The TomoTherapy HI-ART 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 approved plan.

Device Description

The TomoTherapy HI-ART System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT scanning for IGRT functionality, and helical radiation therapy treatment capabilities into a single comprehensive system. The megavoltage CT image is not for diagnostic use. This modification provides a licensable option that adds the capability for fixed beam treatments from multiple user defined angles as well.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the TomoTherapy HI-ART System, which is a radiation therapy system. It describes the device, its intended use, safety considerations, and compliance with standards. However, it does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a study in the way typically required for AI/ML-based medical devices.

The document is a traditional 510(k) submission for a modified radiation therapy system, not for an AI/ML-based diagnostic or prognostic device that would involve performance metrics like sensitivity, specificity, or reader studies. The validation section mentions "system functionality, including planning, imaging, delivery, database management, DICOM communications, etc." and that "Test tools utilized in this testing included IMRT phantoms, ion chambers and other test phantoms." This indicates performance validation against physical phantoms and established engineering/system metrics, rather than clinical performance based on patient data and ground truth as would be the case for an AI/ML device.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity) for clinical outcomes in the provided text. The document refers to compliance with safety standards and system functionality.
Reported Device Performance: Not detailed in terms of clinical performance metrics. It mentions validation using IMRT phantoms and ion chambers, implying physical measurement of radiation delivery accuracy and dose calculation, but specific numerical results or criteria are not provided.

2. Sample size used for the test set and the data provenance: Not applicable in the context of clinical data for AI/ML. The validation involved test tools like phantoms.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for phantoms is typically derived from physical measurements and established parameters, not expert consensus on clinical findings.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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. This is not an AI/ML device, and no MRMC study is mentioned. The device assists in planning and delivering radiation, not in interpreting medical images or making diagnoses.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a system with human-in-the-loop for planning and operation. The validation concerns the system's performance, not an isolated algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the described validation, the ground truth would be based on physical measurements of dose, system functionality, and compliance with engineering specifications when tested with phantoms and other test tools. It is not clinical ground truth from patient data.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data in the computational sense.

9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

Feature/Criterion	Details from Provided Text
1. Acceptance Criteria & Reported Device Performance	Acceptance Criteria: The device design complies with relevant sections of IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-32, IEC 60601-2-44, IEC 61217, EN ISO 14971:2007, and IEC TR 62266 safety standards. There are no explicit quantitative performance metrics for clinical outcomes (e.g., sensitivity, specificity) mentioned. The validation aimed to demonstrate the device is "safe and effective for its intended use" through system functionality testing. Reported Device Performance: Validation included "system functionality, including planning, imaging, delivery, database management, DICOM communications, etc." No specific numerical performance values are provided.
2. Sample size for test set & data provenance	Not applicable for clinical data. Validation involved "IMRT phantoms, ion chambers and other test phantoms." The 'sample size' would pertain to the set of tests conducted on these physical phantoms.
3. Number of experts & qualifications for ground truth	Not applicable. Ground truth for phantom testing is based on known physical properties and measurements, not expert consensus on clinical findings.
4. Adjudication method for test set	Not applicable.
5. MRMC comparative effectiveness study	No. This document does not describe an AI/ML device or an MRMC study.
6. Standalone (algorithm only) performance study	Not applicable. The device is an integrated system (hardware and software) with human-in-the-loop operation for radiation therapy planning and delivery.
7. Type of ground truth used	For the validation described, the ground truth would be based on established physical measurements and engineering specifications for system components when tested with IMRT phantoms and ion chambers. It is not expert consensus, pathology, or outcomes data from patients.
8. Sample size for training set	Not applicable. This is not an AI/ML device that undergoes a training phase with a dataset.
9. How ground truth for training set was established	Not applicable.

Conclusion:

The provided document describes a 510(k) submission for a conventional medical device (radiation therapy system) with modifications, not an AI/ML-driven device. Therefore, the request for detailed information on acceptance criteria, reader studies, and training/test set specifics, which are typical for AI/ML device evaluations, cannot be fulfilled from this text. The "study" mentioned is a system validation against engineering standards and physical test phantoms, rather than a clinical performance study with patient data and expert ground truth.

Summary

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Korzoos

AUG 2 5 2008

Section 4 510(k) Safety and Effectiveness Summary

4.1 General Information

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

Contact Person:	Robert BovyTomoTherapy, Inc.1240 Deming WayMadison, WI 53717-1954
Phone:	(608) 824-2938
Fax:	(608) 830-3771
Date:	July 7, 2008
Device Trade Name:	HI-ART System (modified)
Common Name:	Radiation Therapy System
Classification Name:	Medical Charged Particle Radiation TherapySystem
Predicate Devices:	TomoTherapy Hi-Art SystemK060912
	Varian Clinac 600K026321

4.2 Intended Use

4.3 Description

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Safety Considerations 4.4

The HI-ART System has several inherent 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 eliminated; MVCT allows for reliable patient positioning. This modification introduces no new fundamental technical characteristics or safety concerns.

Standards Compliance 4.5

The HI-ART System is designed to comply with relevant sections of the IEC 60601-1. 1EC 60601-2-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-32, IEC 60601-2-44, IEC 61217, EN ISO 14971:2007, and IEC TR 62266 safety standards.

4.6 Validation

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 demonstrates the device is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2008

Mr. Robert Bovy Director of Regulatory Affairs TomoTherapy Incorporated 1240 Deming Way MADISON WI 53717-1954

Re: K082005

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: MUJ Dated: July 8, 2008 Received: July 14, 2008

Dear Mr. Bovy:

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.

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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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.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

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Indications for Use Form Section 3

510(k) Number (if known)
Ko82005

Device Name:

TomoTherapy HI-ART System

Indications for use:
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and The Tomor Horapy TIT THEF Uystein is tereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage xray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 810.109)

Over-the-Counter Use

Arge Mmhly
(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.