(113 days)
The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, 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 multi-metastases 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 Cranial SRS w/ Cones application as one RT Element provides planning and display for functional diseases (e.g. trigeminal neuralgia) or cranial lesion radiation treatment.
The RT QA application as one RT Element 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 RT Elements group consist of different applications, referred to as Elements, intended for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
The newest addition to the RT Elements group is the Cranial SRS w/ Cones element, which is a software application used for automatic radiation treatment planning for either functional areas (e.g. trigeminal neuralgia) or cranial lesions using conical collimators.
Cranial SRS w/ Cones offers features for plan calculation (selection of machine profile and clinical protocols, dose calculation, etc.), plan review (isodose lines, Conformity index, min and max doses review. etc.), as well as, saving and exporting plan options. It is a software only device, with no patient contact.
For the dose calculation optimization, the Circular Cone dose algorithm is used on different publications:
- · Rice, R. K., Hansen, J. L., Svensson, G. K., Siddon, R. L .; Measurements of dose distributions in small 6MV x-rays. Phys. Med. Biol. 32; 1987; 1087-1099
- · Luxton G, Jozsef G, Astrahan M A; Algorithm for dosimetry of multiarc linear-accelerator stereotactic radiosurgery. (1991) Med. Phys. 18 pp 1211 - 1221.
- · ]Hartmann G. H. (Editor) Quality Assurance Program on Stereotactic Radiosurgery: Report from a Quality Assurance Task Group. (1995) Published by Springer-Verlag, Berlin Heidelberg.
The provided text does not contain detailed acceptance criteria or a study that specifically proves the device meets those criteria with explicit numerical results. Instead, it discusses the software's verification and validation, and its substantial equivalence to a predicate device.
However, I can extract the relevant information and formulate a response based on the available text:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided FDA 510(k) summary for Brainlab AG's RT Elements, specifically focusing on the Cranial SRS w/ Cones application, indicates that "All test reports were finally rated as successful according to their acceptance criteria." While the specific numerical acceptance criteria themselves are not explicitly listed in detail, the document highlights the general performance characteristic of the Circular Cone dose algorithm used by the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter/Characteristic | Acceptance Criteria (Implied/General) | Reported Device Performance/Statement |
|---|---|---|
| Accuracy of Circular Cone Dose Algorithm | Accuracy within a specified tolerance for dose calculations. | "The accuracy (reproducibility of measured beam data) of the circular cone dose algorithm is within 1%/1mm." |
| Functionality (Design Specifications) | All design specifications are met. | "The verification was done according to verification plan to demonstrate that the design specifications are met." |
| Usability | Device is usable by medical professionals for radiation treatment planning. | "The validation was done according to clinical evaluation plan and included usability testing..." |
| Safety and Effectiveness | Device does not introduce new issues concerning safety and effectiveness compared to predicate. | "...Verification and validation activities ensured that the design specifications are met and that the subject device does not introduce new issues concerning safety and effectiveness." |
| Compatibility | Device is compatible with target systems/environments. | "The verification of the subject device has been carried out thoroughly both at the top-level including compatibility testing..." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size (e.g., number of patient cases) used for the software verification and validation testing. It refers to "dose measurements" and "usability testing," but not the quantity of cases.
The data provenance is not specified in terms of country of origin. The study appears to be a retrospective evaluation of the software's performance and functionality based on established algorithms and internal testing, rather than a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. It mentions that the device is to be used by "medical professionals who perform radiation treatment planning (medical physicists, radiation oncologists, dosimetrists, physicians, etc.)," implying these are the types of experts who would evaluate such a device. However, there is no detail on who established the "ground truth" for the internal testing.
4. Adjudication Method for the Test Set
The adjudication method used for the test set is not described in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. The submission indicates that "No clinical tests have been included in this pre-market submission." The focus is on the substantial equivalence based on technological characteristics and software validation.
6. Standalone Performance Study
A standalone performance evaluation was conducted in the form of software verification and validation testing. The accuracy of the underlying algorithm is stated: "The accuracy (reproducibility of measured beam data) of the circular cone dose algorithm is within 1%/1mm." The verification process confirmed that design specifications were met, and validation included usability testing and dose measurements.
7. Type of Ground Truth Used
Based on the description, the ground truth for the testing primarily involved measured beam data / physical phantom measurements for dose algorithm accuracy and design specifications for functionality. The document references publications on which the circular cone algorithm is based, implying a comparison against established physical principles and previous research. For usability, the ground truth would likely be established through user feedback against predefined usability criteria.
8. Sample Size for the Training Set
The document does not mention a specific training set or its sample size. This submission focuses on the validation of the software and its underlying algorithm, not on the development of a machine learning model that typically requires a separate training set. The circular cone dose algorithm is a deterministic physical model, not a data-driven machine learning algorithm that needs a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for a machine learning model, the establishment of ground truth for a training set is not applicable in this context. The core dose calculation algorithm's accuracy is based on established physics and previous research outlined in the referenced publications.
§ 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.