use.

When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to when patient positioning is complete, the III Pan. The HI-ART System delivers the radiation therapy treatment in accordance with the physician approved plan using IMRT techniques delivered in a helical tomographic pattern.

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 810.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

David G. Symon

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.