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

Device Description

The CyberKnife 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 sophisticated target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking and tracking of implanted fiducials for dynamic positioning and pointing of the linear accelerator.

AI/ML Overview

The provided text is a 510(k) summary from 2003 for the CyberKnife® System, along with the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance criteria, studies, or acceptance criteria in the modern sense of algorithm evaluation.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/algorithm-driven device cannot be found in this document. The CyberKnife System, as described in this 2003 submission, is a medical linear accelerator system for stereotactic radiosurgery/radiotherapy, which uses image guidance and a FAST algorithm for targeting. The submission does not detail the performance of the "FAST algorithm" in terms of diagnostic accuracy or clinical decision support, but rather focuses on the safety and effectiveness of the overall system for delivering radiation treatment.

Explanation for Missing Information:

This 510(k) submission predates the widespread use and specific FDA guidance for evaluating AI/ML-driven medical devices, especially those focused on diagnostic performance or AI-assisted interpretation. The document primarily focuses on the device's intended use, technological characteristics, and comparison to a predicate device as required for a 510(k) clearance in 2003.

Summary of what can be inferred from the provided text, despite not directly answering the query:

Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy
Intended Use: Treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Key Technology Mentioned: The CyberKnife System uses "skull tracking and tracking of implanted fiducials for dynamic positioning and pointing of the linear accelerator." It also mentions "The CyberKnife System with the FAST algorithm."
Regulatory Pathway: 510(k) premarket notification, indicating substantial equivalence to a predicate device. This pathway generally relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than requiring extensive clinical trials to establish new performance criteria.
Date of Submission/Clearance: July 29, 2003 (submission) / September 3, 2003 (clearance).

To answer the questions as requested, one would typically need a more recent regulatory submission or a detailed clinical study report specifically evaluating the "FAST algorithm" or similar components in a way that aligns with current AI/ML performance evaluation standards.

Summary

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SEP - 3 2003

032345

APPENDIX F. 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 570 Del Rey Avenue Sunnyvale, California 94085 Ph: (408) 522-3740 Fax: (408) 522-3749

Contact Person

Anne Schlagenhaft

Date Prepared

July 29, 2003

Device Name

Trade Name:CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Classification Name: Medical linear accelerator

Device Description

Intended Use

Substantial Equivalence

The CyberKnife System with the FAST algorithm is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2003

Ms. Anne Schlagenhaft Senior Regulatory Affairs Associate Accuray Incorporated 570 Del Rey Avenue SUNNYVALE CA 94085

Re: K032345

Received: August 4, 2003

Trade/Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle Radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: July 29, 2003

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 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); 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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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K_o32 345

CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy Device Name:

Indications For Use:

The CyberKnife 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR (Per 21 CFR 801.109) Over-The-Counter Use

David G. Sumn

510(k) Num

(Optional Format 1-2-96)

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.