(24 days)
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 6.0 is a radiation therapy treatment planning system, i.e. a software program for planning and analysis of radiation therapy treatment plans. Functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation and 4D data compatibility, as well as unique features such as multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available on one platform.
This document is describing a 510(k) premarket notification for a medical device (RayStation 6.0), which aims to show substantial equivalence to a predicate device (RayStation 5.0). The provided text describes the software's functionality and its intended use but does not contain details about a study with acceptance criteria and device performance data in the context of an AI/human reader comparative study or standalone algorithm evaluation.
The sections "5.11 Assessment of non-clinical performance data" and "5.12 Test conclusion" briefly state that "The test specification of RayStation 6.0 is a further developed version of the test specification of RayStation 5.0" and that "The successful verification and validation of RayStation 6.0 therefore support the substantial equivalence of the above RayStation versions." However, it does not provide any specific acceptance criteria or performance metrics.
Therefore, I cannot fulfill your request for the detailed table and study information based solely on the provided text. The document focuses on regulatory submission aspects (e.g., 510(k) summary, intended use, technological characteristics comparison to a predicate device) rather than clinical performance data with specific acceptance criteria.
To answer your request, I would need a document that presents:
- Specific quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds).
- The actual reported performance of the device against these criteria.
- Details about the study design (sample size, data provenance, ground truth establishment, reader studies if applicable).
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.