(84 days)
Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments, i.e., to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, treatment plan definition, manipulation and scheduling.
The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, and plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments. Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments, i.e., to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, treatment plan definition, manipulation and scheduling.
The Vision device (K042956) has been modified to introduce a module called Offline Review. Off-line Review allows the authorized user to review treatment images and provide capabilities to do quantitative image matching in order to define patient setup corrections for subsequent treatments, such as, Port Image Review: 2D/3D kV image matching, match Field Edges Plot, match Structures, Related Images; Manual / Automatic anatomy match; Statistics/Trends visualization of match results; export of patient setup correction data and entry for patient setup corrections for subsequent patient positioning and comments to images.
The Vision device is based on the client-server architecture, and thus all Vision clients/workstations load data from and store data to the common database. The database server provides data storage for other software products developed by Varian Medical Systems, Inc. (e.g., Eclipse, Acuity, PortalVision, and VARiSVision).
This 510(k) submission (K052391) for Varian Medical Systems' Vision™ with Off-Line Review feature does not contain specific acceptance criteria, study details, or performance metrics. The document is primarily a premarket notification summary, focusing on demonstrating substantial equivalence to a predicate device (Vision™, K042956) based on technological characteristics and intended use.
Therefore, I cannot provide the requested information in a table or as detailed responses to each point, as the input document does not contain this level of detail regarding performance studies.
However, based on the provided text, I can infer and state what is NOT present:
- No acceptance criteria or reported device performance metrics are explicitly stated. The document does not include a table outlining specific performance targets (e.g., accuracy, precision, speed for image matching) for the Off-Line Review feature, nor does it report any measured performance against such criteria.
- No detailed study is described that proves the device meets specific acceptance criteria. The submission focuses on substantial equivalence rather than a detailed performance study with defined endpoints and results.
- No information on sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details is provided. These elements are typically part of a comprehensive clinical or performance study, which is not detailed in this 510(k) summary.
Key points from the document pertinent to the request (though not directly answering them):
- Device Name: Vision™ (with Off-Line Review)
- Intended Use: "Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments, i.e., to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, treatment plan definition, manipulation and scheduling." The Off-Line Review module provides capabilities for "quantitative image matching in order to define patient setup corrections for subsequent treatments, such as, Port Image Review: 2D/3D kV image matching, match Field Edges Plot, match Structures, Related Images; Manual / Automatic anatomy match; Statistics/Trends visualization of match results; export of patient setup correction data and entry for patient setup corrections for subsequent patient positioning and comments to images."
- Predicate Device: Vision™, K042956
- Regulatory Focus: The 510(k) process primarily assesses substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical trials with detailed performance metrics and acceptance criteria for software modifications like this Off-Line Review feature.
In summary, the provided 510(k) application focuses on the functional description and intended use of the device and its new feature, along with asserting substantial equivalence to an existing predicate. It does not present the type of detailed performance study data that would include acceptance criteria and specific test results.
§ 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.