(15 days)
Oncentra GYN 1.0 is a software application intended for Brachytherapy Treatment Planning, for the treatment of cancer, ie. intercavitary, interstitial, intraluminal, involving radioactive sources.
Oncentra GYN is a "real time" treatment planning system for brachytherapy especially meant for the treatment of gynaecological cancers. Direct 3D imaging of the treatment area gives the physician the possibility to update the planning of the dwell positions of the radioactive source in the target volume of the patient. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, e.g. dose volume histograms, dose verification points and dose profiles. The software program provides the physician with anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The software is an adaptation of the software of the predicate device to make the software more suitable for the use with gynaecological cancers. The following features have been added for this: Support for applicators and needles (instead of only needles), 3D MRI, CT and ultra sound image import (instead of only ultra sound), Support of multiple target volumes (instead of only one), Optimisation algorithms more suitable for gynaecological treatments. The modified device is an accessory to a brachytherapy afterloader. The program consists of two modules: Treatment planning Software: Oncentra GYN, Database: Smoothbase. The software runs on a Windows XP platform on the same hardware as Swift 2.0.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance), or training set information for a specific device.
The document is a 510(k) summary for a medical device called "Oncentra GYN," which is a treatment planning system for brachytherapy. It describes the device, its intended use, and its substantial equivalence to a predicate device (SWIFT 2.0). However, it focuses on regulatory submission details and does not include clinical study data or performance metrics.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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.