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

Device Description

The CyberKnife Robotic Radiosurgery System is a computer controlled medical system 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 CyberKnife System uses skull tracking, fiducial tracking, Xsight™ Spine Tracking, Xsight" Lung Tracking, and Synchrony" Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.

AI/ML Overview

This 510(k) summary (K091146) from Accuray Incorporated for the CyberKnife® Robotic Radiosurgery System does not contain the detailed acceptance criteria and study information typically found in a clinical performance study. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a new clinical study.

Therefore, for almost all of your requested information, the answer is that the document does not provide this information.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Response: This information is not provided in the 510(k) summary. 510(k) submissions for substantial equivalence often rely on technical comparison and predicate device performance rather than new clinical trials with acceptance criteria.

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

Response: This information is not provided. No specific test set or data provenance from a study proving performance against acceptance criteria is mentioned.

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)

Response: This information is not provided. No test set requiring expert-established ground truth is described.

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

Response: This information is not provided. There is no mention of a test set or adjudication process.

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

Response: This information is not provided, and such a study would not typically be applicable to a robotic radiosurgery system like the CyberKnife, which is a treatment delivery device rather than an AI-assisted diagnostic tool for human readers.

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

Response: This information is not provided. The CyberKnife is a system performing treatment delivery, not a standalone algorithm in the sense of an AI diagnostic tool. Its performance is inherent to its mechanical and software precision.

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

Response: This information is not provided. If any "ground truth" were relevant, it would likely relate to the accuracy of radiation dose delivery and patient positioning, which are engineering and physics measurements, not typically clinical "ground truth" as you'd find in diagnostic imaging.

8. The sample size for the training set

Response: This information is not provided. As this is not a machine learning diagnostic device, the concept of a "training set" for an algorithm in this context is not directly applicable in the way it would be for an AI-driven image analysis tool. The CyberKnife uses advanced algorithms for tracking and radiation delivery, but these are typically developed through engineering and physics principles rather than statistical training on a large dataset of "cases."

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

Response: This information is not provided, as a training set in the typical AI sense is not described.

Summary of the CyberKnife System as per the 510(k) Summary:

Trade Name: CyberKnife® Robotic Radiosurgery System
Device Description: Computer-controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. It uses a linear accelerator, manipulator (robot), and a target locating subsystem (including skull tracking, fiducial tracking, Xsight™ Spine Tracking, Xsight™ Lung Tracking, and Synchrony™ Respiratory Tracking) to accurately deliver radiation.
Intended Use: To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions, and conditions anywhere in the body when radiation treatment is indicated.
Substantial Equivalence: The document states the device is substantially equivalent to a predicate device, with the same or equivalent intended use, principles of operation, technological characteristics, and labeling. This implies that the safety and effectiveness are established by comparison to an already cleared device, rather than through a new, detailed clinical performance study with acceptance criteria.

Summary

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510(k) SUMMARY

K091146

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

MAY - 1 2009

Accuray Incorporated 1310 Chesapeake Terrace Sunnyvale, California 94089 Ph. (408) 716-4600 Fax: (408) 789-4264

Contact Person

Anne Schlagenhaft

Date Prepared April 15, 2009

Device Name

Trade Name: CyberKnife® Robotic Radiosurgery System Classification Name: Medical charged particle radiotherapy device

Device Description

Intended Use

The CyberKnife Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.

Substantial Equivalence

The CyberKnife Robotic Radiosurgery System is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same or equivalent.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAY - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

Ms. Anne Schlagenhaft Senior Regulatory Affairs Associate Accuray, Inc. 1310 Chesapeake Terrace SUNNYVALE CA 94089

Re: K091146

Trade/Device Name: CyberKnife® Robotic Radiosurgery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 17, 2009 Received: April 20, 2009

Dear Dr. Reiss.

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 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 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.

(240) 276-0115 21 CFR 876.xxx (Gastroenterology/Renal/Urology) 21 CFR 884.xxx (Obstetrics/Gynecology) (240) 276-0115 21 CFR 892.xxx (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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr.

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,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Device Name: CyberKnife® Robot ic Radiosurgery System Indications For Use:

The CyberKnife® Robotic Radiosurgery System is 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)

tonul Whang
(Division Sign-Off)

Division of Reproductive, Abdomina Radiological Device 510(k) Number

Page 1 of

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.