(166 days)
ROCS ULTRASEED™ (Prostate Ultrasound-guided Brachytherapy Planning System) is intended to be used for the computation, display, evaluation and output documentation of radiation dose estimations for prostate ultrasound-guided brachytherapy to be submitted for independent clinical review and judgment. The goal of this system is to provide a tool that will provide consistent results using well documented algorithms. This system does not provide direct or indirect control over any treatment delivery device or system in any form. The device only provides output data in the form of displays, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan and for documenting the actual implant. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
ROCS Ultraseed is software that executes well known and documented algorithms to produce radiation dose estimations for prostate ultrasound-guided brachytherapy. All data is user controlled and is in a table look-up format. Information is presented graphically on CRT screens and in hardcopy reports. The software is designed to run on a PC platform utilizing the Microsoft® Windows® operating systems. All dates are four digit numbers so the system is able to handle the year 2000.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is primarily a 510(k) summary and an FDA clearance letter for the ROCS Ultraseed™ device, focusing on its intended use, technological characteristics, and substantial equivalence to a predicate device. It lacks the specifics requested regarding a study proving the device meets 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.