The Precision™ treatment planning system is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

Device Description

The Precision™ Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. It includes the planning system features of both the currently marketed predicate devices: CyberKnife MultiPlan Treatment Planning System (K150873) and the TomoTherapy Planning Station (K121934). Hence, the Precision Treatment Planning System is intended for treatment planning for multiple platforms:

· Accuray's robotic radiosurgery systems, including but not limited to the CyberKnife® Treatment Delivery System (last cleared K150873).
· Accuray's ring gantry systems, including but not limited to the Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System (last cleared K121934).

AI/ML Overview

The provided document is a 510(k) summary for the Accuray Precision™ Treatment Planning System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not explicitly state acceptance criteria or provide a detailed study report that proves the device meets specific performance criteria through quantitative metrics.

The document focuses on demonstrating substantial equivalence to existing predicate devices (CyberKnife MultiPlan Treatment Planning System (K150873) and TomoTherapy Planning Station (K121934)) rather than presenting a standalone performance study against pre-defined acceptance criteria.

Therefore, many of the requested details such as specific acceptance criteria thresholds, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, or MRMC study results are not available in the provided text.

Here's what can be extracted based on the information given, and where information is missing:

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

The document does not provide a table with explicit numerical acceptance criteria. Instead, it states:

Acceptance Criteria (Inferred from substantial equivalence claim)	Reported Device Performance (Summary)
Ability to create, save, review, and modify treatment plans with quality comparable to or higher than predicate devices.	"The performance test data for Precision Treatment Planning System demonstrates that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as currently produced by each of the individual predicate treatment planning systems."
Similar performance characteristics to predicate devices.	"Thus, Precision Treatment Planning System demonstrates similar performance characteristics to the predicate devices."

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "performance test data" but does not detail its composition.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The document states that "Plans must be reviewed and approved by qualified medical practitioners prior to delivery," implying expert review is part of the clinical workflow, but it doesn't detail their role in establishing ground truth for testing.

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

Not specified.

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 MRMC or comparative effectiveness study involving human readers with and without AI assistance is mentioned. The device is a "Treatment Planning System," not an AI-assisted diagnostic tool for human readers. Its primary output is a treatment plan (dose distribution and parameters), not a diagnostic interpretation.

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

The document implies that the system's performance was evaluated standalone in comparison to the predicate systems, without explicitly calling it an "algorithm only" study. It states, "The performance test data for Precision Treatment Planning System demonstrates that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as currently produced by each of the individual predicate treatment planning systems." The focus is on the system's ability to generate treatment plans.

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

Not explicitly stated. Given it's a treatment planning system, the "ground truth" for its performance would likely relate to the accuracy of dose calculations and the ability to generate plans that meet established clinical objectives and physics models, which are typically validated against physical measurements (phantoms) and clinical expert review. The document mentions "review and evaluation against the treatment prescription and established physics models."

8. The sample size for the training set

The document focuses on the performance of the system as a whole rather than a specific AI component that would require a separate training set. While the system may employ algorithms, the 510(k) summary doesn't detail distinct training sets for machine learning models. Therefore, this information is not provided.

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

As above, details regarding training sets and their ground truth establishment are not provided in this 510(k) summary.

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 % Shweta Kaushik, Ph.D., RAC Regulatory Affairs Specialist II 1310 Chesapeake Terrace SUNNYVALE CA 94089

Re: K161136

Trade/Device Name: Precision Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ, IYE Dated: June 7, 2016 Received: June 9, 2016

Dear Dr. Kaushik:

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 O'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)

K161136

Device Name Precision™ Treatment Planning 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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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Name, Address, Phone and Fax number of the Applicant

Accuray Incorporated 1310 Chesapeake Terrace Sunnyvale, California 94089 Ph: (408) 716-4600 Fax: (408) 789-4249

Contact Person Shweta Kaushik

Date Prepared April 21, 2016

Device Name

Device Name: Precision™ Treatment Planning System Common Name: Radiation therapy treatment planning system Marketed Trade or Model Name: Precision™ Treatment Planning System Regulatory Classification Name: Medical charged-particle radiation therapy system Regulatory Class: II Regulatory Product Code: MUJ Classification Panel: Radiology Regulation Number: CFR 892.5050

Device Description

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MultiPlan Treatment Planning System (K150873) and the TomoTherapy Planning Station (K121934). Hence, the Precision Treatment Planning System is intended for treatment planning for multiple platforms:

· Accuray's robotic radiosurgery systems, including but not limited to the CyberKnife® Treatment Delivery System (last cleared K150873).
· Accuray's ring gantry systems, including but not limited to the Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System (last cleared K121934).

Indications for Use

Intended Use

The Precision™ Treatment Planning System is intended to be used by physicians, medical physicists, and dosimetrists to generate radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment plans. Plans may be created with the Precision treatment planning system for delivery using Intensity Modulated Radiation Therapy (IMRT) or 3-D Conformal Radiation Therapy (3DCRT) techniques.

The users will be able to create a plan that satisfies established clinical objectives. For stereotactic radiosurgery, the plan will generally involve delivering a tumoricidal dose to target tissue, while minimizing dose to other tissues. For radiation therapy and

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stereotactic radiotherapy, the plan will generally involve delivering a damaging dose to diseased tissue at a level that allows healthy tissue in the target volume to recover, while also minimizing dose to tissue outside the target volume.

The treatment plan with dose distributions and complete delivered dose value along with the input data will be available through a user display or printed report for user review and evaluation against the treatment prescription and established physics models. The treatment plan will then be saved by the user, approved by the qualified medical practitioner, and subsequently delivered by the treatment delivery system.

Technological Characteristics

There is no significant difference between the subject and predicate devices in terms of fundamental scientific technology or principles of operation. During the design of subject device, some modifications or additions were made to the CyberKnife MultiPlan Treatment Planning System to either include the functionality of TomoTherapy Planning Station or to improve the existing functionality/ user interface. A brief summary of the technological characteristics of the subject device in comparison to those of the predicate devices is provided below:

DeviceCharacteristic	CyberKnifeMultiPlanTreatmentPlanning System(K150873)(PrimaryPredicate Device)	TomoTherapyPlanning Station(K121934)(Predicate Device)	Precision Treatment PlanningSystem(Subject Device)
AssociatedTreatmentDelivery System	Determinestreatment planningand dosedistribution for theCyberKnife System	Determinestreatment planningand dosedistribution for theTomoTherapySystem	Same as predicates as determinestreatment planning and dosedistribution for both CyberKnife andTomoTherapy Systems
Hardware	PC classworkstation	PC classworkstation	Same as predicates (PC classworkstation)
Image seriesused	DICOM imageseries (CT, MR,PET, etc.)	DICOM imageseries (CT)	Same as predicates (CT, MR,PET, etc.)
Image registration	Rigid imageregistration	N/A	Same as predicate with addedDeformable Fusion

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Precise, innovative tumor treatments™

DeviceCharacteristic	CyberknifeMultiPlanTreatmentPlanning System(K150873)(PrimaryPredicate Device)	TomoTherapyPlanning Station(K121934)(Predicate Device)	Precision Treatment PlanningSystem(Subject Device)
Autosegmentation(VOI contour tool)	Brain, Male Pelvis	N/A	Same as predicate with addedHead and NeckAutosegmentation tool
TreatmentMachine set-up	Default forCyberKnife System	Default forTomoTherapySystem	Same as predicates but withadded option to select treatmentdelivery system if multiplemachines are available
Plan Modes	N/A	IMRT, 3DCRT	Same as predicate with addedForward Planning mode
Optimization anddose calculationsubsystem	N/A	Separate GPUprocessinghardware	Same as predicate with GPUintegrated into the PC workstation

Performance

The performance test data for Precision Treatment Planning System demonstrates that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as currently produced by each of the individual predicate treatment planning systems. Thus, Precision Treatment Planning System demonstrates similar performance characteristics to the predicate devices.

Substantial Equivalence

The subject device, Precision Treatment Planning System is substantially equivalent to both predicate devices: CyberKnife MultiPlan Treatment Planning System and TomoTherapy Planning Station in intended use, technological characteristics and performance. The minor differences in technological characteristics raise no new questions of safety or efficacy and the performance data confirms that the Precision Treatment Planning System is as safe and effective as the predicate devices.

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.