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The OptiRad software is to be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgement prior to use. The device provides output data in the form of displays and/or hardcopies to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.

The OptiRad 3D-radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). Input is user controlled. This treatment planning system does not provide direct or indirect control over any treatment delivery device or system in any form. The OptiRad software application is intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations that are to be submitted for independent clinical review and verification by a physicist or physician prior to use. The application provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist, dosimetrist, or radiation treatment planner.

The provided text is a 510(k) summary for the OptiRad 3D Radiation Therapy Treatment Planning System. It describes the device, its intended use, and its technological characteristics, along with the FDA's clearance letter. However, it does not contain any information regarding specific acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications that would be required to answer your request.

Therefore, I cannot provide the requested information. The document focuses on the regulatory aspects of device submission and clearance, rather than a detailed performance study.

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