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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 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 does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, or ground truth establishment for a device. Instead, it describes a premarket notification for the "Eclipse 12 Treatment Planning System," focusing on its features, intended use, and substantial equivalence to a predicate device.

The document states that "Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements" and "Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel." However, it does not provide the specifics of these tests, such as:

• Quantitative acceptance criteria for performance metrics (e.g., accuracy thresholds, precision values).
• Specific study designs (e.g., retrospective, prospective).
• Sample sizes for test or training sets.
• Data provenance (country, type of data).
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance details.
• Type of ground truth used (e.g., pathology, outcomes).
• How ground truth was established for training data.

Without this specific information, it is not possible to complete the requested table or describe the study in detail. The document is a regulatory submission summary, not a technical report detailing the validation studies.

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