(120 days)
RESTITU is intended for use in external beam Radiation Therapy (RT) / Radiosurgery (RS) to locate internal anatomy that moves relative to external or bony landmarks, so as to position that anatomy correctly for delivery of conformal radiation.
RESTITU™ can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.
The RESTITU system integrates medical diagnostic ultrasound systems, position sensing optical tracking systems, graphics workstations and other parts used to link these components together.
RESONANT's RESTITU is a 3D ultrasound-based image-guidance system that utilizes an ultrasound device, an optical camera tracking device and software platform to produce high quality data needed to perform accurate patient positioning and tumor localization.
RESTITU provides the capability to acquire high quality volumetric data before or after a treatment delivery fraction providing a strong set of data for treatment plan-delivery comparison studies. The RESTITU system can be integrated in any radiotherapy planning or treatment room for treatment verification. The RESTITU system resides in both the CT-Sim and LINAC rooms and can be fully integrated into a comprehensive data and image network.
In both the radiotherapy planning and treatment rooms, the RESTITU system is used to acquire 2D U/S image slices with the integrated ultrasound system, and to match each of these 2D slices with 3D position and orientation obtained from the optical tracking component. In addition, the system also accomplishes the following tasks:
- Enable users to segment anatomical structures from the 3D U/S volume data set;
- Calculate the position and shape of a segmented anatomical structure;
- Calculate the vector and magnitude of the displacement between two anatomical structures obtained from two 3D data sets acquired at different times;
- Enable users to contour anatomical structures from the 3-D ultrasound volume set or 2-D ultrasound image slices:
- Track position of treatment couch to verify patient position.
The provided text does not contain detailed acceptance criteria, a study proving device performance, or information about sample sizes for test/training sets, expert qualifications, or adjudication methods. The document is a 510(k) summary for the RESTITU™ system, which describes its intended use and comparison to predicate devices, but lacks the specific study details requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 based on the provided text.
§ 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.