(164 days)
The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
The "Dose Review" application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.
The "Multiple Brain Mets SRS" application as one RT Element provides optimized planning and display for cranial multimetastases radiation treatment planning.
The "Adaptive Hybrid Surgery Analysis" application as one RT Element simulates an automated tadiation treatment plan. The simulated plan is intented for treatment evaluation for example in tumor board meetings or operating rooms.
The "Cranial SRS" application as one RT Element provides optimized planning and display for cranial radiation treatment planning.
The "Spine SRS" application as one RT Element provides optimized planning and display for single spine metastases.
"RT QA" is an accessory to the RT Elements and contains features for patient specific quality assurance.
Use "RT QA" to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.
The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.
The Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning.
The Adaptive Hybrid Surgery Analysis application as one RT Element simulates an automated template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms.
The Cranial SRS application as one RT Element provides optimized planning and display for radiation treatment planning for single lesions in the cranium. Cranial SRS 1.0 provides single lesion planning using a Volumetric Modulated Arc Therapy (VMAT) optimization, thus allowing dose modulation with both the MLC leaf positions and the dose rate or gantry speed. It particularly offers planning for lesions in the brain which benefit from dose modulation like large tumors close to organs at risk with a complex geometry. These indications include, but are not limited to Vestibular Schwannomas, Pituitary Adenomas, Meningiomas and Gliomas. Cranial SRS 1.0 can also be used for treating vascular anomalies like arteriovenous malformations (AVMs).
The Spine SRS application as one RT Element provides optimized planning and display for single spine metastases.
RT QA is an accessory to the RT Elements and contains features for patient specific quality assurance.
Use RT QA to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.
The provided text is a 510(k) Summary for the Brainlab RT Elements device. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria and the detailed study results that prove the device meets these criteria in the format requested.
The document states:
- "All test reports were rated as successful according to the acceptance criteria."
- "The verification was done according to verification plans to demonstrate that the design specifications are met."
- "The validation was done according to the validation plans containing usability tests which ensure that workflows or user interface are suitable for radiotherapy treatment planning. Furthermore clinical experts evaluated the clinical suitability of radiation therapy planning using the Cranial SRS and Spine SRS workflows. The acceptance and deliverability of VMAT treatment plans was successfully validated."
This indicates that acceptance criteria and study data exist internally at Brainlab and were submitted to the FDA, but they are not detailed in this public summary. The summary focuses on comparing technological characteristics to predicate devices (K170355 Raystation 6, K142108 RT Elements, K103246 iPlan RT) to demonstrate substantial equivalence, rather than providing the performance metrics of a specific clinical study with granular acceptance criteria.
Therefore, I cannot populate the requested table and fully answer the questions as the specific details of the acceptance criteria and the study that proves them are not present in the provided text.
Here's a breakdown of what can be inferred or stated based on the text, and what cannot:
What Can Be Inferred/Stated:
- Study Type: The "Validation" section mentions "usability tests" and clinical experts evaluating "clinical suitability." This suggests a form of human-in-the-loop evaluation and verification that the software functions as intended for its radiotherapy planning purpose. It also mentions "acceptance and deliverability of VMAT treatment plans was successfully validated," implying a technical performance assessment for this specific planning type.
- Ground Truth (for calculation accuracy): For the dose calculation algorithms (Pencil Beam and Monte Carlo), it states: "The accuracy of both algorithms is tested according to IAEA-TECDOC-1540 to be better than 3%." This implies that a ground truth for dose calculation is established by the IAEA-TECDOC-1540 standard, which could involve physical measurements or highly accurate simulations.
- Experts: "Clinical experts evaluated the clinical suitability of radiation therapy planning." No number or specific qualifications are given.
- Data Provenance: Not specified, but generally, medical device validation data for such systems would involve imaging and treatment planning data, likely from various clinical cases.
- Training Set: Not mentioned, as this document describes a 510(k) for a radiation treatment planning system, not an AI/ML device that requires explicit training data. The "acceptance criteria" discussed here are more about the software's functional performance and suitability for its intended use, rather than a diagnostic AI model's precision/recall.
What Cannot Be Provided from the Text:
- A table of acceptance criteria and the reported device performance: This detailed information is not present.
- Sample sizes used for the test set: Not specified.
- Country of origin of data, retrospective/prospective: Not specified.
- Number of experts used: Not specified.
- Qualifications of experts: Only "clinical experts" is mentioned, no specific qualifications or years of experience.
- Adjudication method for the test set: Not specified.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not specified, nor is an effect size provided for human readers with/without AI assistance (as this is a planning system, not a diagnostic AI).
- If a standalone (algorithm only) performance was done: The document mentions "verification" and "validation" against design specifications and usability, but doesn't detail standalone performance for AI-like metrics. The dose calculation accuracy (better than 3% to IAEA-TECDOC-1540) is a standalone algorithm performance metric.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the overarching "validation": Beyond the dose calculation accuracy, the "ground truth" for clinical suitability would likely be expert judgment and successful plan generation/deliverability.
- The sample size for the training set: Not applicable/not provided as this is not an AI/ML training context.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The provided 510(k) Summary serves its purpose of establishing substantial equivalence for regulatory approval. It mentions that tests were conducted per acceptance criteria but does not disclose those criteria or the detailed results of those tests. To answer your question thoroughly, one would need access to the full "verification plans," "validation plans," and "test reports" referenced in the document, which are typically proprietary and submitted directly to the FDA.
Summary Table (based on available information):
| Feature/Metric Fills from Document | Acceptance Criteria (Not Detailed in Public Summary) | Reported Device Performance (Not Detailed in Public Summary) |
|---|---|---|
| Dose Calculation Accuracy | Better than 3% (According to IAEA-TECDOC-1540) | "tested... to be better than 3%" (Statement confirms criteria met, but no specific data points) |
| VMAT Treatment Plan Acceptance/Deliverability | Successfully validated (Criteria for "successful validation" are not public) | "successfully validated" (Statement confirms criteria met, but no specific data points) |
| Workflow/UI Suitability | User interface suitable for radiotherapy treatment planning; workflows suitable for radiotherapy treatment planning | "ensur[ed] that workflows or user interface are suitable for radiotherapy treatment planning" (Statement confirms criteria met, but no specific data points) |
| Clinical Suitability (Cranial SRS, Spine SRS) | Clinical suitability of radiation therapy planning | "clinical experts evaluated the clinical suitability" (Statement confirms criteria met, but no specific data points) |
Additional Information (from text):
- Sample size for test set: Not specified.
- Data provenance: Not specified.
- Number of experts used: Not specified (only "clinical experts").
- Qualifications of experts: Not specified.
- Adjudication method: Not specified.
- MRMC comparative effectiveness study: Not specified (not applicable for this type of device).
- Standalone performance: Dose calculation accuracy is a standalone algorithm performance metric.
- Type of ground truth: IAEA-TECDOC-1540 for dose calculation accuracy. Expert judgment for suitability/usability.
- Training set sample size: Not applicable.
- Training set ground truth: Not applicable.
{0}------------------------------------------------
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2017
Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Olof-Palme-Str.9 Munchen, 81829 GERMANY
Re: K170750
Trade/Device Name: RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: August 2, 2017 Received: August 7, 2017
Dear Mr. Schwiersch:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K170750
Device Name
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Indications for Use (Describe)
The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
The "Dose Review" application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.
The "Multiple Brain Mets SRS" application as one RT Element provides optimized planning and display for cranial multimetastases radiation treatment planning.
The "Adaptive Hybrid Surgery Analysis" application as one RT Element simulates an automated tadiation treatment plan. The simulated plan is intented for treatment evaluation for example in tumor board meetings or operating rooms.
The "Cranial SRS" application as one RT Element provides optimized planning and display for cranial radiation treatment planning.
The "Spine SRS" application as one RT Element provides optimized planning and display for single spine metastases.
"RT QA" is an accessory to the RT Elements and contains features for patient specific quality assurance.
Use "RT QA" to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR RT ELEMENTS
| Manufacturer: | Brainlab AGOlof-Palme-Str. 9 |
|---|---|
| 81829 MünchenGermany | |
| Phone: +49 89 99 15 68 0Fax: +49 89 99 15 68 5033 | |
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 7/7/2017 |
| Device: | RT Elements |
| Trade name: | Dose Review, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA |
| Common/Classification Name: | System, Planning, Radiation Therapy Treatment |
| Primarypredicate Device: | K170355 Raystation 6 |
| ReferenceDevices: | K142108 RT ElementsK103246 iPlan RT |
| Deviceclassificationname: | Medical charged-particle radiation therapy system |
| Regulatory Class: | Class II |
| RequlationNumber: | 21 CFR 892.5050 |
| Product Code: | MUJ |
| Intended use: | The RT Elements are applications for radiation treatment planning for use instereotactic, conformal, computer planned, Linac based radiation treatment ofcranial, head and neck and extracranial lesions. |
| Indications foruse: | The RT Elements are applications for radiation treatment planning for use instereotactic, conformal, computer planned, Linac based radiation treatment ofcranial, head and neck and extracranial lesions. |
{4}------------------------------------------------
The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.
The Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning.
The Adaptive Hybrid Surgery Analysis application as one RT Element simulates an automated template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms.
Content of this submission:
The Cranial SRS application as one RT Element provides optimized planning and display for cranial radiation treatment planning.
The Spine SRS application as one RT Element provides optimized planning and display for single spine metastases.
RT QA is an accessory to the RT Elements and contains features for patient specific quality assurance.
Use RT QA to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.
Device The Dose Review application as one RT Element contains features for review of description: isodose lines, review of DVHs, dose comparison and dose summation.
The Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning.
The Adaptive Hybrid Surgery Analysis application as one RT Element simulates an automated template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms.
The Cranial SRS application as one RT Element provides optimized planning and display for radiation treatment planning for single lesions in the cranium. Cranial SRS 1.0 provides single lesion planning using a Volumetric Modulated Arc Therapy (VMAT) optimization, thus allowing dose modulation with both the MLC leaf positions and the dose rate or gantry speed. It particularly offers planning for lesions in the brain which benefit from dose modulation like large tumors close to organs at risk with a complex geometry. These indications include, but are not limited to Vestibular Schwannomas, Pituitary Adenomas, Meningiomas and Gliomas. Cranial SRS 1.0 can also be used for treating vascular anomalies like arteriovenous malformations (AVMs).
{5}------------------------------------------------
The Spine SRS application as one RT Element provides optimized planning and display for single spine metastases.
RT QA is an accessory to the RT Elements and contains features for patient specific quality assurance.
Use RT QA to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements.
Operator Profile:
Typical users of the RT Elements are medical professionals who perform radiation treatment planning (medical physicists, radiation oncologists, dosimetrists, physicians, etc.).
Patient Population:
There are no demographic, regional or cultural limitations for patients. It is up to the user to decide if the system shall be used to assist a certain procedure
Conditions of use:
The system can be used in a hospital environment, in a clinical planning office.
Dose Calculation algorithms:
The Brainlab pencil beam dose algorithm is based on publications by Mohan et al (1985, 1986, and 1987).
- ූ Mohan R, Chui C, Lidofsky L; Energy and angular distributions of photons from medical accelerators. (1985) Med. Phys. 12 pp 592 - 597.
- Mohan R, Chui C, Lidofsky L; Differential pencil beam dose computation model for phot (1986) Med. Phys. 13 pp 64 - 73.
- · Mohan R, Chui C; Use of fast fourier transforms in calculating dose distributions for irre; shaped fields for three-dimensional treatment planning. (1987) Med. Phys. 14 pp 70 - 7
The Brainlab Monte Carlo algorithm is based on the X-ray Voxel Monte Carlo algorithm developed by Iwan Kawrakow and Matthias Fippel (Kawrakow et al 1996, Fippel et al 1997, Fippel 1999, Fippel et al 1999, Kawrakow and Fippel 2000. Fippel et al 2003. Fippel 2004).
- · Fippel M: Fast Monte Carlo dose calculation for photon beams based on the VMC algorithm, Medical Physics 26 (1999) 1466-1475.
- · Fippel M: Efficient particle transport simulation through beam modulating devices Carlo treatment planning, Medical Physics 31 (2004) 1235-1242.
- · Fippel M. Haryanto F. Dohm O. Nüsslin F. Kriesen S: A virtual photon energy fluer Monte Carlo dose calculation, Medical Physics 30 (2003) 301-311.
- · Fippel M, Kawrakow I, Friedrich K: Electron beam dose calculations with the VMC and the verification data of the NCI working group, Physics in Medicine and Biolo‹ 501-520.
- · Fippel M. Laub W. Huber B. Nüsslin F: Experimental investigation of a fast Monte beam dose calculation algorithm, Physics in Medicine and Biology 44 (1999) 303{
{6}------------------------------------------------
| · Kawrakow I, Fippel M: Investigation of variance reduction techniques for Montedose calculation using XVMC, Physics in Medicine and Biology 45 (2000) 2163· Kawrakow I, Fippel M, Friedrich K: 3D Electron Dose Calculation using a VoxelCarlo Algorithm (VMC), Medical Physics 23 (1996) 445-457. | |||||
|---|---|---|---|---|---|
| The accuracy of both algorithms is tested according to IAEA-TECDOC-1540 tobe better than 3%. | |||||
| The pencil beam algorithm has limited accuracy for dose calculations nearinhomogeneous areas such as lung or bone tissue or close to the tissue border(both within a range of a few centimeters). The Monte Carlo algorithm is affectedby the general limitation that in some cases the Hounsfield-Unit values of the CTscan do not represent the real characteristics of a material (e.g. mass densityand material composition). This may lead to inaccurate dose calculation for non-human tissue materials (e.g. implants). | |||||
| Substantialequivalence: | The RT Elements are the current RT planning software generation of Brainlab.New in the RT Elements are the following features:- Treatment planning using the VMAT optimization algorithm and- Optimized arc placementVMAT algorithm for dose planning:Following the decision making flowchart in appendix A of the guidelineEvaluating Substantial Equivalence in Premarket Notifications [510(k)] weevaluated the substantial equivalence in respect to the new feature VMATalgorithm for dose planning between the primary predicate Raystation 6(K170355). And the subject device of this submission. The primary predicate islegally marketed and the devices have the same intended use. The followingtable compares the technological characteristics of the two devices in respect ofthe VMAT algorithm for dose planning: | ||||
| Technological | Raystation 6 | RT Elements | |||
| characteristics | (K170355) | (K170750) | |||
| Optimization based on | Yes | Yes | |||
| constraints for organs at risk | |||||
| Direct optimization of MLC leaf | Yes | Yes | |||
| positions | |||||
| Direct optimization of dose rateDirect optimization of gantry | Yes | Yes | |||
| speed | Yes | Yes | |||
| Possibility to create single ormultiple-arc plans | Yes | Yes | |||
| Possibility to use constantdose rate | Yes | Yes | |||
| Fulfillment of all acceleratorconstraints | Yes | Yes |
{7}------------------------------------------------
| Final forward dose calculationfor the optimization result | Yes | Yes |
|---|---|---|
| Export of the optimizedtreatment plan via DICOM RT | Yes | Yes |
Optimized arc placement
The primary predicate Raystation 6 (K170355) offers the 3D-CRT optimization module, which is in all relevant parts comparable to the optimized arc placement included in RT Elements. The Raystation 3D-CRT optimization module offers a wide variety of optimization possibilities, while the optimization offered in the RT Elements is restricted to table angle optimization and gantry start and stop angle optimization.
Following the decision making flowchart in appendix A of the guideline Evaluating Substantial Equivalence in Premarket Notifications [510(k)] we evaluated the substantial equivalence in respect of the new feature optimized arc placement between the second predicate device Raystation 6 (K170355) and the subject device of this submission RT Elements (K170750). The predicate device K170355 is legally marketed (decision 1) and the devices have the same intended use (decision 2) The following table compares the technological characteristics of the two devices in respect of the optimized arc placement:
| Technological characteristics | Raystation 6(K170355) | RT Elements(K170750) |
|---|---|---|
| Optimization based on organs at risk | Yes | Yes |
| Optimization of table angles | Yes | Yes |
| Optimization of gantry angles | Yes | Yes |
| Final forward dose calculation for theoptimization result | Yes | Yes |
| Export of the optimized treatmentplan via DICOM RT | Yes | Yes |
- Conclusion: According to these tables all technological characteristics in respect of the VMAT algorithm for dose planning and optimized arc placement of the predicate device and the RT Elements are the same. Therefore these features are substantially equivalent.
{8}------------------------------------------------
| TechnologicalCharacteristics ofsubject devicecompared to referencedevices: | device featuresof referencedeviceiPlan RT(K103246) | device featuresof referencedeviceRT Elements(K142108) | Device featuresof subjectdevice | |
|---|---|---|---|---|
| Characteristics | ||||
| DICOM Viewing | Yes | Yes | Yes | |
| Photon beamplanning | Yes | Yes | Yes | |
| 3rd partyHardwaresupport | Yes | Yes | Yes | |
| User interfacecontrol withtouchscreen andmouse/keyboard | Yes | Yes | Yes | |
| DICOM Imageimport | Yes | Yes | Yes | |
| DICOMSegmentationimport | Yes | Yes | Yes | |
| DICOM RTRegistrationimport | Yes | Yes | Yes | |
| DICOM RTExport | Yes | Yes | Yes | |
| Loading andSaving | Yes | No | Yes | |
| 3D Viewing | Yes | Yes | Yes | |
| Treatmentworkflowsupport | Yes | Yes | Yes | |
| DoseCalculation withPencil Beam | Yes | Yes | Yes | |
| DoseCalculation withMonte Carlo | Yes | No | Yes | |
| QualityAssurancepossibilities | Yes | No | Yes | |
| User definedtreatmenttemplates | Yes | Yes | Yes |
{9}------------------------------------------------
| Verification/validationsummary: | Verification: |
|---|---|
| The verification of the existing and new features of the RT Elements hasbeen carried out throughout both at the top level and on the underlying |
been carried out throughout both at the top level and on the underlying subsystem. Planning through VMAT as well as quality assurance and saving and loading of treatment plans was successfully verified. The verification was done according to verification plans to demonstrate that the design specifications are met.
Validation:
The validation was done according to the validation plans containing usability tests which ensure that workflows or user interface are suitable for radiotherapy treatment planning. Furthermore clinical experts evaluated the clinical suitability of radiation therapy planning using the Cranial SRS and Spine SRS workflows. The acceptance and deliverability of VMAT treatment plans was successfully validated.
All tests reports were rated as successful according to the acceptance criteria. The validation was performed with software versions and units that are considered equivalent to the final version of the product, as warranted by 21 CFR 820.30(g) and which have the UI as planned for the release.
{10}------------------------------------------------
§ 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.