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RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.

The system functionality can be configured based on user needs.

The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

RayStation 9.1/RayStation 9.2 are radiation therapy treatment planning systems, i.e. a software program for planning and analysis of radiation therapy. The functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation, 4D data compatibility and treatment console interfacing, as well as unique features such as machine learning planning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available in one platform.

The provided text primarily focuses on the FDA 510(k) clearance for RayStation 9.1/9.2, comparing it to a predicate device (RayStation 8.1). While it mentions "test specifications," "successful verification and validation," and "non-clinical tests," it does not contain the detailed information required to answer the questions about acceptance criteria, study design, sample sizes, expert involvement, or specific performance metrics related to a device's performance against acceptance criteria.

The document states:

• "The test specifications of RayStation 9.2 are further developed versions of the test specifications of RayStation 8.1."
• "The successful verification and validation of RayStation 9.2 therefore support the substantial equivalence of the above RayStation versions."
• "The summary of the performed non-clinical tests shows that RayStation 9.1/RayStation 9.2 are as safe and effective and performs as well as the predicate device."

These statements indicate that testing was performed to demonstrate substantial equivalence, but they do not provide the details of those tests. The document is about regulatory clearance based on substantial equivalence, not a clinical performance study with specific acceptance criteria and detailed results.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a description of a study specifically designed to prove the device meets acceptance criteria, including quantitative performance data.

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