(203 days)
To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS), cervico-thoracic spine (CTS), head and neck.
The CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy is a treatment planning, imaging, and treatment delivery system for image-guided stereotactic radiosurgery and precision radiotherapy. The treatment planning system provides 3-dimensional viewing of the patient anatomy with appropriate dose calculation of the target volume and surrounding tissue structures. The imaging system provides real-time, orthogonal x-ray images of the patient in the treatment position to verify treatment position and accuracy and provides information suitable for dynamically positioning and pointing a linear accelerator. The treatment delivery system consists of a linear accelerator which provides 6 MV x-rays. A six-access manipulator provides automated positioning and pointing of the linear accelerator. The treatment couch provides positioning of the patient.
The provided document is a 510(k) summary for the CyberKnife™ System, a medical device for stereotactic radiosurgery/radiotherapy. It focuses on the substantial equivalence to a predicate device and does not contain detailed information on acceptance criteria or a study proving that the device meets specific performance criteria.
Therefore, I cannot provide the requested information from the given text.
The document does not describe:
- A table of acceptance criteria and the reported device performance: The "Feature Comparison Chart" compares technological characteristics between the CyberKnife and a predicate device (Varian Clinac 600SR), but these are not presented as acceptance criteria for a new device's performance validation. For example, "Mechanical Isocenter Accuracy" is listed as "≥ 0.05 cm RMS for all treatment nodes" for the CyberKnife, which could be an acceptance criterion, but the context does not explicitly state it as such for a validation study. There is no accompanying "reported device performance" against such a criterion in the document.
- Sample size used for the test set and the data provenance: No information on any test set or data provenance is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on experts or ground truth establishment for a test set is provided.
- Adjudication method for the test set: No information on an adjudication method is provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No information on an MRMC study is provided.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The CyberKnife is a treatment delivery system, not an algorithm in the typical sense this question implies for AI/diagnostic devices. The document does not describe standalone performance testing for software components.
- The type of ground truth used: No information on the type of ground truth for any study is provided.
- The sample size for the training set: The document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.
- How the ground truth for the training set was established: Not applicable as there is no training set.
The document primarily focuses on establishing substantial equivalence in terms of technological characteristics and intended use compared to a predicate device, as required for 510(k) clearance by the FDA, rather than presenting a performance study with detailed acceptance criteria.
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JUL 14 1999
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A C C U R A Y
510(k) Summary of Safety and Effectiveness
| Establishment: | Accuray Incorporated570 Del Rey AvenueSunnyvale, CA 94086(408) 522-3740 |
|---|---|
| Contact: | Luanne TermeerRegulatory Affairs Manager |
| Summary Date: | 12/20/98 |
| Device Name: | The CyberKnife™ System for StereotacticRadiosurgery/Radiotherapy |
| Predicate Device: | Varian Clinac™ 600SR, K913174 |
| Device Description: | The CyberKnife® System for StereotacticRadiosurgery/Radiotherapy is a treatment planning, imaging, andtreatment delivery system for image-guided stereotacticradiosurgery and precision radiotherapy. The treatment planningsystem provides 3-dimensional viewing of the patient anatomywith appropriate dose calculation of the target volume andsurrounding tissue structures. The imaging system provides real-time, orthogonal x-ray images of the patient in the treatmentposition to verify treatment position and accuracy and providesinformation suitable for dynamically positioning and pointing alinear accelerator. The treatment delivery system consists of alinear accelerator which provides 6 MV x-rays. A six-accessmanipulator provides automated positioning and pointing of thelinear accelerator. The treatment couch provides positioning of thepatient. |
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Intended Use: The CyberKnife system is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS) and cervico-thoracic spine (CTS), head and neck.
Summary of Technological Characteristics:
See the Feature Comparison Chart on the following page.
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FEATURE COMPARISON CHART
| Feature | Varian Clinac 600SR –K913174 | Accuray CyberKnife®System For StereotacticRadiosurgery/Radiotherapy |
|---|---|---|
| Use | Provide x-radiation for use in stereotactic radiosurgery.Treatment Planning with X-Knife, K923522 | Provide treatment planning and image guided stereotactic radiosurgery and precision radiotherapy |
| Single dose and fractionatedtreatments | Yes | Yes |
| Microwave band | S | X |
| X-ray energy | 6MV (standing wave linac) | 6 MV (standing wave linac) |
| Dose rate | 800 cGy/min | 300 cGy/min |
| Microwave generator | High power magnetron | High power magnetron |
| Bending magnet | In-line | In-line |
| Isocenter floor height | 128 cm | 127 cm (nominal isocenter, system is not isocentric) |
| SAD | 100 cm | 80 cm |
| End of collimator to isocenter | 23 cm | 40 cm |
| Source/target positioning | Two-axis manipulator | Six-axis manipulator |
| Treatment table | Rotates patient about third axis | Stationary |
| Mechanical Isocenter Accuracy | $≥ 0.10$ cm radius circle | $≥ 0.05$ cm RMS for all treatment nodes |
| Dosimetry system reproducibilitywith position | $± 2%$ or 1 MU whichever isgreater at any fixed gantry angle | $± 3%$ or 3 MU which ever is greaterat any fixed treatment node |
| Beam collimation | Heavy metal secondarycollimators allow selection ofnarrow beams sizes 12.5 to 40mm (12 steps) | Heavy metal secondary collimatorsallow selection of narrow beamssizes 5 to 60 mm (12 steps) |
| Head restraint | BRW or GTC head ring | Laitenen Stereoadapter headframe,K881131Uniframe head immobilizationsystem, K933227 |
| Target location reference | Metal localization rods connectedto headframe | Patient's skull |
| Treatment Planning System(TPS) | Yes | Yes |
| TPS platform | HP715/75, 64MB/1GB | SGI 440, 128MB/2GB |
| Safety interlocks | Yes | Yes |
| Emergency stop | Yes | Yes |
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the caduceus. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 14 1999
Luanne Ng Requlatory Affairs Manager Accuray, Inc. 570 Del Rey Avenue Sunnyvale, CA 94086
Re: K984563
CyberKnife™ System for Trade Name: Steriotactic Radiosurgery/Radiotherapy Regulatory Class: II Product Code: 90-IWB and 90-MUJ Dated: April 15, 1999 Received: April 16, 1999
Dear Ms. Ng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(t) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a dassification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_K984563
Device Name The CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy
Indications For Use: To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS), cervico-thoracic spine (CTS), head and neck.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rat. G. Palla
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi
510(k) Number K984563
Prescription Use
Per 21 CFR 801.109
OR
Over-The Counter Use
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.