(78 days)
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.
The CyberKnife Robotic Radiosurgery System is a computer controlled medical system for planning and performing stereotactic radiosurgery and precision radiotherapy using a 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.
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary (K071531) for the CyberKnife® Robotic Radiosurgery System does not explicitly list specific acceptance criteria or quantitative performance metrics within the document itself. Instead, it states that the device is "substantially equivalent" to a predicate device, implying that its performance is implicitly accepted as meeting the same standards as the predicate.
The summary highlights the system's capabilities, which implicitly define its expected performance:
- 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."
- Key Technological Features for Performance: "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."
Therefore, based on the provided document, a table of explicit acceptance criteria and corresponding reported device performance cannot be generated. The acceptance is based on substantial equivalence to a predicate device, meaning its performance characteristics are presumed to be comparable.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information regarding a specific test set, its sample size, or its data provenance (e.g., country of origin, retrospective/prospective). This document focuses on the general description of the device and its intended use, and the declaration of substantial equivalence. Typically, detailed study information, including test set specifics, would be found in the full 510(k) submission, not necessarily in the publicly available summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided 510(k) summary does not mention any clinical studies involving expert observers to establish ground truth for a test set. As such, the number and qualifications of experts are not specified.
4. Adjudication Method for the Test Set
Since no specific test set or clinical study involving ground truth establishment by experts is detailed in the provided summary, there is no information about any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided 510(k) summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The CyberKnife system is a robotic radiosurgery system, not an AI-assisted diagnostic or interpretation tool for human readers in the traditional sense of MRMC studies. Its "AI" functionality, if any, would be embedded in its autonomous tracking and positioning capabilities.
6. Standalone Performance Study
The 510(k) summary does not detail a standalone performance study in terms of specific quantitative outcomes. The declaration of "substantial equivalence" implies that the device's standalone performance is comparable to an existing, legally marketed predicate device. The functional description of its tracking capabilities (skull tracking, fiducial tracking, Xsight™ Spine Tracking, Xsight™ Lung Tracking, and Synchrony™ Respiratory Tracking) highlights the system's autonomous operation to achieve precise radiation delivery.
7. Type of Ground Truth Used
The provided 510(k) summary does not specify the type of ground truth used for performance validation. Given that it is a radiosurgery system, the "ground truth" for its accuracy and efficacy would typically involve phantoms and/or clinical outcomes data, rather than expert consensus on diagnostic images or pathology. However, this level of detail is not present in the summary.
8. Sample Size for the Training Set
The provided 510(k) summary does not mention any training set or its sample size. The description indicates a mature, computer-controlled medical system, suggesting engineering and validation processes rather than a machine learning model that requires a "training set" in the common sense of AI development.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth was established.
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K07/531
510(k) SUMMARY
AUG 2 2 2007
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) 789-4260
Contact Person Anne Schlagenhaft
Date Prepared May 30, 2007
Device Name
Trade Name: CyberKnife® Robotic Radiosurgery System Classification Name: Medical charged particle radiotherapy device
Device Description
The CyberKnife Robotic Radiosurgery System is a computer controlled medical system for planning and performing stereotactic radiosurgery and precision radiotherapy using a 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.
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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. In the center of the seal is an abstract design that resembles an eagle or other bird-like figure. The design is composed of three curved lines that converge to form the shape of a bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 2 2007
Ms. Anne Schlagenhaft Senior Regulatory Affairs Associate Accuray Incorporated 1310 Chesapeake Terrace SUNNYVALE CA 94089
Re: K071531
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: IYE Dated: July 13, 2007 Received: July 16, 2007
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 (Premarket Approval), it may be subject to such 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.
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and Promoting Public
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.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). 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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 07/S3/
Device Name: CyberKnife® Robotic 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.
(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
(Optional Format 1-2-96)
Jshan
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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.