The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician prescribed and approved plan.

Device Description

The TomoTherapy Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and helical (rotational) and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system. The TomoTherapy Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the TomoTherapy Treatment System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria (e.g., minimum accuracy percentages, maximum deviation values). Instead, it refers to general conformity to standards and design specifications. Therefore, the table below reflects the qualitative statements made in the document regarding performance.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Overall Performance	Conform to requirements of applicable recognized consensus standards for medical devices.	"The TomoTherapy Treatment System was tested and demonstrated to conform to the requirements of applicable recognized consensus standards for medical devices."
Functional Performance	Performance within design specifications for imaging and radiation delivery.	"Results of verification and validation tests, including extensive tests of imaging and radiation delivery functionality, confirm the TomoTherapy Treatment System performance is within design specifications."
Safety and Effectiveness	To be as safe and as effective as the predicate device.	"These performance data demonstrate the TomoTherapy Treatment System is as safe, as effective, and performs as well as the predicate device."
Dose Consistency	Improved consistency of dose rate compared to the predicate device (though not altering performance claims for the product).	"Enhancements to the radiation delivery system improve the consistency of the dose rate of the TomoTherapy Treatment System in comparison to the predicate device."
Dose Monitoring/Interlock	Operation of the independent dose monitoring/interlock system is completely unchanged from the predicate device, with identical functionality and limits.	"Therefore the dose monitoring/interlocks operation is identical to pre-existing functionality and performance limits."

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

Sample Size: The document does not specify a numerical sample size for the test set. It mentions "verification and validation tests, including extensive tests of imaging and radiation delivery functionality."
Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. It is a premarket notification for a medical device (510(k)), typically relying on engineering and bench tests for this type of submission rather than large-scale clinical studies.

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

The document does not mention the use of experts to establish "ground truth" in the context of diagnostic interpretation for the tests performed. The tests described are primarily focused on the engineering and physical performance of the radiation delivery system and imaging functionality, not on diagnostic accuracy requiring expert interpretation of images or patient outcomes.

4. Adjudication Method for the Test Set

As the tests described are technical performance evaluations rather than clinical assessments requiring human interpretation or decision-making, an adjudication method (like 2+1 or 3+1) is not applicable and therefore not mentioned in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests were required to establish substantial equivalence." The focus was on demonstrating substantial equivalence to a predicate device through technical performance data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence, standalone performance was assessed. The "verification and validation tests" for imaging and radiation delivery functionality would constitute evaluations of the system's performance without human intervention in the primary operational loop being tested (e.g., how accurately the system delivers radiation according to a plan, or how consistently the dose rate is maintained). The device's primary function is radiation delivery, not diagnostic interpretation by an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed would be established by engineering specifications, physical measurements, and recognized consensus standards. For example, the ground truth for dose consistency would be the expected dose output based on the physics of the system and calibration, measured against actual output. Similarly, imaging functionality would be assessed against expected image quality and resolution for megavoltage CT. There is no mention of pathology, outcomes data, or expert consensus related to diagnostic accuracy as the "ground truth" for these tests, as the device is not a diagnostic tool.

8. The Sample Size for the Training Set

The document does not specify a "training set" sample size. This type of device classification (510(k) for a radiation therapy system) generally does not involve machine learning algorithms that require a distinct training set in the way a diagnostic AI would. The performance data comes from verification and validation of the hardware and software systems.

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

As no specific "training set" for an AI algorithm is indicated, the concept of establishing ground truth for it is not applicable or mentioned in this document. The system's operation is based on pre-defined physics models and engineering designs, not learned patterns from a training dataset like a typical AI diagnostic tool.

Summary

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OCT - 7 2011

erapy

Section 2 510(k) Summary

Applicant:

TomoTherapy, Inc. 1209 Deming Way Madison, WI 53717-1954 Phone: 608.824.2800 Fax: 608.824.2981 Contact:

	Gregory G. Bange
	gbange@accuray.com
ared:	August 19, 2011

Date Prepared:

Device Identification:

Device Name:	TomoTherapy Treatment System
Trade Names	Hi-Art® and TomoHD TM
Common Name:	Radiation Therapy System
Classification:	System, Planning, Radiation Therapy Treatment
Product Code:	MUJ, IYE
Regulation Number:	21 CFR 892.5050
Regulation Description:	Medical charged particle radiation therapy system

Predicate Device:

TomoTherapy Hi-Art System (modified) K082005

Description:

The TomoTherapy Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, rccommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.

Intended Use:

The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, nonrotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

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Technological Characteristics:

The technological characteristics of the TomoTherapy Treatment System are substantially equivalent to the predicate. The TomoTherapy Treatment System consists of the same primary subassemblies, is comparable in key safety and effectiveness features, utilizes substantially similar design, construction, materials, energies, and it has an intended use that is identical to that of the predicate device. It is important to note that while this addition addresses consistency of dose output, the operation of the independent dose monitoring/interlock system is completely unchanged. Therefore the dose monitoring/interlocks operation is identical to pre-existing functionality and performance limits.

Enhancements to the radiation delivery system improve the consistency of the dose rate of the TomoTherapy Treatment System in comparison to the predicate device. This does not alter the performance claims for the product. These technological enhancements do not raise new type of safety or effectiveness questions.

Performance Data:

The TomoTherapy Treatment System was tested and demonstrated to conform to the requirements of applicable recognized consensus standards for medical devices. Results of verification and validation tests, including extensive tests of imaging and radiation delivery functionality, confirm the TomoTherapy Treatment System performance is within design specifications. No clinical tests were required to establish substantial equivalence. These performance data demonstrate the TomoTherapy Treatment System is as safe, as effective, and performs as well as the predicate device.

Summary:

The TomoTherapy Treatment System is substantially equivalent to the predicate device. The intended use, major technological characteristics, and principles of operation of the TomoTherapy Treatment System are identical to those of the predicate device. Minor technological differences do not raise new types of safety or effectiveness questions. Performance data demonstrate the TomoTherapy Treatment System is as safe, as effective, and performs as well as the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human form, with three curved lines extending upwards from the body.

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

Mr. Greg Bange Manager of Regulatory Submissions and Standards TomoTherapy, Inc. 1240 Deming Way MADISON WI 53717-1954

OCT - 7 2011

Re: K112446

Trade/Device Name: TomoTherpy Treatment System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: August 19, 2011 Received: August 24, 2011

Dear Mr. Bange:

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

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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 5100k) 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 1 809), 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.

Mary Patel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Section 1 Indications for Use Form

510(k) Number (if known):

KI12446

Device Name:

TomoTherapy Treatment System

Indications for use:

Prescription Use X (Per 21 CFR 801 subpart D)

AND/OR

Over-the-Counter Use (Per 21 CFR 801 subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD)

Muhaf D.O.H
Division Sign Off

Division Sign-Off Office of In-Vitro Diagnostic Device Evaluation and Safety

510(k) K112446

Page 1 of _

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.