(59 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 2.5 is a treatment planning system, i.e. a software program for planning and analysis of radiation therapy plans. Typically, a treatment plan is created by importing patient images obtained from a CT scanner, defining regions of interest either manually or semi-automatically, deciding on a treatment setup and objectives, optimizing the treatment parameters, comparing rival plans to find the best compromise, computing the clinical dose distribution, approving the plan and exporting it.
The provided text describes a 510(k) submission for RayStation 2.5, a radiation treatment planning system. However, it does not contain the specific details required to complete your request for acceptance criteria and a study proving device performance.
The document states that the testing performed for RayStation 2.5 is a "further developed version of the test specification of RayStation 1.0" and that "The test results verify the requirements for dose tracking and thereby support a determination of substantial equivalence." This is a general statement about verification and validation but does not provide specific acceptance criteria, performance metrics, or study details.
Below is a breakdown of why each section of your request cannot be fully addressed based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "The test results verify the requirements for dose tracking" and lists the functionality verified:
- computing dose on CBCT
- deforming a fraction dose to the planning image given an approved deformable registration
- comparing planned dose, delivered dose and accumulated dose on planned or fraction images
However, it does not provide specific numerical acceptance criteria (e.g., dose calculation accuracy within X%, deformable registration accuracy within Y mm) nor does it report the actual device performance against any such criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document. The text refers to "verification performed for dose tracking" but does not specify the sample size of the test data or its origin.
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)
This information is not present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided 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
This information is not present in the provided document. The device is a and treatment planning system and the study mentioned is focused on verifying the dose tracking functionality, not a comparative effectiveness study with human readers assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "verification performed for dose tracking" which implies testing the algorithm's performance for this specific function. However, details of the standalone performance (e.g., metrics, results) are not provided. The overall device is a software system for planning and analysis, where humans are always "in-the-loop" for review and approval.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document mentions "verifies the requirements for dose tracking" but does not specify the type of ground truth used for this verification. For dose tracking, this would typically involve phantom measurements or highly accurate validated simulation tools, but this is not explicitly stated.
8. The sample size for the training set
This information is not present in the provided document. The document describes a "verification" of the system's functionality, not training of a machine learning model.
9. How the ground truth for the training set was established
This information is not present in the provided document, as no training set is mentioned.
In summary, the provided 510(k) summary focuses on the substantial equivalence of RayStation 2.5 to its predicate devices, discussing its functionality and verification activities in general terms. It does not delve into the specific details of a performance study with acceptance criteria and results as requested.
§ 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.