(88 days)
BAT is intended for use in external beam Radiation Therapy (RT)/Radiosurgery (RS) to locate internal anatomy that moves relative to external or bony landmarks, so as to position that anatomy correctly for the delivery of conformal radiation.
BAT can be used for the positioning of all patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.
BAT permits its user to align the isocenter crosshairs, structure contours or calculated dose (the latter 2 imported from a treatment planning system) with perpendicular ultrasound images acquired at treatment time. The BAT system then guides couch motion to achieve the desired patient alignment with the treatment beam. Additional ultrasound images can be taken to confirm proper positioning.
The provided document K981424 does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details regarding the ground truth for training or test sets.
The document primarily focuses on the device's classification, intended use, and a summary of substantial equivalence to predicate devices, as required for a 510(k) submission in 1998. It states that "Performance standards for this type of device have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." Therefore, no specific acceptance criteria or associated studies are detailed within this summary.
§ 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.