(311 days)
The AcQPlan 5.0 is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan 5.0 is intended to be used to plan radiation therapy treatments on linear accelerators and other similar teletherapy devices with x-ray beams of energies from 4 to 50 MV, cobalt-60, and electron beams with energies from 4 to 50 MeV of the entire human anatomy. It allows the treatment planner to employ such techniques as asymmetrically collimated fields, irregular fields, multi-leaf collimators, non-coplanar fields, bolus, and fixed wedges. It allows the treatment planner to take heterogeneities into account (CT only) for photon beams using two versions of the Batho method or the Equivalent TAR (ETAR) method, and it uses a generalized Gaussian pencil beam model for electron beams. Using AcOPlan 5.0. the treatment planner can simultaneously visualize target and normal tissues and the computed 3-D dose distributions in great detail, on a real-time basis. The treatment planner develops treatment plans in a coordinate system accurately fixed to set-up marks on the patient made possible by volumetric 3-D image processing. Tools for managing competing and complementary plans are provided. Tools, based on DVH plots, are provided for comparing competing plans. High quality DRS and DCS (digitally reconstructed or composited simulation) images, with BEV and beam graphics superimposed, are generated to replace conventional simulator films. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
The AcQPlan 5.0 provides three-dimensional, external beam radiotherapy treatment planning (RTP) based on Philips Computed Tomography and Magnetic Resonance volume datasets. AcQPlan 5.0 is a fully integrated software package option to AcQSim virtual simulation software for dose calculation and evaluation. When used with the geometricplanning functionality of Philips AcQSim virtual simulation package, AcQPlan 5.0 users can simulate and plan a comprehensive course of radiotherapy in a single episode of patient care on a single workstation
The provided text does not contain detailed information about specific acceptance criteria, a standalone study to prove meeting those criteria, or a multi-reader multi-case (MRMC) comparative effectiveness study. The submission focuses on demonstrating substantial equivalence to a predicate device, AcQPlan (K974770), based on safety and effectiveness considerations rather than specific performance metrics against pre-defined acceptance criteria.
The information provided outlines:
- Device Description: AcQPlan 5.0 is a 3-D external beam radiotherapy treatment planning (RTP) system embedded in a volumetric image processing environment. It integrates with AcQSim virtual simulation software for dose calculation and evaluation.
- Intended Use: To plan radiation therapy treatments using various beam energies and techniques for the entire human anatomy. It allows visualization of target and normal tissues, 3-D dose distributions, and provides tools for plan management and comparison.
- Safety and Effectiveness Considerations: Safety is assured by adherence to FDA GMPs, IEC 60601-1, UL 187, and 21 CFR Subchapter "J" Performance Standards. Software safety is managed through Philips' LCM Procedures. Effectiveness is established by Philips's evaluation demonstrating performance according to development specifications.
- Substantial Equivalence Statement: The device is considered substantially equivalent to the predicate device, AcQPlan (K974770), and represents current state-of-the-art technology.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth types based on the provided document.
The document describes a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical trial results or performance metrics against pre-defined acceptance criteria for a novel device. The "Effectiveness" section states that it's "established by Philips's evaluation throughout all phases of the AcQPlan 5.0 development" and that "The product will perform in accordance with the development specifications," but it does not provide the specifics of these evaluations or specifications.
§ 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.