(28 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 Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multimetastases radiation treatment planning.
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.
The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.
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 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 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. There are several applications defined as an RT Element.
The RT Elements are released as a system. Each RT Element is released as a separate subsystem including risk analysis, verification and usability as well as design input an review activities. The system can be seen as container and documents compatibility between the elements. In addition, validation activities of the RT Elements are documented in the system as well as service and user documents.
The provided text does not contain specific acceptance criteria, study data, sample sizes, or details about expert consensus, MRMC studies, or standalone algorithm performance for the RT Elements device. The document primarily describes the device's indications for use, regulatory classification, and general information about its underlying dose calculation algorithms and the reason for the special 510(k) submission (a new optimization algorithm in Multiple Brain Mets SRS 2.0).
Here's what can be extracted and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative metrics for performance (e.g., accuracy, sensitivity, specificity). The document mentions that the accuracy of both the pencil beam and Monte Carlo algorithms is tested according to IAEA-TECDOC-1540 to be "better than 3%." This is the closest to an acceptance criterion in terms of numerical performance.
- Reported Device Performance: The document states that "optimization results of the new algorithm is equivalent to the algorithm used in the predicate device." It also mentions that "All tests reports were rated as successful according to the acceptance criteria" during verification and validation. However, no specific performance metrics like those typically found in clinical studies (e.g., AUC, sensitivity, specificity, or specific error rates) are reported for the RT Elements as a whole or for its individual applications.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Dose calculation accuracy: better than 3% (according to IAEA-TECDOC-1540) | Achieved (implied by "All tests reports were rated as successful according to the acceptance criteria") |
| Optimization results: equivalent to predicate device | Achieved ("optimization results of the new algorithm is equivalent to the algorithm used in the predicate device.") |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document mentions that "clinical experts evaluated the clinical suitability of radiation therapy planning using the RT Elements workflows," but doesn't quantify how many or their specific qualifications for establishing ground truth on a test set.
- Qualifications of Experts: It generally states "medical professionals who perform radiation treatment planning (medical physicists, radiation oncologists, dosimetrists, physicians, etc.)" were typical users and involved in validation.
4. Adjudication method for the test set:
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not specified. The document focuses on the capabilities of the RT Elements applications for treatment planning, not on a direct comparison of human readers with and without AI assistance in a diagnostic or interpretive context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the algorithms for dose calculation (pencil beam and Monte Carlo) and the new optimization algorithm in Multiple Brain Mets SRS 2.0 were tested for their inherent accuracy and equivalence to the predicate device. However, it doesn't refer to a standalone clinical performance study in the way it might be for a diagnostic AI. The "optimization results...is equivalent" suggests a standalone comparison of the new algorithm's output to the previous one.
7. The type of ground truth used:
- For the dose calculation algorithms, the ground truth appears to be based on established physical models and experimental verification detailed in scientific publications (Mohan et al., Kawrakow et al., Fippel et al.) and confirmed against IAEA-TECDOC-1540 (which outlines criteria for verifying dose calculation algorithms).
- For the new optimization algorithm, the ground truth for establishing "equivalence to the predicate device" would have been the performance/output of the predicate device's algorithm.
- For the validation by clinical experts, the "clinical suitability" likely involved expert consensus on the treatment plans generated, but the specific type of "ground truth" (e.g., patient outcomes, pathology confirmation) is not detailed.
8. The sample size for the training set:
- Not specified. The document refers to the dose calculation algorithms being based on published research and the new optimization algorithm being "rewritten," implying model training or development, but no details on training set size.
9. How the ground truth for the training set was established:
- Not specified. Given the nature of radiation treatment planning software, "training" in the traditional machine learning sense might not apply to all components. The dose calculation algorithms are based on physics models, not trained on labeled datasets in the same way an image classification AI would be. For the "optimization algorithm," the ground truth for its development would be the desired optimal treatment plan parameters or outcomes, likely derived from clinical best practices and physics principles, but specific details are not provided.
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April 12, 2019
Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Olof-Palme-Str. 9 München, 81829 GERMANY
Re: K190664
Trade/Device Name: RT Elements Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: March 11, 2019 Received: March 15, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K190664
Device Name RT Elements
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 Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multimetastases radiation treatment planning.
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.
The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.
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 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.
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) |
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SPECIAL 510 (K) SUMMARY RT ELEMENTS
| Manufacturer: | Brainlab AGOlof-Palme-Str. 981829 MünchenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 5033 |
|---|---|
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 2/26/2019 |
| Device: | RT Elements |
| Trade name: | Dose Review, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA,Adaptive Hybrid Surgery Analysis |
| Common/Classification Name: | System, Planning, Radiation Therapy Treatment |
| Primarypredicate Device: | K170750 RT Elements 1.3 |
| Deviceclassificationname: | Medical charged-particle radiation therapy system |
| Regulatory Class: | Class II |
| RegulationNumber: | 21 CFR 892.5050 |
| Product Code: | MUJ |
| 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.The Dose Review application as one RT Element contains features for review ofisodose lines, review of DVHs, dose comparison and dose summation.The Multiple Brain Mets SRS application as one RT Element providesoptimized planning and display for cranial multi-metastases radiation treatmentplanning.The Adaptive Hybrid Surgery Analysis application as one RT Element |
| The Cranial SRS application as one RT Element provides optimized planningand display for cranial radiation treatment planning. | |
| The Spine SRS application as one RT Element provides optimized planning anddisplay for single spine metastases. | |
| RT QA is an accessory to the RT Elements and contains features for patientspecific quality assurance. | |
| Use RT QA to recalculate patient treatment plans on a phantom to verify that thepatient treatment plan fulfills the planning requirements. | |
| Devicedescription: | 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. There are several applicationsdefined as an RT Element.The RT Elements are released as a system. Each RT Element is released as a |
| separate subsystem including risk analysis, verification and usability as well asdesign input an review activities. The system can be seen as container anddocuments compatibility between the elements. In addition, validation activitiesof the RT Elements are documented in the system as well as service and userdocuments. | |
| Operator Profile: | Typical users of the RT Elements are medical professionals who performradiation treatment planning (medical physicists, radiation oncologists,dosimetrists, physicians, etc.). |
| PatientPopulation: | There are no demographic, regional or cultural limitations for patients. It is up tothe 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 Calculationalgorithms: | The Brainlab pencil beam dose algorithm is based on publications by Mohan etal (1985, 1986, and 1987). |
| • Mohan R, Chui C, Lidofsky L; Energy and angular distributions of photons from medicalaccelerators. (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 irreshaped 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 Carloalgorithm developed by Iwan Kawrakow and Matthias Fippel (Kawrakow et al1996, Fippel et al 1997, Fippel 1999, Fippel et al 1999, Kawrakow and Fippel2000, Fippel et al 2003, Fippel 2004). |
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.
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- · 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 fluel 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 Bioloj 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!
- Kawrakow I, Fippel M: Investigation of variance reduction techniques for Monte dose calculation using XVMC, Physics in Medicine and Biology 45 (2000) 2163
- · Kawrakow I, Fippel M, Friedrich K: 3D Electron Dose Calculation using a Voxel Carlo Algorithm (VMC), Medical Physics 23 (1996) 445-457.
The accuracy of both algorithms is tested according to IAEA-TECDOC-1540 to be better than 3%.
The pencil beam algorithm has limited accuracy for dose calculations near inhomoqeneous 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 affected by the general limitation that in some cases the Hounsfield-Unit values of the CT scan do not represent the real characteristics of a material (e.g. mass density and material composition). This may lead to inaccurate dose calculation for nonhuman tissue materials (e.g. implants).
| Reason for theSpecial 510(k)submission: | The RT Elements are cleared with K170750The 510(k) for the new RT Elements generation is triggered by the newoptimization algorithm implemented in Multiple Brain Mets SRS 2.0. Thealgorithm was rewritten in order to increase robustness and consider additionalobjectives. It was successfully verified and validated that optimization results ofthe new algorithm is equivalent to the algorithm used in the predicate device.Changes to the remaining RT Elements have been investigated and found to beuncritical and equivalent to the predicate device. The intended use did notchange. |
|---|---|
| Substantialequivalence: | The RT Elements have been verified and validated according to Brainlabprocedures for product design and development. The information provided byBrainlab in this Special 510(k) application supports the claim of substantialequivalence to the predicate device. |
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Verification/ validation summary:
Verification:
The verification of the existing and new features of the RT Elements has been carried out throughout both at the top level and on the underlying subsystem. 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 planning 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 RT Elements workflows.
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.
§ 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.