(68 days)
VSim is a software solution to prepare anatomical data (CT) for the planning of external beam radiation therapy treatment.
VSim provides features to define anatomical regions, reference points and geometric treatment plans prior to dosimetric planning with a treatment planning system.
Virtual simulation, the most basic form of planning, allows more accurate placement of radiation beams than is possible using conventional X-ray imaging, where soft-tissue structures are often difficult to assess and normal tissues difficult to protect. The virtual simulation application syngo VSim allows the use of contouring and segmentation tools to assist in the drawing of the borders of the treatment volume and organ at risk.
syngo VSim is a software application that runs on a syngo® based workspace. It is a 3D-post-processing software application that uses CT planning images as input and creates as output DICOM-RT Structures and DICOM RT Plans for treatment planning.
syngo VSim is used to create 3D-models of target volumes and organs at risk. The main functionalities of syngo VSim are segmentation of organs, management of reference points and placement of geometrical treatment beams.
I am sorry, but the provided text does not contain the specific details about acceptance criteria, device performance, and study information that you requested. The document is a 510(k) premarket notification for a software device, syngo VSim, and primarily focuses on establishing substantial equivalence to a predicate device.
The document discusses:
- Intended Use and Indications for Use: The software prepares anatomical data (CT) for external beam radiation therapy treatment planning, defining anatomical regions, reference points, and geometric treatment plans.
- Comparison to Predicate Device: It states that syngo VSim is substantially equivalent to syngo Dosimetrist Workspace v2.7 (K101119). The main difference noted is that syngo VSim is a standalone software, while the predicate was a component.
- Nonclinical Testing: Mentions that nonclinical tests (integration and functional) were conducted and supported by verification/validation testing, and that a risk analysis was completed. It also lists several recognized safety and performance standards the device is designed to fulfill.
- Software Verification and Validation: Indicates that documentation for a Moderate Level of Concern software was included and that performance tests were conducted to test its functionality.
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts and their qualifications used to establish ground truth for the test set.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
- Explicit statement about a standalone algorithm-only performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that "The testing results support that all the software specifications have met the acceptance criteria" and "The result of all conducted testing was found acceptable to support the claim of substantial equivalence," but it does not specify what those acceptance criteria were or what the specific numerical performance results were against those criteria.
§ 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.