(191 days)
Brachytherapy planning with PLATO Brachytherapy is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal (including bronchial) and surface applicator treatments, involving manual or remote afterloading radioactive sources. The software program provides the physician with anatomical and dosimetric information (i.e. radiographs, transverse slices, or 3D coordinates) to determine the positioning and loading of the radioactive sources prior to insertion. The software also provides the treatment time and dose distribution for the specified loading. From this information the patient can be treated with radioactive sources.
With remote afterloading brachytherapy treatment planning the PLATO Brachytherapy program exports the treatment data, i.e. treatment times to the remote afterloader. With manual brachytherapy treatment planning the program exports treatment data regarding insertion/removal time, total dose in permanent implantation and dose distributions for patient records. With both types of software the dose grid is exported and can be evaluated in conjunction with the Nucletron PLATO External Beam treatment planning software.
PLATO Brachytherapy as described in this submission is a software package designed for treatment planning of brachytherapy procedures. This software runs on a PLATO radiation therapy treatment planning system workstation.
Nucletron PLATO Brachytherapy software is capable of reconstructing the brachytherapy implant (i.e. radiographs, transverse slices, or 3D coordinates), defining the location of the radioactive sources within the implant, identifying a reference point, i.e. dose points, anatomical points. Once this data is entered the prescription dose is defined and the software program calculates treatment data, including dose distributions and treatment/implantation time.
The brachytherapy treatment planning session allows the physician to evaluate the implant prior to insertion of the radioactive sources in order to determine the most optimal dose distribution within the treatment volume. Once the physician approves the treatment plan the implant is loaded with radioactive sources manually or via the Nucletron remote afterloading equipment. The PLATO Brachytherapy software exports the treatment data to the Nucletron remote afterloading system via a floppy, program card or network. The PLATO Brachytherapy software does not control the treatment unit; it strictly exports treatment times and related information. The Nucletron remote afterloading system and the clinical staff verify this data input prior to treatment.
Nucletrons' PLATO Brachytherapy software includes remote afterloading radioactive source brachytherapy treatment planning and manual loaded radioactive source brachytherapy treatment planning. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution. i.e. dose volume histograms, dose verification points, dose profiles, etc.
The provided text is a 510(k) summary for the Nucletron PLATO Brachytherapy (BPS v. 14.0) software. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
Therefore, I cannot fulfill your request for that specific information based solely on the provided text.
The document indicates that the device is a "software package designed for treatment planning of brachytherapy procedures" and states it "calculates treatment data, including dose distributions and treatment/implantation time." Substantial equivalence is claimed based on combining the functionality of predicate devices into one user interface.
To address your request, information regarding a separate validation study, performance testing, or clinical trials would be required. This 510(k) summary primarily focuses on demonstrating equivalence for regulatory clearance, not detailed validation performance against specific 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.