(64 days)
AdvantageSim™ MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.
AdvantageSim™ MD is a CT/MR/PET oncology application used by clinicians (radiologist, radiation oncologist, medical oncologist, nuclear medicine physicians and trained healthcare professional) to assist treatment planning.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) Premarket Notification Submission Summary for "GE Healthcare AdvantageSim™ MD with CT Atlas-based Contouring and Re-planning Options." It describes the device, its intended use, and its classification, and notes that the software complies with voluntary standards and underwent quality assurance measures like risk analysis, design reviews, and various testing (integration, performance, safety).
Crucially, under "Summary of Clinical Tests," it explicitly states:
"The subject of this premarket submission, AdvantageSim MD with CT Atlas-based Contouring and Re-planning Options software did not require clinical studies to support substantial equivalence since the two new features have triggered this 510(k) notification, CT atlas-based contouring and CT based re-planning options are part of Mirada’s FDA cleared product."
This indicates that no new clinical study was conducted for this specific 510(k) submission to demonstrate performance against acceptance criteria. Instead, substantial equivalence was established by referencing features already part of an FDA-cleared predicate device (Mirada's product).
Therefore, I cannot provide the requested information from the given text as it explicitly states that clinical studies were not required and thus, no such study demonstrating device performance against acceptance criteria is detailed.
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.