(57 days)
The Oncentra RT Viewer is intended to be used for review and evaluation of DICOM based patient data by qualified specialists. It is used to load and display data generated by different DICOM modalities including, but not limited to: RT Image, RT Structure Set, RT Plan, RT Dose, CT, CR, MR, and PET.
It provides the user with a wide range of tools to compile, compare, and manipulate views and images. It enables super-positioning of geometrically related DICOM data.
RT Viewer provides tools for analysis of single and summed plans, and for comparison of several alternative plans. All image series and all RT objects (Structure Set, Plans, RT Images and Dose) in the study can be displayed and explored.
RT Viewer is principally a read-only activity and produces no new data or modifications to the data for the study and the plan(s).
Single Plan Evaluation
- Display of plan dose in original, reconstructed planar and 3D images.
- Display of dose as a sequence of objects,
- Inspection and comparison of individual objects for a plan in a study.
- Display of DVH in individual and total mode to view contributions from total plan or individual beams.
- Display of DVH statistics.
Plan Comparison
- Side-by-side display of a plan for selected plans in a study, shown as a sequence of objects.
- Comparison of DVH and dose statistics for plans in a study.
Plan Summation
- Summation of dose distributions for plans and display of summed dose.
- Display of DVH in individual and total mode to view contributions from summed or individual plans.
The software runs on a Windows XP or VISTA platform.
The provided text is a 510(k) summary for the Nucletron Oncentra RT Viewer 1.0. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, specific studies conducted to prove device performance, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
Therefore, I cannot populate the table or answer the questions as requested based on the given input.
The document primarily focuses on establishing substantial equivalence to a predicate device (Oncentra MasterPlan 3.1) and obtaining clearance from the FDA for marketing, rather than detailing a specific performance study with acceptance criteria. The statement "$510(k) Summary of Safety and Effectiveness Information$" suggests that the primary method of demonstrating safety and effectiveness for this type of device (a viewer/display system) is through comparison to an already cleared predicate, rather than extensive new clinical efficacy studies.
To address your request, I would need a different type of document, such as a validation study report or a more detailed technical file for the device, which would typically describe specific performance tests and their results against predefined acceptance 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.