The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

Device Description

The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.

The Radixact Treatment Delivery System is an updated design of the radiation delivery elements of the predicate TomoTherapy Treatment System (last cleared on K121934). The Radixact Treatment Delivery System delivers radiation therapy treatment plans generated on planning systems such as Accuray's Precision™ Treatment Planning System and stored on Accuray's iDMS™ Integrated Data Management System devices. The planning and data management devices are not addressed in this 510(k).

The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. As with the TomoTherapy Treatment System, the Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, it is not intended for diagnostic use.

AI/ML Overview

This document does not contain an acceptance criteria table or a study description with the requested details. The primary purpose of this document is a 510(k) premarket notification for the Radixact Treatment Delivery System, asserting its substantial equivalence to a predicate device (TomoTherapy Treatment System, K121934).

Here's a breakdown of what is and is not in the provided text, in relation to your request:

1. A table of acceptance criteria and the reported device performance:

Not Found: The document does not present a table of specific quantitative acceptance criteria or detailed reported device performance metrics in the format requested.
What is present: There is a detailed comparison table (pages 5-6) that highlights "General Characteristics" of the predicate device and the subject device (Radixact Treatment Delivery System). This table focuses on technological characteristics (e.g., dimensions, gantry features, radiation delivery modes, imaging parameters, patient couch motion) and largely states "Identical to predicate" or "Functionally equivalent to predicate" for many parameters, or provides specific values for both devices without explicitly stating "acceptance criteria" or a quantitative "performance result" against a pre-defined threshold.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Found: The document states, "No clinical tests were required to establish substantial equivalence" (page 8). Therefore, there is no mention of a test set, its sample size, or data provenance from a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Found: As no clinical tests were required, there is no information about experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Found: No clinical tests, no adjudication method.

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:

Not Found: No MRMC study was conducted or mentioned, as the device is a radiation therapy delivery system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Found: Not applicable for this type of device. The device itself delivers radiation therapy as directed by a practitioner, it's not an algorithm providing a standalone diagnostic or treatment recommendation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not Found: Since no clinical studies were performed for this 510(k), no ground truth establishment is discussed. The device's "performance" is assessed through engineering verification and validation testing against design specifications, conformity to recognized consensus safety standards, and comparison of technological characteristics to the predicate.

8. The sample size for the training set:

Not Found: This device is a hardware system for radiation delivery, not a machine learning model that would require a "training set" in the conventional sense.

9. How the ground truth for the training set was established:

Not Found: Not applicable, as it's not an AI/ML device that uses a training set with ground truth.

In summary:

The provided document is a 510(k) summary focused on demonstrating the substantial equivalence of the Radixact Treatment Delivery System to a predicate device. It relies heavily on comparing technical specifications, intended use, and functioning principles, and states that "No clinical tests were required to establish substantial equivalence" (page 8). Therefore, it does not contain the detailed information about acceptance criteria, clinical study methodology, sample sizes, or ground truth establishment that you've requested, as these were not part of the substantial equivalence pathway for this particular device submission. The performance data mentioned refers to "verification and validation testing confirm[ing] that the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users" (page 8), rather than clinical study results.

Summary

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

June 24, 2016

Accuray Incorporated % Mr. Keith Picker Regulatory Affairs Specialist 1209 Deming Way MADISON WI 53717

Re: K161146

Trade/Device Name: Radixact Treatment Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 22, 2016 Received: April 22, 2016

Dear Mr. Picker:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161146

Device Name

Radixact Treatment Delivery System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 8 510(k) Summary

Submitter

Accuray Incorporated 1209 Deming Way Madison, WI 53717-1954 Phone: 608-824-2800 Fax: 608-824-2996

Contact:	Keith Picker
Date Prepared:	April 25, 2016

Device Identification

Device Name: Trade & Brand Names: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:

Radixact Treatment Delivery System Radixact Treatment Delivery System Radiation Therapy System 21 CFR 892.5050 Medical charged-particle radiation therapy system Class II IYE

Predicate Device

TomoTherapy Treatment System (K121934)

Device Description

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treatment regimens or quantify treatment effectiveness. Accordingly, it is not intended for diagnostic use.

Intended Use

The Radixact Treatment Delivery System is intended to be used for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues. The megavoltage x-ray radiation is delivered using rotational, nonrotational, intensity modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) treatment techniques and using image-guided (IGRT) or non-image-guided workflows in accordance with the physician approved plan.

Indications for Use

While the indications for use of the Radixact Treatment Delivery System are stated slightly differently from those of the predicate, the differences are not critical to the intended use of the devices nor do they affect the safety and/or effectiveness of the new device as compared to the predicate device. Both devices provide the same types of radiation therapy.

Technological Characteristics

The Radixact Treatment Delivery System has imaging and treatment capabilities equivalent to those of the predicate TomoTherapy Treatment System. It also has a similar functionally-equivalent CT style gantry and patient couch. Further, the clinical workflow is the same as that of the predicate TomoTherapy Treatment System.

The Radixact Treatment Delivery System and the predicate device employ the same fundamental scientific principles, and have substantially equivalent technological characteristics and principles of operation. The main difference between the predicate TomoTherapy Treatment System and the Radixact Treatment Delivery System is that the predicate includes integral treatment planning and data management subsystems, whereas the Radixact Treatment Delivery System is strictly a radiation treatment delivery device.

Where there are technological differences between the Radixact Treatment Delivery System and the predicate device, those differences do not raise different questions of safety or effectiveness.

A table comparing the predicate cleared on K121934 and the Radixact Treatment Delivery System is presented below:

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General Characteristics	Predicate DeviceTomoTherapyTreatment System(K121934)	Subject DeviceRadixactTreatment Delivery System
System Configuration	Radiation delivery systemintegrated with data managementsystem and planning system	Stand alone radiation deliverysystem (does not include datamanagement system orplanning system)
Vault
Min. Room Dimensions
Height*	270 cm	274 cm**
Width*	462 cm	462 cm**
Length*	596 cm	602 cm**
Device Dimensions(gantry and couch)
Height*	252 cm	255 cm**
Width*	280 cm	280 cm**
Length*	466 cm	473 cm**
Weight	4,943 kg	6580 kg**
Environment
Line Voltage	380-480V, 3-Phase	Identical to predicate
Ambient RoomTemperature	68-75 °F (20-24 °C)	Identical to predicate
Relative Humidity	30%-60%, non-condensing	Identical to predicate

Gantry MechanicalFeatures
Degrees of Rotation	Continuous rotation around Y-axis (axes per IEC 61217)	Identical to predicate
Direction of Rotation	Clockwise	Identical to predicate
Bore Size	85 cm diameter	Identical to predicate
Speed of RotationTreatmentImaging	1 to 5 RPM6 RPM	Identical to predicate10 RPM
Couch Support in Bore	Not provided	Provided
Radiation DeliveryModes	HelicalDirect	Identical to predicateIdentical to predicate
Photon Beam
Accelerator Type	Standing wave	Identical to predicate
RF Source	Magnetron	Identical to predicate
Nominal Energy	6 MV	Identical to predicate
Fixed Field Size	1.0 cm x 40 cm2.5 cm x 40 cm5.0 cm x 40 cm	Identical to predicateIdentical to predicateIdentical to predicate
Dynamic Field Size	1.0 - 2.5 cm x 40 cm1.0 - 5.0 cm x 40 cm	Identical to predicateIdentical to predicate
Dose Rate	850 cGy/min	850 cGy/min or 1000 cGy/minoptions
Collimation	Primary collimation, jaws andmulti-leaf collimator (MLC)	Identical to predicate
General Characteristics	Predicate DeviceTomoTherapyTreatment System(K121934)	Subject DeviceRadixactTreatment Delivery System
Imaging
Field of View	39 cm diameter	Identical to predicate
Dose per MVCT image(typical)	0.5 - 3.0 cGy	Identical to predicate
Slice spacing	1, 2, 3, 4 and 6 mmreconstruction intervals	Identical to predicate
Spatial Resolution	1.6 mm spatial resolution	Identical to predicate
Laser System
Stationary	Green lasers, identify virtual andactual isocenter	Identical to predicate
Moveable(for patientpositioning andregistration)	Red lasers, offset from virtualisocenter	Identical to predicate
Patient Couch
Biocompatibility	Carbon-fiber top	Equivalent to predicate
MotionX-axisY-axisZ-axis	Independent of other axesCoupled with Z-axis(via couch Cobra motion)Coupled with Y-axis(via couch Cobra motion)	Identical to predicateIndependent of other axesIndependent of other axes
Power Distribution
Isolation	Transformer	Equivalent to predicate
UPS for Data Back-up	Provided	Equivalent to predicate
General Characteristics	Predicate DeviceTomoTherapyTreatment System(K121934)	Subject DeviceRadixactTreatment Delivery System
Operator Station	User interface to systemfunctions (i.e., patient andprocedure selection, andprocedure delivery)	Functionally equivalent topredicate
Machine ControlSoftware	Controls radiation delivery andpositioning systems (referred toas the RDS - Radiation DeliverySystem)	Functionally equivalent topredicate (referred to as theECS – Embedded ControlsSubsystem)
Data InterfacesOperator Station	Provides measurements andstatus during operation	Functionally equivalent topredicate
Database	Integrated database used forgathering operational data andstorage of procedure data	Works with functionally-equivalent external database
Safety Features	Interlock SubsystemsData integrity checking	Functionally equivalent topredicateFunctionally equivalent topredicate

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Dimensions are rounded to the nearest centimeter.

** Information Source: Radixact Site Planning Guide T-SPG-01000, Rev A.

Performance Data

The Radixact Treatment Delivery System was tested and shown to be in compliance with the requirements of applicable recognized consensus safety standards for medical devices. Results of verification and validation testing confirm that the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users. No clinical tests were required to establish substantial equivalence. The performance data demonstrate that the Radixact Treatment Delivery System is as safe and effective, and performs as well as the predicate device.

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Conclusion

The Radixact Treatment Delivery System is substantially equivalent to the predicate The intended use, major technological characteristics and the principles of device. operation of the Radixact Treatment Delivery System are substantially equivalent to those of the predicate device. Minor differences do not raise different questions of safety and effectiveness of the Radixact Treatment Delivery System in comparison to the predicate device. Further, performance data demonstrate that the Radixact Treatment Delivery System is as safe and effective, and performs as well as the predicate device. Accordingly, the Radixact Treatment Delivery System is substantially equivalent to the predicate device.

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.