The Motion Tracking and Compensation Feature is an option within the indications for use of the Radixact Treatment Delivery System. 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 Motion Tracking and Compensation Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The Motion Tracking and Compensation Feature measures tumor location and motion using images provided by a kV imaging subsystem and predicts tumor location based upon a respiration amplitude measurement device. The Radixact Treatment Delivery System then compensates for tumor motion by making real-time adjustments.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a new feature (Motion Tracking and Compensation Feature) for an existing device (Radixact Treatment Delivery System). The core of the submission is to demonstrate substantial equivalence to the predicate device, not necessarily to provide specific performance metrics against pre-defined acceptance criteria in the way one might for a diagnostic AI device.

Therefore, the response below will focus on what is available in the text regarding "acceptance criteria" (more accurately, the claims of substantial equivalence) and the "study" (the verification and validation testing) that supports these claims, rather than a typical AI performance table.

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

For a substantial equivalence submission, the "acceptance criteria" are typically demonstrating that the new device feature does not raise new questions of safety or effectiveness compared to a predicate device, and performs as well as the predicate for its intended use. The table below summarizes the claims of substantial equivalence for various characteristics.

Device Characteristic	Predicate Device Performance (Radixact K161146)	Reported Device Performance (Radixact with Motion Tracking and Compensation)	Acceptance Criteria Met? (Analysis)
Intended Use	Delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues.	Option within the intended use of the Radixact Treatment Delivery System. Intended for delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues.	Identical: The device's intended use fits within and is identical to the predicate's.
Indications for Use	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.	Option within the indications for use of the Radixact Treatment Delivery System. Indicated for 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.	Identical: The device's indications for use fit within and are identical to the predicate's, with the addition of an introductory sentence for the feature.
System Configuration	Stand-alone radiation delivery system.	Stand-alone radiation delivery system with kV imaging and motion tracking and compensation added.	Substantially Equivalent: Introduction of Motion Tracking and Compensation Feature does not raise different issues of safety or effectiveness.
Physical Dimensions	Minimum Room Dimensions: 274 x 462 x 602 cm; Device Dimensions: 255 x 280 x 473 cm; Device Mass: 6580 kg.	Minimum Room Dimensions: 274.3 x 463 x 602 cm; Device Dimensions: 255 x 280 x 470.5 cm; Device Mass: 6580 kg plus 235 kg for kV subsystem components.	Substantially Equivalent: Minor differences are negligible or the added weight/components do not result in different questions of safety or effectiveness.
Basic Operation Parameters (Electrical, Environmental, Gantry)	Line Voltage: 380-480 V ac; Ambient Temp: 20-24 °C; Humidity: 30-60%; Bore Diameter: 85 cm; Gantry Rotation Continuous (1-5 RPM treatment, 10 RPM imaging); Couch Support in Bore: Provided.	Same as predicate.	Identical.
Radiation Delivery Modes	Helical, Direct.	Same as predicate.	Identical.
Photon Beam (Accelerator Type, RF Source, Energy, Field Size, Dose Rate)	Standing wave, Magnetron, 6 MV, Fixed/Dynamic Field Sizes, Dose Rate: 850 cGy/min standard, 1000 cGy/min optional.	Same as predicate.	Identical.
Collimation	Primary collimation, jaws and multi-leaf collimator.	Primary collimation, jaws and multi-leaf collimator.	Substantially Equivalent: Jaws have a new dynamic behavior for motion managed plans, continually adjusted to repoint the beam at the moving target while maintaining the same field size. This difference does not raise different questions of safety or effectiveness.
MVCT Imaging	Source: MVCT; FOV: 39 cm diameter; Dose: 0.5-3.0 cGy; Slice Spacing: 1, 2, 3, 4, 6 mm; Spatial Resolution: 1.6 mm.	Same as predicate.	Identical.
kV Imaging	Feature not present.	50-150 kV Radiography Class I (60601-2-28) X-ray tube assembly; FOV: 20 cm x 20 cm; Spatial Resolution: < 1 mm; Approx Dose: 0.08-0.20 mGy; Small Focal Spot: 0.6 mm x 0.6 mm; Large Focus Spot: 1.0 mm x 1.0 mm; Current Range: 5-500 mA.	Substantially Equivalent: New feature provides two-dimensional low-dose radiographic images for patient alignment and tumor motion measurement. Functionality provided by hardware and driver software, meeting safety requirements (IEC 60601 series). No new questions of safety or effectiveness.
Motion Management	Not present (Tracking Algorithm, Compensation Algorithm, Synchrony Camera).	Tracking Algorithm: Radixact Motion Tracking; Compensation Algorithm: Radixact Motion Compensation; Synchrony Camera: Radixact Synchrony Motion Tracking.	Substantially Equivalent: Tracking algorithm based on K120233 (Synchrony Respiratory Tracking System). Compensation algorithm uses jaws and MLC effectively, similar to K120233. Synchrony camera has been in use for over ten years (K120233). Do not result in different questions of safety or effectiveness.
Laser System	Stationary (Green lasers for virtual/actual isocenter); Moveable (Red lasers for offset from virtual isocenter).	Substantially equivalent.	Substantially Equivalent: Minor differences are negligible and do not result in different questions of safety or effectiveness.
Patient Couch	Motion: Independent of each of the other axes.	Same as predicate.	Identical.
Biocompatibility	Couch Top: Carbon-fiber top; Synchrony Vest: Not used.	Couch Top: Carbon-fiber top; Synchrony Vest: Same vest cleared under K120233.	Identical/No new biocompatibility issues: Couch top is identical. The Synchrony Vest is a previously cleared component, introducing no new biocompatibility concerns.
Power Distribution	Isolation Transformer: Provided; UPS for Data Back-up: Provided.	Same as predicate.	Substantially Equivalent: Introduction of Motion Tracking and Compensation Feature did not introduce changes to this subsystem.
Operator Station & Machine Control Software	User interface to system functions; Controls radiation delivery and positioning systems; Provides measurements and status.	Same as predicate.	Identical.
Database	External database for gathering operational data and storage of procedure data.	Same as predicate.	Identical.
Safety Features	Interlock Subsystems: Present; Data integrity checking: Present.	Interlock Subsystems: Present; Data integrity checking: Present.	Substantially Equivalent: kV subsystem integrated into safety interlocks; no new issues. Motion Tracking and Compensation Feature does not modify data integrity checking design.

2. Sample size used for the test set and the data provenance

The document states: "No animal or clinical tests were required to establish substantial equivalence with the predicate device." This indicates that the evaluations were likely based on bench testing, engineering verification, and validation activities rather than clinical data with patient samples. Therefore, there is no "test set" in the sense of a patient data set for an AI/diagnostic device.

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

Not applicable. As no clinical tests were required, experts to establish ground truth for a test set of patient data were not used. The ground truth for engineering tests would be established by physical measurements and adherence to engineering specifications and recognized consensus standards.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was used.

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 applicable. This device is a radiation therapy delivery system with a motion tracking and compensation feature, not a diagnostic AI device requiring human reader interpretation, nor an AI-assisted diagnostic tool. No MRMC study was mentioned or performed.

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

While the Motion Tracking and Compensation feature includes algorithms, the performance evaluation described as "verification and validation testing" would pertain to the proper functioning of these algorithms within the integrated system, and their impact on the overall system's ability to deliver radiation accurately despite motion. The submission relies on demonstrating that these new components adhere to established safety standards and maintain the device's original performance specifications, not necessarily on a "standalone" algorithmic performance study in isolation from the machine. The document states that the "Motion Tracking and Compensation Feature measures tumor location and motion... and predicts tumor location... [and] compensates for tumor motion by making real-time adjustments," implying that its performance is inherently tied to the system's function.

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

Given the nature of the device (radiation therapy delivery system) and the type of submission (substantial equivalence with waiver of clinical data), the "ground truth" for the device's performance would be:

Engineering specifications and design requirements: The device's ability to accurately track and compensate for motion according to predefined engineering tolerances.
Compliance with recognized consensus standards: The device passed tests against relevant IEC and other standards for radiation therapy equipment and medical electrical equipment (e.g., IEC 60601 series).
Comparison to predicate device's established performance: The analysis repeatedly states that the new features are "substantially equivalent" and do not introduce new safety or effectiveness concerns compared to the already cleared predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning model in the sense of needing a separate "training set" of patient data for a diagnostic task. The description of the tracking and compensation algorithms suggests they are deterministic or traditional control algorithms, rather than machine learning models requiring extensive training data.

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

Not applicable, as there is no mention of a training set as would be understood for an AI/ML model for diagnostic purposes.

Summary

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November 23, 2018

Accuray Incorporated % Keith Picker Senior Regulatory Affairs Specialist 1240 Deming Way MADISON WI 53717

Re: K182687

Trade/Device Name: Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: September 25, 2018 Received: September 26, 2018

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'Hara For

Robert A. 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) K182687

Device Name

Motion Tracking and Compensation Feature for the 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
1240 Deming Way
Madison, WI 53717
Phone: 608-824-3069
Fax: 608-830-3778
Contact:	Keith Picker
Date Prepared:	September 25, 2018

Device Identification

Device Name:	Motion Tracking and Compensation Feature for theRadixact Treatment Delivery System
Trade & Brand Names:	Motion Tracking and Compensation Feature for theRadixact Treatment Delivery System
Common Name:	Radiation Therapy System
Regulation Number:	21 CFR 892.5050
Regulation Name:	Medical charged-particle radiation therapy system
Regulatory Class:	Class II
Product Code:	IYE

Predicate Device

Radixact Treatment Delivery System (K161146)

Device Description

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Neither the Radixact Treatment Delivery System nor the Motion Tracking and Compensation Feature disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use.

Intended Use

The Motion Tracking and Compensation Feature is an option within the intended use of the Radixact Treatment Delivery System. 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, non-rotational, 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

The intended use and indications for use statements for the Motion Tracking and Compensation Feature (shown above) are the same as for the Radixact Treatment Delivery System (last cleared on K161146), except for the addition of the introductory sentence.

Technological Characteristics

The Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature has imaging and treatment capabilities equivalent to those of the predicate Radixact Treatment Delivery System. It also has a similar functionallyequivalent CT style gantry and patient couch.

The intended use and indications for use of the Motion Tracking and Compensation Feature fit within those of the predicate Radixact Treatment Delivery System. Additionally, the predicate and subject devices have substantially equivalent performance specifications and technological characteristics. Further, the Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature and the predicate device employ the same fundamental scientific principles and have substantially equivalent principles of operation. The main difference between the predicate and the subject device is the use of the motion tracking and compensation feature. Where there are technological differences between the subject and predicate devices, those differences do not raise different questions of safety or effectiveness.

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A substantial equivalence table comparing the similarities and differences between the Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature and the predicate device is presented below. The minor differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

DeviceCharacteristic	Predicate DeviceRadixact TreatmentDelivery System(K161146)	Subject DeviceRadixact Treatment DeliverySystem with Motion Trackingand Compensation Feature	Analysis
System Description
Intended Use	Omitted for brevity.Reference 510(k)Summary (Section 8of 510(k) submission)	Same as predicate	Identical
Indications for Use	Omitted for brevity.Reference 510(k)Summary (Section 8of 510(k) submission)	Same as predicate	Identical
SystemConfiguration	Stand-alone radiationdelivery system (doesnot include datamanagement systemor planning system)	Stand-alone radiation deliverysystem with kV imaging andmotion tracking andcompensation added (does notinclude data managementsystem or planning system)	Substantiallyequivalent. Theintroduction of theMotion Tracking andCompensation Featuredoes not raise differentissues of safety oreffectiveness.
Vault (Treatment Room)
Minimum RoomDimensions(HWL)	274 x 462 x 602 cm	274.3 x 463 x 602 cm	Substantiallyequivalent. Minordifferences arenegligible.
DeviceDimensions(gantry and couch)(HWL)	255 x 280 x 473 cm	255 x 280 x 470.5 cm	Substantiallyequivalent. Minordifferences arenegligible.
Device Mass (kg)	6580 kg	6580 kg plus 235 kg for kVsubsystem components	The weight added dueto the kV subsystemdoes not result indifferent questions ofsafety or effectiveness
DeviceCharacteristic	Predicate DeviceRadixact TreatmentDelivery System(K161146)	Subject DeviceRadixact Treatment DeliverySystem with Motion Trackingand Compensation Feature	Analysis
Line Voltage	380 - 480 V ac3-Phase	Same as predicate	Identical
Ambient RoomTemperature	20 – 24 °C	Same as predicate	Identical
Relative Humidity(non-condensing)	30 – 60 %	Same as predicate	Identical
Gantry Mechanical Features
Bore Diameter	85 cm	Same as predicate	Identical
Degrees ofRotation	Continuous rotationaround Y- axis (axesper IEC 61217)	Same as predicate	Identical
Direction ofRotation	Clockwise (as viewedfrom the foot of thecouch)	Same as predicate	Identical
Rotational Speed(Treatment)	1 – 5 RPM	Same as predicate	Identical
Rotational Speed(Imaging)	10 RPM	Same as predicate	Identical
Couch Support inBore	Provided	Same as predicate	Identical
Radiation Delivery Modes
Description	Helical, Direct	Same as predicate	Identical
Photon Beam
Accelerator Type	Standing wave	Same as predicate	Identical
RF Source	Magnetron	Same as predicate	Identical
Nominal Energy	6 MV	Same as predicate	Identical
Fixed Field Size	1.0 cm x 40 cm2.5 cm x 40 cm5.0 cm x 40 cm	Same as predicate	Identical
Dynamic FieldSize	1.0 – 2.5 cm x 40 cm1.0 - 5.0 cm x 40 cm	Same as predicate	Identical
Dose Rate	850 cGy/minstandard1000 cGy/minoptional	Same as predicate	Identical
Collimation
Description	Primary collimation,jaws and multi-leaf	Primary collimation, jaws andmulti-leaf collimator	Substantiallyequivalent. Jaws have
DeviceCharacteristic	Predicate DeviceRadixact TreatmentDelivery System(K161146)	Subject DeviceRadixact Treatment DeliverySystem with Motion Trackingand Compensation Feature	Analysis
	collimator		a new dynamicbehavior for motionmanaged plans. Jawswill continually beadjusted to repoint thebeam at the movingtarget (in IEC-Y)while maintaining thesame field size.
MVCT Imaging
Source	MegavoltageComputedTomography(MVCT)	Same as predicate	Identical
Field of View(MVCT)	39 cm diameter	Same as predicate	Identical
Dose per MVCTImage (typical)	0.5 - 3.0 cGy	Same as predicate	Identical
Slice Spacing(MVCT)	1, 2, 3, 4 and 6 mmreconstructionintervals	Same as predicate	Identical
Spatial Resolution(MVCT)	1.6 mm	Same as predicate	Identical
kV Imaging
Source	Feature not present	50-150 kV Radiography Class I(60601-2-28) X-ray tubeassembly	The kV Imagingsubsystem providestwo-dimensional low-
Field of View	Feature not present	20 cm x 20 cm	dose radiographic
Spatial Resolution(kV)	Feature not present	< 1 mm	images used forpatient alignment and
Approximate Doseper kV x-rayimage (range)	Feature not present	0.08 - 0.20 mGy	measurement of tumormotion duringtreatment delivery.
Small Focal SpotSize	Feature not present	0.6 mm x 0.6 mm	The functionality isprovided by hardwareand driver software. AkV radiograph can beperformed at anyarbitrary angle. Astable calibration from
Large Focus SpotSize	Feature not present	1.0 mm x 1.0 mm
Current Range(mA)	Feature not present	5 - 500 mA
DeviceCharacteristic	Predicate DeviceRadixact TreatmentDelivery System(K161146)	Subject DeviceRadixact Treatment DeliverySystem with Motion Trackingand Compensation Feature	Analysis
			the kV Imagingcoordinate system tothe machinecoordinate system ismade duringconfiguration of theTDS. The new kVimaging componentsmeet applicable safetyrequirements in theIEC 60601 series.
Motion Management
TrackingAlgorithm	Not present	Radixact Motion Tracking	Substantiallyequivalent. Theintroduction of theMotion Tracking andCompensation Featureis based on the coretracking algorithmintroduced inK120233, SynchronyRespiratory TrackingSystem.
CompensationAlgorithm	Not present	Radixact Motion Compensation	The compensationalgorithm uses thejaws and MLC toeffectively repoint thebeam to accommodatefor motion in a methodsubstantiallyequivalent toK120233, SynchronyRespiratory TrackingSystem.Does not result indifferent questions ofsafety or effectiveness.
Synchrony Camera	Not present	Radixact Synchrony MotionTracking	Substantiallyequivalent. TheSynchrony camera has
DeviceCharacteristic	Predicate DeviceRadixact TreatmentDelivery System(K161146)	Subject DeviceRadixact Treatment DeliverySystem with Motion Trackingand Compensation Feature	Analysis
Laser System			been in use for overten years and wasincluded most recentlyin K120233,SynchronyRespiratory TrackingSystem.
Stationary	Green lasers identifyvirtual and actualisocenter	Substantially equivalent	Minor differences arenegligible and do notresult in differentquestions of safety oreffectiveness.
Moveable(for patientpositioning andregistration)	Red lasers identifyoffset from virtualisocenter	Substantially equivalent	Minor differences arenegligible and do notresult in differentquestions of safety oreffectiveness.
Patient Couch
Motion	Independent of eachof the other axes	Independent of each of the otheraxes	Identical
Biocompatibility
Couch Top	Carbon-fiber top	Carbon-fiber top	Identical
Synchrony Vest	Not Used	Same vest cleared underK120233, SynchronyRespiratory Tracking System	No newbiocompatibilityissues
Power Distribution
Isolation	Transformer	Transformer	Substantiallyequivalent. Theintroduction of theMotion Tracking andCompensation Featuredid not introducechanges to thissubsystem.
UPS for DataBack-up	Provided	Provided	Substantiallyequivalent. Theintroduction of theMotion Tracking andCompensation Feature
DeviceCharacteristic	Predicate DeviceRadixact TreatmentDelivery System(K161146)	Subject DeviceRadixact Treatment DeliverySystem with Motion Trackingand Compensation Feature	Analysis
Operator Station (Treatment Delivery Console)			did not introducechanges to this design
	Description	User interface tosystem functions (i.e.,patient and procedureselection, andprocedure delivery)	User interface to systemfunctions (i.e., patient andprocedure selection, andprocedure delivery)

Machine Control Software
	Description	Controls radiationdelivery andpositioning systems(referred to as theECS – EmbeddedControls Subsystem)	Controls radiation delivery andpositioning systems (referred toas the ECS - EmbeddedControls Subsystem)
	Data InterfacesOperator Station	Providesmeasurements andstatus duringoperation	Provides measurements andstatus during operation
Database
	Description	External databaseused for gatheringoperational data andstorage of proceduredata	External database used forgathering operational data andstorage of procedure data

DeviceCharacteristic	Predicate DeviceRadixact TreatmentDelivery System(K161146)	Subject DeviceRadixact Treatment DeliverySystem with Motion Trackingand Compensation Feature	Analysis
Safety Features
InterlockSubsystems	Present	Present	Substantiallyequivalent. kVsubsystem integratedinto the SafetyInterlocks. Nodifferent issues ofsafety or effectiveness.
Data integritychecking	Present	Present	Substantiallyequivalent. Theintroduction of theMotion Tracking andCompensation Featuredoes not modify thisdesign.

Device Comparison Table: Radixact Treatment Delivery System with Motion Tracking and Compensation Feature

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Performance Data

The Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature was tested and shown to comply with the requirements of applicable FDA recognized consensus safety standards for radiation therapy equipment. Results of verification and validation testing confirm that the use of the Motion Tracking and Compensation Feature on the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users.

No animal or clinical tests were required to establish substantial equivalence with the predicate device. The performance data demonstrate that the Motion Tracking and Compensation Feature is compatible with the Radixact Treatment Delivery System, and the Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature is as safe and effective and performs as well as the predicate device. Further, these test results demonstrate that the Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature has substantially equivalent safety and performance characteristics in comparison to the predicate device.

Conclusion

The Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature is substantially equivalent to the predicate device. The intended use and indications for use of the Motion Tracking and Compensation Feature fit within those of the predicate Radixact Treatment Delivery System. Additionally, the major technological characteristics and the principles of operation of the Radixact Treatment

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Delivery System with the use of the Motion Tracking and Compensation Feature 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 with the use of the Motion Tracking and Compensation Feature in comparison to the predicate device. Further, the performance data demonstrate that the Motion Tracking and Compensation Feature is compatible with the Radixact Treatment Delivery System, and the Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature is as safe and effective and performs as well as the predicate device. Therefore, the Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature 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.