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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 7.0 is a radiation therapy treatment planning system, i.e. a software program for planning, management and analysis of radiation therapy treatment. 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 multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available in one platform.

This document is a 510(k) premarket notification for RayStation 7.0, a radiation therapy treatment planning system. It demonstrates the device's substantial equivalence to a legally marketed predicate device (RayStation 6.1). However, the document does not contain specific acceptance criteria, performance data, or details about a study proving the device meets these criteria in the manner typically associated with an AI/machine learning device submission.

The provided text focuses on:

• Regulatory information: FDA approval, classification, general controls, and compliance requirements.
• Device description: RayStation 7.0 as a software for radiation therapy planning, its workflow, and functionalities.
• Comparison to predicate device: Stating that the technological characteristics are the same, with improvements in usability, computational speed, and connectivity.
• Non-clinical performance data assessment: A general statement that the test specification of RayStation 7.0 is a "further developed version" of RayStation 6.1's, and successful verification and validation support substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the provided document does not contain this level of detail for RayStation 7.0.

The document implies that the device's performance is demonstrated through its successful verification and validation against an updated test specification derived from the predicate device. However, it does not detail:

• Specific quantitative acceptance criteria (e.g., accuracy, precision metrics).
• Reported device performance against those criteria.
• Sample sizes for test sets, data provenance, expert qualifications, or ground truth establishment methods as you would expect for typical AI/ML medical device submissions.
• MRMC studies or standalone AI performance.

It's important to note that RayStation 7.0, classified as a "Medical charged-particle radiation therapy system," is primarily a treatment planning software and not explicitly presented as an AI/ML diagnostic or predictive device in this document. The "improvements" mentioned are general software enhancements rather than specific algorithmic improvements subject to the rigorous validation studies you've outlined in your request.

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