(29 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 does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets such criteria. The document is a 510(k) summary for the "Eclipse Treatment Planning System," primarily focused on establishing substantial equivalence to a predicate device.
However, based on the general nature of a 510(k) application for a treatment planning system, we can infer some general "acceptance criteria" related to the accuracy and functionality of dose calculation algorithms. The "study" would typically involve validation testing against known standards or other clinically accepted systems.
Here's an attempt to answer your questions based on what can be inferred, with explicit notes where information is missing:
Acceptance Criteria and Device Performance Study for Eclipse Treatment Planning System (K091492)
Note: The provided document is a 510(k) summary and primarily focuses on establishing substantial equivalence, not on detailing a specific performance study with explicit acceptance criteria. Therefore, much of the requested information regarding detailed study design, sample sizes, expert qualifications, and specific performance metrics is not present in the given text. The information below is based on general expectations for such devices and what can be vaguely inferred.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Dose Calculation Accuracy: | (Not explicitly stated in the provided text.) |
| Accuracy within clinical tolerances for various modalities (photon, electron, proton, brachytherapy). | The device's "Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye," suggesting it meets performance requirements for this specific application. The overall system is described as providing "software tools for planning the treatment... to design and simulate radiation therapy treatments," implying its calculations are considered clinically acceptable. |
| Agreement with established dose calculation methods or physical measurements. | Its substantial equivalence to the predicate device (Eclipse Treatment Planning System, K073020) suggests its performance is comparable and meets existing standards. |
| Functionality & Workflow: | (Not explicitly stated, but implied by device description.) |
| Ability to plan treatments for external beam (photon, electron, proton) and internal (brachytherapy). | "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." |
| User interface and features facilitating treatment design and simulation. | Described as a "computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments." |
| Safety & Control: | (Not explicitly stated, but implied by 510(k) process.) |
| Adherence to software development lifecycle and risk management. | The 510(k) process itself requires manufacturers to demonstrate compliance with general controls, including good manufacturing practices and risk management. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the document.
- Data Provenance: Not specified. Any internal validation data would typically be generated in a controlled environment, but the originating country or whether it's retrospective/prospective is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For a treatment planning system, ground truth would typically involve physical dosimetry measurements (e.g., ionization chambers, film, phantom studies) or comparisons to highly validated gold-standard algorithms, rather than direct expert consensus on a "test set" in the way one might evaluate diagnostic image interpretation. If human experts were involved in verifying the output, they would likely be medical physicists or radiation oncologists with extensive experience in dosimetry and treatment planning.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of a TPS, "adjudication" in the traditional sense (e.g., 2+1 for image interpretation) is less applicable. Validation would likely involve objective comparisons of calculated dose distributions against measured doses or established benchmark calculations, with deviations assessed against predetermined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, the provided document does not mention an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI tools where human reader performance is a key factor. For a treatment planning system, the focus is on the accuracy of the dose calculations and planning tools themselves, rather than how human readers improve with AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: While not explicitly called "standalone performance," the validation of the dose calculation algorithms within the Eclipse TPS would inherently be a standalone evaluation of the algorithm's accuracy against physical measurements or benchmark data. The purpose of a TPS is to provide accurate calculations that a human then uses, so the core function of the algorithms operates "standalone" in generating a dose plan. However, the document does not detail this validation study.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not specified in the document. For a treatment planning system, ground truth typically involves:
- Physical Dosimetry Measurements: Using phantoms and dosimeters (e.g., ionization chambers, film, TLDs) to measure actual dose distributions under controlled conditions.
- Validated Reference Algorithms: Comparing the new algorithm's output to established, highly accurate dose calculation algorithms.
- Monte Carlo Simulations: Considered a gold standard for dose calculation due to its ability to model individual particle interactions.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable in the context of this device. The Eclipse Treatment Planning System is a deterministic software system based on physics principles and established dose calculation models (e.g., pencil beam, collapsed cone, Monte Carlo). It is not an AI/ML device that "learns" from a training set in the typical sense of pattern recognition or predictive analytics. Its algorithms are developed and refined based on physical models and experimental data, not trained on a "dataset."
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. As explained in point 8, the Eclipse TPS is not an AI/ML system that requires a training set with associated ground truth in the way a diagnostic AI would. The "ground truth" equivalent during its development and validation would be derived from fundamental physics principles, extensive experimental dosimetry data, and clinical experience.
§ 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.