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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

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.

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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) (K050296) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based 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 is a 510(k) summary for the Varian Eclipse Treatment Planning System (Eclipse TPS). It does not contain the detailed study information required to fill out the requested table and answer the specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or comparative effectiveness studies.

The document primarily focuses on the regulatory aspects of the device, such as:

• Submitter's information
• Proprietary and common device names
• Classification and predicate devices
• Device description and indications for use
• FDA's substantial equivalence determination letter

Therefore, I cannot extract the information required for your request from this document. To answer your questions, I would need a different type of document, such as a clinical study report, a validation study, or a more detailed technical submission that includes performance data and methodology.

Ask a specific question about this device

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) (K050296) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based 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 document is a 510(k) premarket notification summary for the Eclipse Treatment Planning System (Eclipse TPS). This device is a software tool used by trained medical professionals to design and simulate radiation therapy treatments.

However, the 510(k) summary (K071873) and the FDA letter do not contain information about acceptance criteria, performance studies with specific metrics, sample sizes for testing or training, methods for establishing ground truth, or details about human reader studies (MRMC or standalone AI performance).

The document primarily focuses on establishing substantial equivalence to a predicate device (Eclipse Treatment Planning System, K050296) and outlining the general indications for use and classification. This type of regulatory submission for a software device generally relies on verification and validation activities to ensure the software performs as intended, but the detailed results of these activities are typically not included in the public 510(k) summary.

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, one would need access to the full 510(k) submission including the detailed validation documentation.

Ask a specific question about this device