(86 days)
The MMS . TherpacPLUS B3DTUI is a software application for pre-operative planning and post-operative evaluation of permanent implant brachytherapy procedures for the treatment of prostate cancer. It assists physicians and medical physicists in pre-olanning the patient's implant procedure and evaluating the actual post-operative results of the procedure.
Hardware Platform and Operating System: The application runs on standard Intel PCs under Microsoft Windows® 32-bit operating systems.
The application is available on an OR-safe hardware platform. This hardware platform has electrical safety, emission control and cleaning provisions.
Peripherals and Accessories: The application interfaces with an electromagnetic digitizer, video capture cards, printers, film scanners, as well as DICOM and other image importer and data drives and external sources.
Software Features: The application supports image capture and importation from clinical imaging modalities sources, structure contouring and template registration, seed placement and dosimetry display for procedure planning and post-plan evaluation. Planning functions are supported by auto seed placement and dose optimization routines. The application supports post-procedure evaluation through automatic seed identification. Both planning and evaluation functions allow plans to be printed on reports, support visualization in 2D and 3D views. The applications has two user support modules - seed source specification and database manager.
The provided text describes a medical device, MMS-TherpacPLUS B3DTUI, a software application for prostate brachytherapy planning and evaluation. However, the document is a 510(k) summary for regulatory clearance and does not contain any information about acceptance criteria or a study proving that the device meets such criteria. It focuses on device description, intended use, and substantial equivalence to predicate devices, which is the basis for its FDA clearance.
Therefore, I cannot provide the requested information from the given text. The details about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies are not present within these documents.
§ 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.