(120 days)
The TrueBeam ™ system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
The TrueBeam™ Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device. The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
Here's an analysis of the provided text regarding the TrueBeam Radiotherapy Treatment System.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed performance study results that would typically include specific acceptance criteria and performance metrics for a novel AI/software device. Medical linear accelerators like the TrueBeam are complex systems with established engineering and physics-based performance standards, which are evaluated through extensive verification and validation (V&V) testing. The summary confirms that such testing was done, but doesn't elaborate on the specific acceptance criteria or quantitative results as one might expect for a diagnostic AI product.
Therefore, many of the requested fields regarding detailed study design (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies) are not present in this type of regulatory document for this kind of device. I will indicate where information is not available.
Acceptance Criteria and Device Performance for TrueBeam Radiotherapy Treatment System
| # | Information Requested | Details from Document |
|---|---|---|
| 1 | Table of Acceptance Criteria and Reported Device Performance | The document states: "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." However, specific quantitative acceptance criteria (e.g., "accuracy > 95%", "sensitivity > X") and corresponding reported device performance metrics are not detailed in this 510(k) summary. For a medical linear accelerator, acceptance criteria would typically involve precise measurements of radiation beam characteristics (e.g., dose output, flatness, symmetry), mechanical precision (e.g., gantry rotation accuracy, collimator alignment, couch positioning), safety interlocks, and software functionality. These are engineering and physics-based performance criteria rather than typical "AI performance metrics" (like AUC, sensitivity, specificity). |
| 2 | Sample Size for Test Set and Data Provenance | Not applicable/not provided. The "test set" concept, as typically applied to AI or diagnostic algorithms using patient data, does not directly apply here in the same way. The performance testing for a radiotherapy system involves physical measurements, simulations, and system-level validation, not typically a "test set" of patient cases with associated ground truth for a diagnostic output. |
| 3 | Number of Experts and Qualifications for Ground Truth | Not applicable/not provided. Ground truth for a radiotherapy device's performance would be established through physical dosimetry, imaging phantoms, and engineering specifications, often validated by medical physicists and engineers, rather than a panel of clinicians establishing "ground truth" on patient cases in an AI context. |
| 4 | Adjudication Method for Test Set | Not applicable/not provided. See point 2 and 3. |
| 5 | MRMC Comparative Effectiveness Study | No. This is a hardware/software system for radiation delivery, not a diagnostic AI tool that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device. |
| 6 | Standalone Performance Study (Algorithm Only) | The core functionality of a linear accelerator is inherently "standalone" in its physical operation, delivering radiation based on a treatment plan. The "summary of performance testing" implies a standalone evaluation of the TrueBeam system's components and integrated function against specifications. This is not an "algorithm-only" standalone performance in the sense of a pure AI diagnostic tool, but rather the integrated system's performance. The document states "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." This confirms standalone performance evaluation against defined requirements. |
| 7 | Type of Ground Truth Used | For the performance of a medical linear accelerator, ground truth would be based on: - Engineering Specifications: Design limits and required performance parameters. - Physical Measurements: Dosimetry data (e.g., ion chamber, film, diode measurements) for radiation output, field shape, and dose distribution in phantoms. - Imaging Phantoms: For kV imaging system accuracy (spatial resolution, contrast, artifact levels). - Safety Standards: Compliance with electrical, mechanical, and radiation safety codes. The document does not explicitly detail these, but they are standard for such devices. |
| 8 | Sample Size for Training Set | Not applicable/not provided. This device is a complex electromechanical system with integrated software, not an AI model trained on a "training set" of data in the typical machine learning sense. Its functionality is based on deterministic engineering, physics principles, and validated control algorithms, not statistical learning from a large dataset. |
| 9 | How Ground Truth for Training Set Was Established | Not applicable/not provided. See point 8. |
Summary of Study:
The provided 510(k) summary for the TrueBeam Radiotherapy Treatment System describes a medical linear accelerator that integrates components of a previously cleared device (Trilogy Mx Radiotherapy System). The "study" proving the device meets acceptance criteria is the comprehensive verification and validation (V&V) testing performed by Varian Medical Systems. This testing is standard for medical devices and ensures that the device meets its design specifications, performs as intended, and adheres to safety requirements.
The document indicates that "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." This statement serves as the proof specified in the context of the 510(k) submission. However, it does not provide the granular details of those tests, the specific quantitative acceptance criteria, or the exact performance numbers that would be found in detailed engineering and testing reports.
The key changes from the predicate device involved:
- Expansion of energy used (4-25MV vs. 6-25MV).
- Addition of LaserGuard II.
- Addition of a supplemental capacitive collision detection system (kV CCDS) on the kV source for enhanced proximity detection.
The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing exhaustive clinical efficacy studies for a novel technology (which would typically require a PMA). The regulatory approval (K111106) confirms the FDA's agreement that the TrueBeam system is substantially equivalent to existing devices and can be marketed.
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Premarket Notification [510(k)] Summary TrueBeam Radiotherapy Treatment System
AUG 1 8 2011
The following information is provided following the format of 21 CFR 807.92.
| Submitter's Name: | Varian Medical Systems, Inc.3100 Hansen Way E-110Palo Alto, CA 94304 |
|---|---|
| Contact Name: Vy TranPhone: 650/424.5731Fax: 650/842.5040Date: June 2011 | |
| Proprietary Name: | TrueBeam™ |
| Classification Name: | Medical charged-particle radiation therapy system21 CFR 892.5050, Class IIProduct Code: 90 IYE |
| Common/Usual Name: | TrueBeam Radiotherapy Delivery System |
| Predicate Device: | Trilogy Mx Radiotherapy System and Accessories: K092871 |
| Device Description: | The TrueBeam™ Radiotherapy Delivery System is a medical linear acceleratorthat integrates the previously cleared Trilogy Radiotherapy system andassociated accessories into a single device. |
| The system consists of two major components, a photon, electron, anddiagnostic kV X-ray radiation beam-producing component that is installed in aradiation-shielded vault and a control console area located outside thetreatment room. | |
| Intended Use Statement | The TrueBeam ™ system is intended to provide stereotactic radiosurgery andprecision radiotherapy for lesions, tumors, and conditions anywhere in thebody where radiation treatment is indicated. |
| Indications for UseStatement | The TrueBeam ™ system is intended to provide stereotactic radiosurgery andprecision radiotherapy for lesions, tumors, and conditions anywhere in thebody where radiation treatment is indicated. |
Technological Characteristics: Significant changes to the predicate device are listed below.
| Feature | Cleared device | Device with change |
|---|---|---|
| Energy used | 6-25MV | 4-25MV |
| LaserGuard II | . No | Yes |
| Proximity detection | Touchguards present on kV source,kV detector, positioning units | Addition of supplemental capacitive collisiondetection system (kV CCDS) on kV source |
Summary of performance testing:
Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with three lines extending from its wing.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Vy H. Tran Vice President, Corporate Regulatory Affairs Varian Medical Systems, Inc. Corporate Headquarters 3100 Hansen Way PALO ALTO CA 94304-1038.
AUG 1 8 2011
Rc: K111106
Trade/Device Name: TrueBeam Radiotherapy Treatment System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 7, 2011 Received: July 8, 2011
Dear Ms. Tran:
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 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 (OS) 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,
Mary SPatel
Mary S. Pastel, Sc.D. 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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TrueBeam Radiotherapy Treatment System
Indications for Use
510(k) Number (if known): __ | | | | 06 ______________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
TrueBeam is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Patel
510K
Division of Rediological Devic Office of In Vitro Diagnostic Device Evaluation and Safety
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§ 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.