(77 days)
Virtual simulation with VSS is intended to be used to prepare geometric and anatomical data relating to a proposed radiation therapy treatment prior to dosimetry planning on a treatment planning system. Complex 3D volumes and field geometries can be visualised for plan preparation.
When connected to a Nucletron Simulix radiation therapy simulator, the simulation of the planned treatment fields can be aided by automated set-up on the Simulix simulator. Adjustments made on the Simulix can be reviewed on the virtual simulation system screen. A direct comparison of the CT-based treatment plan with the actual set-up on the Simulix, prior to patient treatment, can be made to verify the geometric beam parameters and set-up conditions.
VSS virtual simulation described in this submission is a software package for the virtual simulation of radiation therapy plans. VSS is installed and runs on a PLATO radiation therapy treatment planning system workstation.
Nucletron's VSS provides the virtual simulation capabilities required to define anatomical volumes and geometric treatment beams for radiation therapy treatment simulation. The 3D patient model is based on CT images and is displayed in single or multiple image windows. Treatment beams are simulated using surface rendering and digitally reconstructed radiographs.
The system uses CT images either from a DICOM 3 compatible scanner or from the PLATO treatment planning system patient database. Previously defined anatomical structures and beams can be read from the PLATO patient database. All anatomical structures and beams can be stored in the PLATO patient database or sent to a DICOM RT compatible system.
When connected to a Nucletron Simulix radiation therapy simulator, VSS allows the planned beam parameters to be downloaded directly to the Simulator for automatic set-up. The user can initiate the real-time transfer of actual simulator position to update the field parameters on VSS. VSS can be used to display the live image intensifier image, viewed on the same screen as the beam's eye view and planar image(s). A direct comparison of the CT-based treatment plan with the actual set-up on the Simulix, prior to patient treatment, can be made to verify the geometric beam parameters and set-up conditions.
The provided text is a 510(k) summary for the Nucletron VSS (Virtual Simulation System), dated February 11, 1998. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific study with acceptance criteria and performance metrics in the way a clinical trial report would.
Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training) is not present in the provided document.
However, I can extract the relevant information that is available and indicate where information is missing.
Acceptance Criteria and Study for Nucletron VSS (Virtual Simulation System)
The provided document, a 510(k) Pre-Market Notification, aims to demonstrate substantial equivalence to legally marketed predicate devices for regulatory clearance. It does not present a formal clinical study with specific acceptance criteria and performance metrics in the manner typically seen for new diagnostic or therapeutic devices. Instead, the "acceptance criteria" here implicitly refer to the FDA's requirement for demonstrating substantial equivalence for design, intended use, and technological characteristics to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Predicate Devices | Nucletron VSS (Reported Performance) |
|---|---|---|
| Intended Use | Radiation therapy virtual simulation system for preparing geometric/anatomical data prior to dosimetry planning. | "Virtual simulation with VSS is intended to be used to prepare geometric and anatomical data relating to a proposed radiation therapy treatment prior to dosimetry planning on a treatment planning system. Complex 3D volumes and field geometries can be visualised for plan preparation." |
| When connected to a Nucletron Simulix, it aids automated set-up on the simulator, allows review of adjustments, and enables direct comparison of CT-based plan with actual set-up to verify geometric beam parameters. | ||
| Technological Characteristics | Allows use of CT images for anatomical volumes and simulation of treatment beams. | "The VSS is substantially equivalent to the predicate devices. It allows the use of CT images for the definition of anatomical volumes and the simulation treatment beams." |
| Uses CT images (DICOM 3 compatible or PLATO database). Displays 3D patient model, simulates treatment beams using surface rendering and digitally reconstructed radiographs. Stores anatomical structures and beams in PLATO database or sends to DICOM RT. Can download planned beam parameters to Simulix for automatic set-up, transfer real-time simulator position, and display live image intensifier image for comparison. | ||
| Safety and Effectiveness | Legally marketed and deemed safe and effective by prior FDA clearance for similar devices. | Assumed to be safe and effective due to substantial equivalence to predicate devices, subject to general controls provisions of the Act (annual registration, listing, GMP, labeling, prohibitions against misbranding and adulteration). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated. The document is a 510(k) summary, which focuses on substantial equivalence rather than a detailed clinical validation study with a specific test set. It describes the device's functionalities but does not report on how those functionalities were tested on a specific dataset or patient cohort.
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 applicable/Not stated. As there is no described test set or study validating performance against a ground truth, this information is not provided. The comparison is against predicate devices and general standards for similar technology.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not stated.
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
- No. This document describes a "Virtual Simulation System" for radiation therapy planning, not an AI-assisted diagnostic or assistive device that would typically involve an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not stated. While the VSS is a software package, the context of its use is "human-in-the-loop" for radiation therapy planning. The document does not describe a standalone performance evaluation in the context of comparing automated output to a gold standard without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not stated. There is no described study in this document that establishes a "ground truth" for evaluating the VSS's performance in the way clinical studies do. The ground for approval is substantial equivalence to existing devices.
8. The sample size for the training set
- Not applicable/Not stated. The document describes a software system for virtual simulation, not a machine learning or AI model that relies on a specific training set of data.
9. How the ground truth for the training set was established
- Not applicable/Not stated.
§ 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.