(49 days)
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
The Varian Eclipse™ Treatment Planning System (Eclipse TPS) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computerbased software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation, (brachytherapy) treatments.
The provided text describes the Eclipse Treatment Planning System (Eclipse TPS) and compares its features to a predicate device. However, it does not contain a study or data proving the device meets specific acceptance criteria in the context of a clinical performance evaluation.
Instead, the document is a Premarket Notification 510(k) Summary for the Eclipse TPS, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This is a regulatory submission process, not a clinical study.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- No "Acceptance Criteria" as clinical performance metrics: The table presented in the document is a "Substantial Equivalence Comparison Chart" which outlines features and functionalities of the Eclipse TPS and compares them to its predicate device. These are design and functional specifications, not clinical acceptance criteria with performance targets (e.g., sensitivity, specificity, accuracy, or reader agreement).
- No "Study" in the sense of a clinical trial: The document does not describe any clinical study, experimental design, or results that evaluate the device's performance against clinical endpoints. The "study" mentioned here refers to the 510(k) submission process itself, which relies on demonstrating equivalence rather than proving de novo clinical performance.
Therefore, for aspects related to "acceptance criteria," "study," "sample size," "experts," "ground truth," "MRMC," and "standalone performance," the information is not available in the provided text.
Here's what can be extracted based on the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
As explained above, the provided document does not present clinical acceptance criteria with performance metrics. Instead, it provides a "Substantial Equivalence Comparison Chart" detailing functional specifications and comparing the proposed device (Eclipse TPS) to a predicate device (Eclipse Treatment Planning System, K091492).
| Feature/Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Eclipse TPS) |
|---|---|---|
| Indication for Use | See above | See above |
| General Usage | ||
| External beam PHOTON planning | yes | yes |
| External beam PHOTON inverse planning | yes | yes |
| External beam ELECTRON planning | yes | yes |
| External beam PROTON planning | yes | yes |
| External beam OCULAR PROTON planning | yes | yes |
| Internal BRACHYTHERAPY planning | yes | yes |
| Stereotactic Frame Localization | yes | yes |
| Supported External Beams & Accessories | ||
| Photon beams | yes | yes |
| Electron beams | yes | yes |
| Proton beams | yes | yes |
| Coplanar fields | yes | yes |
| Non-coplanar fields | yes | yes |
| Multi-leaf Collimators | yes | yes |
| Asymmetric collimators | yes | yes |
| Stereotactic Cone collimators | yes | yes |
| Arc fields | yes | yes |
| Poured Blocks | yes | yes |
| Compensators | yes | yes |
| Physical wedges | yes | yes |
| Dynamic wedges | yes | yes |
| Rotating treatment couch | yes | yes |
| Supported Brachytherapy Sources & Accessories | ||
| Plan for high dose rate afterloader | yes | yes |
| Manual low dose rate brachytherapy: | ||
| seeds, line sources, wire | yes | yes |
| Applicator library | yes | yes |
| Needle templates | yes | yes |
| Graphical User Interface | ||
| Multiple-instance application | yes | yes |
| Multiple-workspace layout | yes | yes |
| Graphical display/editing of field parameters | yes | yes |
| Beam's-Eye-View display | yes | yes |
| 3D patient image display | yes | yes |
| Model for human Eye | yes | yes |
| SRS Localization application | yes | yes |
| SRS Planning application | yes | yes |
| Biological Optimization application | yes | yes |
| Biological Evaluation application | yes | yes |
| 3D Conformal Optimization application | yes | yes |
| Image Processing | ||
| Orthogonal image displays (3) | yes | yes |
| Oblique image display | yes | yes |
| Edge enhancement filters | yes | yes |
| Image smoothing filters | yes | yes |
| CT/MR/PET Image Registration | yes | yes |
| Image blending utility | yes | yes |
| 4D image display (registration of time series of 3D images) | yes | yes |
| Digitally reconstructed radiographs | yes | yes |
| Enclosed Volume measurement | yes | yes |
| Stereotactic Frame Coordinate transformation | yes | yes |
| Image Segmentation | ||
| Geometrical shapes | yes | yes |
| Manual editing and manipulation tools | yes | yes |
| Automatic /semi-automatic tools | yes | yes |
| Automatic/semi-automatic on-demand and post-processing tools for individual organs/structures | yes | yes |
| Automatic on-demand and pre-processing tools for multiple organs/structures | yes | yes |
| 3D Automargin | yes | yes |
| Logical operators | yes | yes |
| Dose Calculation | ||
| Distributed Calculation Framework | yes | yes |
| Photon calculation | yes | yes |
| Energy Range (Photon) | 1 MV - 50 MV | 1 MV - 50 MV |
| CT-based volumetric calculation | yes | yes |
| Non-CT based IRREG calculation | yes | yes |
| Convolution method | yes | yes |
| Combined electron/photon scatter | yes | yes |
| Directional heterogeneity correction | yes | yes |
| Treatment head modeling | yes | yes |
| Photon Monitor Unit calculation | yes | yes |
| Beam Angle Optimization (GEOS) | yes | yes |
| Leaf Motion Sequencing | yes | yes |
| Dose Dynamic Arc planning | yes | yes |
| Cone Dose Calculation | yes | yes |
| Biological optimization | yes | yes |
| 3D Conformal Optimization | yes | yes |
| AcurosXB dose calculation algorithm | no | yes |
| Electron calculation | yes | yes |
| Energy Range (Electron) | 1 MeV - 50 MeV | 1 MeV - 50 MeV |
| Gaussian Pencil Beam Model | yes | yes |
| Electron Monte Carlo algorithm | yes | yes |
| Electron Monitor Unit calculation | yes | yes |
| Proton calculation | yes | yes |
| Energy Range (Proton) | 50 MeV - 300 MeV | 50 MeV - 300 MeV |
| Brachytherapy calculation | yes | yes |
| AAPM TG 43 compliant | yes | yes |
| Point Dose calculation | yes | yes |
| Optimization to point dose constraints | yes | yes |
| Geometric optimization | yes | yes |
| Acuros dose calculation algorithm | yes | yes |
| Eclipse Algorithm Application Programming Interface (EAAPI) | no | yes |
| Dose Evaluation | ||
| Dose color wash | 2D, 3D | 2D, 3D |
| Isodose levels | 2D, 3D | 2D, 3D |
| Isodose Surface | 3D | 3D |
| Reference point dose summary | yes | yes |
| Dose Volume Histogram plot | yes | yes |
| Plan summing tool | yes | yes |
| Plan comparison tools | yes | yes |
| Evaluation using biological models | yes | yes |
| Plan Output - Hardcopy | ||
| Graphics window screen dump | yes | yes |
| Patient administration data | yes | yes |
| Plan parameters | yes | yes |
| Geometrical displays of plan data | yes | yes |
| Dose distribution | yes | yes |
| DVH plot | yes | yes |
| BEV display | yes | yes |
| Patient orientation | yes | yes |
| User Configurable hardcopy layouts | yes | yes |
| Import/Export Interfaces | ||
| VARIS/Vision database integration | yes | yes |
| DICOM RT / 3.0 | yes | yes |
| Other image formats | yes | yes |
| Electromagnetic Digitizer | import | import |
| Film Scanner | import | import |
| Export field coordinates to Laser System | export | export |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable/not provided. This document doesn't describe a clinical test set or study.
- Data provenance: Not applicable/not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not provided.
4. Adjudication method for the test set:
- Not applicable/not provided.
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:
- No MRMC study was done/reported in this document. The device is a treatment planning system, not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/not provided as a standalone performance study. The document focuses on the functional equivalence of the entire system for treatment planning, which inherently involves human professional users.
7. The type of ground truth used:
- Not applicable/not provided in the context of a performance study. For regulatory purposes, the "ground truth" for substantial equivalence is the predicate device's established performance and specifications.
8. The sample size for the training set:
- Not applicable/not provided. This document is not describing a machine learning or AI algorithm development study that would involve a training set.
9. How the ground truth for the training set was established:
- Not applicable/not provided.
§ 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.