(120 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 8.1 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 machine learning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available in one platform.
The provided text is a 510(k) Summary for RayStation 8.1. It details the device's intended use, technological characteristics, and a comparison to its predicate device, RayStation 7.0. However, it does not contain acceptance criteria or a detailed study description with performance metrics, sample sizes, ground truth establishment, or expert qualifications for the new functionality mentioned (machine learning and segmentation).
The document mainly focuses on establishing substantial equivalence to the predicate device, RayStation 7.0, based on shared underlying software platform and quality system. It states that "The test specification of RayStation 8.1 is a further developed version of the test specification of RayStation 7.0. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 8.1 therefore support the substantial equivalence of the above RayStation versions."
Therefore, based only on the provided text, the specific details requested regarding acceptance criteria and a study proving their fulfillment are not available. The document asserts that RayStation 8.1 performs "as well as the predicate device" based on verification and validation against an updated version of the previous device's test and requirements specifications, but it does not provide the specifics of these tests or their results in a measurable format.
To answer your request, I will indicate that the information is not present in the provided text for each point.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not provided in the document.
- Reported Device Performance: Not provided in a quantifiable manner for specific acceptance criteria. The document states "The summary of the performed non-clinical tests shows that RayStation 8.1 is as safe and effective and performs as well as the predicate device," but no specific metrics are given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not provided in the document. The document primarily focuses on demonstrating substantial equivalence to a predicate device, not on MRMC studies for AI assistance. The mention of "machine learning and segmentation" is under new features, but no specific performance study for these is detailed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not provided in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided in the document.
8. The sample size for the training set
- Not provided in the document.
9. How the ground truth for the training set was established
- Not provided in the document.
§ 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.