(94 days)
Smart Segmentation - Knowledge Based Contouring provides a combined atlas and model based approach for automated and manual segmentation of structures including target volumes and organs at risk to support the radiation therapy treatment planning process.
Smart Segmentation - Knowledge Based Contouring is a software only product that provides a combined atlas and model based approach to automated segmentation of structures together with tools for manual contouring or editing of structures. A library of already contoured expert cases is provided which is searchable by anatomy, staging, or free text. Users also have the ability to add or modify expert cases to suit their clinical needs. Expert cases are registered to the target image and selected structures propagated. Smart Segmentation Knowledge Based Contouring supports inter and intra user consistency in contouring. This product also provides an anatomy atlas which gives examples of delineated organs for the whole upper body, as well as anatomy images and functional description for selectable structures. It is not used to simulate plans or calculate dose. The contouring information is exported to the treatment planning software device.
The provided submission K112778 for "Smart Segmentation - Knowledge Based Contouring" does not contain detailed information regarding acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment methods, or information on multi-reader multi-case studies or standalone performance.
The submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It describes the device's functionality and compares it feature-by-feature with existing approved devices.
Therefore, the specific information requested in the prompt cannot be extracted from the provided text. The document primarily acts as a 510(k) summary demonstrating similarities to existing technology rather than presenting a performance study with quantitative 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.