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 a TomoImage™ (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The Tomolmage (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 treat the patient using 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 50 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

Acceptance Criteria and Device Performance Study for the TomoTherapy HI-ART System

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K033347) is a 510(k) summary for a modified TomoTherapy HI-ART System. As such, it does not explicitly state acceptance criteria in a quantitative table format with corresponding performance metrics as would typically be found in a detailed clinical study report. Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (TomoTherapy Hi-Art System K013673) and confirming the device's safety and effectiveness for its intended use through extensive validation testing.

However, based on the information provided, we can infer the general areas of "acceptance criteria" through the descriptions of the device's intended function and the validation methods. The "reported device performance" is then described in broad terms as successful validation.

Feature/Function	Implicit Acceptance Criteria (based on intended use & validation)	Reported Device Performance
Planning Station	Accurately prescribes and enters radiation therapy plans; similar functionality to other systems.	"The HI-ART System was extensively validated for system functionality, including planning... " (Page 2). "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." (Page 0, Intended Use). Implies successful calculation and physician approval.
Dose Calculation	Provides accurate dose calculations for IMRT.	"The HI-ART System was extensively validated for system functionality, including... dose calculation..." (Page 2). "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." (Page 0, Intended Use). This implies the dose calculation is accurate enough to enable physician-approved treatment delivery.
Megavoltage CT (MVCT) Scan (TomoImage™)	Confirms correct patient positioning; assists in repositioning; not for diagnostic use.	"The HI-ART System was extensively validated for system functionality, including... imaging..." (Page 2). "This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient repositioning when necessary. The TomoImage (MVCT image) is not for diagnostic use." (Page 0, Intended Use). "MVCT allows for reliable patient positioning." (Page 1, Safety Considerations).
Radiation Therapy Delivery (IMRT)	Delivers precise radiation to tumors while minimizing exposure to healthy tissue, in a helical pattern.	"The HI-ART System was extensively validated for system functionality, including... delivery..." (Page 2). "The HI-ART System provides precise delivery of radiation to tumors while minimizing the delivery of radiation to vital healthy tissue." (Page 0, Intended Use). "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." (Page 0, Intended Use). "The result is a highly conformal dose to the region of interest with low doses to surrounding healthy tissue." (Page 1, Description).
System Functionality (General)	Reliable operation of integrated components (planning, imaging, delivery, database, DICOM).	"The HI-ART System was extensively validated for system functionality, including planning, imaging, delivery, database management, DICOM communications, etc." (Page 2). This indicates all these functionalities met their intended requirements.
Safety	Complies with relevant IEC safety standards; promotes patient safety (no falling blocks, covered gantry, photon mode only).	"The HI-ART System is designed to comply with relevant sections of the IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 60601-1-4 safety standards." (Page 1, Standards Compliance). "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 so inadvertent electron exposure is virtually eliminated: MVCT allows for reliable patient positioning." (Page 1, Safety Considerations).

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

Sample Size: The document does not specify a "test set" in terms of patient data. The validation relied on "test tools" such as "IMRT phantoms, ion chambers and other test phantoms" (Page 2). Therefore, the sample size refers to the number of tests performed using these phantoms, which is not quantified.
Data Provenance: The study described is a device validation study performed by the manufacturer (TomoTherapy Incorporated). It is an internal, retrospective validation using specified test tools, not prospective clinical data from human subjects. The data is not from a specific country of origin in terms of patient population, as it involves phantoms.

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

The document does not describe the use of "experts" to establish ground truth in the context of a clinical study or image review. The "ground truth" for the device's technical performance (e.g., dose delivery accuracy, image quality for positioning) was established through measurements with physical phantoms and established measurement devices (ion chambers).
The validation process would have been overseen by engineers, physicists, and quality assurance personnel within TomoTherapy Incorporated, whose qualifications are not detailed in this summary but would be relevant to radiation therapy device development and testing.

4. Adjudication Method for the Test Set:

No adjudication method (like 2+1, 3+1 consensus) is mentioned or applicable, as the validation was based on physical measurements of device output against established standards and expected performance, rather than human review of cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No MRMC comparative effectiveness study was done. The HI-ART System is a radiation therapy delivery system, not an AI-assisted diagnostic or image interpretation tool for human readers in the traditional sense. Its "AI" or advanced component is the intensity-modulated radiation therapy (IMRT) plan calculation and delivery, which is integral to its function, not a separate assistance tool for human interpretation.

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

The validation described is essentially a standalone performance assessment of the device's technical functionalities (planning, imaging, delivery, etc.) through testing with phantoms and measurements. The "algorithm only" aspect refers to the planning and dose calculation algorithms within the system, which were tested for accuracy and functionality.
However, the device is explicitly designed for "human-in-the-loop" operation: a "physician/oncologist" prescribes the plan, reviews, and approves it, and a "therapist" selects and implements the plan, performs the MVCT scan, and treats the patient (Page 0, Intended Use). The validation ensures these components (algorithms and hardware) function correctly when used by qualified personnel as intended.

7. The Type of Ground Truth Used:

The "ground truth" used for this validation study was physical measurements and established scientific principles related to radiation dose delivery, image quality for positioning, and system functionality. This involved:
- IMRT phantoms: Used to simulate patient anatomy and allow for precise dose measurements in a controlled environment.
- Ion chambers: Standard devices for measuring radiation dose, providing objective quantitative data.
- Other test phantoms: For various aspects of system performance.
- Compliance with IEC safety standards (Page 1).

8. The Sample Size for the Training Set:

The concept of a "training set" in the context of machine learning or AI algorithm development is not directly applicable here. The document describes a traditional medical device validation for a radiation therapy system, not a study focused on a deep learning model. The system's design and algorithms would have been developed over time, incorporating engineering principles and potentially internal iterations and refinements, but not typically a discrete "training set" phase as seen in current AI development.

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

As a "training set" is not explicitly mentioned or relevant in the context of this 510(k) summary for a modified radiation therapy system (not an explicit AI/ML device), the method for establishing its ground truth is not applicable to the information provided. The development of such a complex system would involve extensive engineering, physics, and clinical input during its design and optimization phases.

Summary

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1.4

1240 Deming Way Madison, WI 53717-1954 608.824.2800

fax 608.824.2996

ww.tomotherapy.con

NOV 1 2 2003

Ko33347

Image /page/0/Picture/6 description: The image contains the text "Safety and Effectiveness Summary" in a bold, sans-serif font. The text is centered horizontally and appears to be the title or heading of a document or section. The words are stacked on top of each other, with "Safety and Effectiveness" on the first line and "Summary" on the second line.

GENERAL INFORMATION

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 Incorporated1240 Deming WayMadison, WI 53717-1954
Phone:	(608) 824-2811
Fax:	(608) 824-2996
Date:	October 17, 2003
Device Trade Name:	HI-ART System (modified)
Common Name:	Radiation Therapy System
Classification Name:	Medical Charged Particle Radiation TherapySystem
Predicate Devices:	TomoTherapy Hi-Art SystemK013673

INTENDED USE

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 a TomoImage™ (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient repositioning when necessary. The TomoImage (MVCT image) is not for diagnostic use.

Image /page/0/Picture/15 description: The image shows the logo for TomoTherapy Incorporated. The logo features a stylized, abstract symbol above the company name. The symbol is a circular shape with a section cut out, and a star-like element is visible within the cutout. The text "TomoTherapy" is in a bold, sans-serif font, with "INCORPORATED" in a smaller font size below it.

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1240 Deming Way Madison, WI 53717-1954 608.824.2800 fax 608.824.2996

Image /page/1/Picture/2 description: The image is a black and white photograph. The majority of the image is black, with a large white circle in the upper left corner. The white circle is slightly irregular in shape, and it appears to be a light source. The black background is uniform and featureless, except for a few small white specks. The image is simple and abstract, with a strong contrast between the black and white elements.

www.tomotherapy.com

KC333477

Image /page/1/Picture/5 description: The image is a logo for TomoTherapy Incorporated. The logo features a stylized, abstract symbol above the company name. The symbol appears to be a three-dimensional shape with a curved, circular element and a pointed extension, creating a dynamic and modern look. The company name, "TomoTherapy," is printed in a bold, sans-serif font, with "INCORPORATED" in a smaller font size below.

SAFETY CONSIDERATIONS

DESCRIPTION

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 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

The HI-ART System is designed to comply with relevant sections of the IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 60601-1-4 safety standards.

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1240 Deming Way Madison, WI 53717-1954 608.824.2800

fax 608.824.2996

www.tomotherapy.com

Image /page/2/Picture/4 description: The image shows a conclusion statement. The conclusion states that validation and verification testing of the HI-ART System demonstrates the device is safe and effective for its intended use. The HI-ART System with modifications is substantially equivalent to the HI-ART system.

VALIDATION

phantoms.

K033347

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

Image /page/2/Picture/5 description: The image shows the logo for TomoTherapy Incorporated. The logo features a stylized, abstract symbol above the company name. The symbol appears to be a circular shape with a cut-out section, giving it a dynamic and modern look. The text "TomoTherapy" is in a bold, sans-serif font, with "INCORPORATED" in a smaller font size below it.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2003

Mr. Kenneth D. Buroker Director, Regulatory Affairs & Quality TomoTherapy Incorporated 1240 Deming Way MADISON WI 53717

Re: K033347

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 IYE and MUJ Dated: October 17, 2003 Received: October 20, 2003

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 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.

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 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 the 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" (21CFR Part 807.97) you may obtain. 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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1.3 Indications for Use Form

Page 1 of 1

. 510(k) Number (if known)

KU33347

. Device Name: TomoTherapy HI-ART System (modified)

. Indications for use:
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.

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)

Over-the-Counter Use

Nancy C. Brogdon

510(k) Num

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.