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The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments 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 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 describes a 510(k) premarket notification for the "Eclipse Treatment Planning System." It focuses on the changes and verification/validation activities for a new version of the system compared to its predicate device. However, it does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance in the manner requested (i.e., specific numerical acceptance criteria and a corresponding reported performance metric).

Here's a breakdown of what information is available and what is missing, based on your request:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in a quantitative manner. The document mentions "System requirements created or affected by the changes can be traced to the test outcomes" and that the product "conformed to the defined user needs and intended uses." This implies that the acceptance criteria are adherence to system requirements and user needs, but specific numerical targets (e.g., accuracy +/- X%) are not provided.
• Reported Device Performance: Similarly, specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) with numerical values are not reported. The document states that the outcome was that "there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable" and that the device is "safe and effective and to perform at least as well as the predicate device."

Therefore, a table cannot be constructed with the level of detail requested.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified. The document mentions "Verification and Validation were performed for all the new features and regression testing was performed against the existing features of Eclipse." This implies testing on, presumably, various patient plans or scenarios, but the number of cases or patients (i.e., the sample size) is not given.
• Data Provenance: Not specified. There is no mention of the origin of the data used for testing (e.g., country) nor if it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

The text focuses on the technical verification of the software's functionality, rather than a clinical study involving human expert evaluation of its outputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method: Not specified. Given that the testing appears to be primarily technical verification against system requirements rather than clinical agreement studies, an adjudication method for ground truth would likely not be relevant or mentioned.

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:

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The document describes a software update for a treatment planning system, focusing on new dose calculation algorithms and planning tools, not an AI-assisted diagnostic or decision-support tool where human reader performance would be compared.
• Effect Size: Not applicable, as no MRMC study was reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Yes, in a sense. The non-clinical testing performed is fundamentally a "standalone" evaluation of the algorithm's functionality and accuracy against its defined technical requirements. The document states "Verification and Validation were performed for all the new features and regression testing was performed against the existing features of Eclipse." This includes testing the new dose calculation algorithms (Acuros PT, Acuros BV intermediate dose calculation) and planning tools. However, specific performance metrics (e.g., accuracy of a dose calculation compared to a gold standard physics measurement) are not quantified in the provided text.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth: For the dose calculation algorithms, the "ground truth" would typically involve highly accurate physical measurements or very high-fidelity Monte Carlo simulations. For other functionalities, it would be adherence to pre-defined system requirements and expected outputs. Pathology or outcomes data are not mentioned, as this is a treatment planning system, not a diagnostic device. The document implies compliance with "defined user needs and intended uses" and "system requirements."

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/not specified. The Eclipse Treatment Planning System is a deterministic software based on physical models (e.g., Monte Carlo dose calculation). It is not described as an AI or machine learning model that would typically require a "training set" in the conventional sense. The "training" in this context refers to the development and calibration of the physical models within the software.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable/not specified, for the same reasons as above. The system relies on physical principles and mathematical models, rather than learning from labeled data.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence by outlining technological changes and confirming that non-clinical testing verified the new features and ensured the device performs as safely and effectively as its predicate. It does not contain the detailed quantitative performance metrics or clinical study results that your questions are seeking.

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