(781 days)
The NOMOS Peacock Plan is a radiation treatment planning package designed to allow medical physicists, dosimetrists and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by Peacock are based upon treatment machine specific data and are intended to provide a quide to delivering exrernal beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
Indications: The indications for the NOMOS Peacock Plan are the same as those for the predicate devices with external beam radiation: Present a graphical display of the resultant dose distribution around a target which is based upon the size, shape and position of the radiation treatment fields.
The NOMOS Peacock Plan is a radiation treatment planning package designed to allow medical physicists, dosimetrists and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by Peacock are based upon treatment machine specific data and are intended to provide a quide to delivering exrernal beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
Peacock Plan has been designed to generate plans for the implementation of 3-D Conformal Radiation Therapy (3-D-CRT) in a manner similar to the predicate devices listed above (Small Systems Group: Prowess 2000, K884261/A/B; GE Target Series 2, K896353; University of Michigan/Scanditronix: Scandiplan K903403). The basis for 3-D-CRT and its implementation is the mirror image of computerized tomography (General Electric K841997, Siemens K910859/A). The Peacock Plan and CT both use variations on computer implementations of filtered backprojection algorithms. In CT, a spatially-uniform-radiation exposure is delivered to the patient and the spatially non-uniform attenuation of the exit beam is measured. Peacock Plan creates treatment simulations based upon user annotated CT information. This information describes the desired shape of the isodose distribution and location of the desired dose. Peacock Plan then defines the beam intensities and shapes to produce this desired dose distribution at the target site. With Peacock Plan, a multileaf collimator, partial-attenuation block or other beam-blocking mechanisms may be employed to generate a spatially, non uniform beam which, when directed at the tumor, will form a spatially- uniform dose around the target volume.
The current version of Peacock Plan is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.
The provided document is a summary of safety and effectiveness for the Peacock Plan, a radiation therapy treatment planning computer program. It focuses on establishing substantial equivalence to predicate devices and describes the device's intended use and functionality.
However, it does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it provide details on sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.
This document details a traditional medical device (software for radiation treatment planning) that relies on established algorithms and comparisons to predicate devices for its safety and effectiveness claims, rather than clinical studies with performance metrics, ground truth, and expert evaluation often associated with AI/ML-based devices.
Therefore, I cannot populate the requested table and answer the subsequent questions based on the provided text, as the information is not present.
§ 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.