The CyberKnife and CyberKnife VSI Systems are intended to provide treatment planning and image-quided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated. The CyberKnife Systems may be used to treat astrocytoma, glioma, skull base tumors, metastases (brain and bony), nasopharyngeal carcinoma, meningioma, acoustic neuroma, schwannoma, pituitary adenoma, hemangioblastoma, craniopharngioma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, and tumors of the neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder. Patients should be examined by a team of physicians to determine if they are candidates for CyberKnife treatment.

Device Description

The CyberKnife Robotic Radiosurgery System and CyberKnife VSI Robotic Radiosurgery System are computer controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife and CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute.

AI/ML Overview

The provided 510(k) summary for the CyberKnife VSI™ Robotic Radiosurgery System primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance metrics.

Therefore, the requested information, particularly regarding specific numerical acceptance criteria, detailed device performance for those criteria, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is largely not present in this document.

However, I can extract the available relevant information and highlight what is missing based on your request.

Acceptance Criteria and Study for CyberKnife VSI™ Robotic Radiosurgery System

This device did not present a standalone study with explicit acceptance criteria and corresponding performance metrics in a table format in this 510(k) summary. Instead, it focused on demonstrating substantial equivalence to an existing predicate device (the CyberKnife System). The main acceptance criterion appears to be that the new tracking software performs equivalently to the predicate device's tracking systems.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
New tracking software performs as designed.	Demonstrated to perform as designed.
Tracking performance is equivalent to predicate CyberKnife tracking systems.	Proved to be equivalent to the predicate CyberKnife tracking systems.
Integrity of existing features is maintained after updates.	Regression testing verified integrity of existing features.

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

Sample Size: Not explicitly stated as a number. The document mentions "Archived images from CyberKnife patient lung treatments." This implies a set of patient data, but the quantity is not specified.
Data Provenance: Retrospective, as it involved "Archived images from CyberKnife patient lung treatments." The country of origin is not specified, but given the applicant's address in Sunnyvale, California, USA, and FDA submission, it's likely US-based data.

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

Not specified. The document does not describe a process for establishing ground truth via expert consensus for this specific equivalence testing. The "ground truth" for tracking performance would likely be derived from the inherent physical accuracy of the existing CyberKnife system's tracking mechanisms, which the new software was compared against.

4. Adjudication Method for the Test Set:

Not specified. This detail is not relevant given the nature of the equivalence testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not described. The submission focuses on the performance of the device's tracking software, not human reader performance with or without AI assistance.

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

Yes, in spirit. The testing described involves "tracking software" performance and "regression testing to verify integrity of existing features." This typically refers to the algorithm's direct performance based on inputs (archived images) without active human interpretation as part of the core evaluation. The system itself is "computer controlled."

7. The Type of Ground Truth Used:

Not explicitly defined in terms of expert consensus, pathology, or outcomes data for this specific testing. Given that it was "tracking performance" compared to a predicate, the ground truth would likely be established by the known, validated performance characteristics of the predicate CyberKnife system's tracking, which the new software aimed to match. This would involve internal validation metrics of positioning accuracy and dynamic targeting.

8. The Sample Size for the Training Set:

Not specified. The document does not mention details about a training set for the tracking software. It's possible the software relies on established algorithms or models that were trained elsewhere, or that the "new" software is an update or refinement rather than a completely new AI model requiring a distinct training phase.

9. How the Ground Truth for the Training Set was Established:

Not applicable / Not specified. As no training set details were provided, the method for establishing its ground truth is also not elaborated upon.

Summary of Missing Information:

The 510(k) summary focuses on demonstrating substantial equivalence, which often means showing that the device performs "as well as" or "equivalently to" an existing device, rather than providing absolute performance metrics against predefined acceptance criteria for a novel functionality. Consequently, much of the detailed study design information requested (e.g., number of experts, specific sample sizes for test/training sets, detailed ground truth establishment for novel algorithms) is not present in this type of submission when the primary claim is equivalence via regression testing and performance matching a predicate.

Summary

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 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) 789-4260

Contact Person

Anne Schlagenhaft

Date Prepared September 30, 2010

Device Name

Trade Names: CyberKnife VSI™ Robotic Radiosurgery System CyberKnife® Robotic Radiosurgery System Common Name: Radiosurgery/radiotherapy treatment planning and delivery system Classification Name: Medical charged particle radiotherapy device

Device Description

Intended Use

NOV 1 7 2010

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The CyberKnife Systems may be used to treat astrocytoma, glioma, skull base tumors, metastases (brain and bony), nasopharyngeal carcinoma, meningioma, acoustic neuroma, schwannoma, pituitary adenoma, hemangioblastoma, craniopharngioma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, and tumors of the neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder. Patients should be examined by a team of physicians to determine if they are candidates for CyberKnife treatment.

Substantial Equivalence

The CyberKnife and CyberKnife VSI Systems are substantially equivalent to the predicate CyberKnife System. The source energy, beam properties, design, materials and other physical properties are the same or equivalent to the predicate CyberKnife Testing included in the premarket notification demonstrated that the System. performance characteristics of the device are equivalent to the predicate CyberKnife System.

Testing was done to verify that the new tracking software, performs as designed, as well as regression testing to verify integrity of existing features. Archived images from CyberKnife patient lung treatments were used to test tracking performance which proved to be equivalent to the predicate CyberKnife tracking systems.

The intended use, principles of operation, technological characteristics and labeling are the same or equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the eagle. The text is arranged in a circular fashion around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.

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

Ms. Anne Schlagenhaft Senior Regulatory Affairs Associate Accuray Incorporated 1301 Chesapeake Terrace SUNNYVALE CA 94089

NOV 1 7 2010

Re: K102650

Trade/Device Name: CyberKnife® Robotic Radiosurgery System and CyberKnife VSI™ Robotic Radiosurgery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 13, 2010 Received: September 23, 2010

Dear Ms. Schlagenhaft:

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 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 Parts 801 and 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,

Signature

David G. Brown, Ph.D. Acting 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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Indications for Use

510(k) Number (if known): K102650 Device Name: CyberKnife® Robotic Radiosurgery System and CyberKnife VSI™ Robotic Radiosurgery System Indications For Use:

The CyberKnife® Robotic Radiosurgery System and CyberKnife VSI™ Robotic Radiosurgery System are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Radiological Devices

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K 5102650

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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.