(205 days)
Brachyvision 6.0 is designed to allow the dose distribution of an implant or applicator to be individually shaped for each patient. Brachy Vision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy, using either temporary or permanent implants of various radioisotopes.
Brachy Vison 6.0 may be used for any brachytherapy planning activity, but has been specifically optimized for use with remote afterloaders (especially the VariSource unit from Varian), and for use with 3D images such as may be obtained from CT or MRI, or Ultrasound images.
Brachy Vision is a computer based product used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of Brachytherapy. The system consists of a computer with graphics display, film scanner input, and plotter output. Patient data may be entered from network connection, via the film scanner, via the optional back lit digitizer, or via the keyboard. Source placement information may be added to the patient data and isodose distributions, which would result from those source placements, may be displayed, analyzed and plotted. For use with remote afterloader devices, source dwell times may be optimized to user selected criteria.
The provided text describes Brachyvision 6.0, a computer-based product for calculating and displaying brachytherapy treatment plans. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria.
Therefore, I cannot provide the requested information. The document focuses on:
- Product Description: What Brachyvision does (calculates and displays treatment plans, works with various inputs like film scanner, digitizer, keyboard, network).
- Intended Use: For individual dose distribution shaping in brachytherapy, prospective and confirmation dose calculations using temporary or permanent implants of various radioisotopes.
- Technological Characteristics: References a "Specifications/Features Comparison Chart" which is not provided in the input.
- Regulatory Information: 510(k) submission details, substantial equivalence to a predicate device (Nucletron Plato Brachytherapy), and general information about FDA regulations.
Without a specifications table, performance data, or details of a validation study within the provided text, I cannot answer questions regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement in a study.
§ 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.