(219 days)
The Target 2 V1.1 is a radiation oncology treatment planning system which uses CT and non-CT data to produce External Beam and Irregular Field plans, and non-CT data to provide Interstitial/Intracavitary Dosimetry plans.
The Target 2 V1.1 is an independent radiation oncology treatment planning system which uses CT and non-CT data to produce External Beam and Irregular Field plans, and non-CT data to provide Interstitial/Intracavitary Dosimetry plans. The system is interactive, using an optical mouse and defined display screen areas on the monitor, in conjunction with operating menus, to produce accurate planning routines. The treatment plan is contructed and displayed on the patient image. Plans can be stored on the system disk, output as hard copy and archived.
The provided document is a 510(k) premarket notification for a Radiation Treatment Planning (RTP) system, specifically the "Target 2 Version 1.1". It primarily focuses on demonstrating substantial equivalence to a predicate device (Target 2 Version 1.0) rather than presenting a detailed study with acceptance criteria, sample sizes, and expert adjudication for a novel AI-powered device.
Therefore, the document does not contain the information required to answer your request about acceptance criteria, a study proving the device meets them, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI device.
The document makes a high-level statement: "Test results indicate that Target 2 V1.1 performs its intended use and meets specifications in a safe and effective manner." However, it does not provide any specifics about these "test results" or "specifications" beyond stating its intended use is for planning radiation oncology treatments.
In summary, the information requested is not present in the provided text. This is a regulatory submission for a software update to a radiation treatment planning system, not a clinical validation study for an AI algorithm.
§ 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.