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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.

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The ACQPLAN is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan 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, fixed wedges, and Varian's enhanced dynamic wedges. It allows the treatment planner to take heterogeneities into account 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 AcQPlan, 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, using CT and multi-modality information 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 DRRs and DCRs (digitally composited radiographs), 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

The ACQPLAN is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan 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, fixed wedges, and Varian's enhanced dynamic wedges. It allows the treatment planner to take heterogeneities into account 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 AcQPlan, the treatment planner can simultaneously visualize target 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, using CT and multi-modality information 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 DRRs and DCRs (digitally composited radiographs), 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 provided text for the Picker K974770 ACQPLAN describes a radiation therapy treatment planning system. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving device performance.

The document is a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results for novel performance claims.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Cannot Answer Based on Text:

The provided text does not include information on the following, as it is a 510(k) summary focused on substantial equivalence rather than a detailed clinical or performance study report:

• Specific study proving the device meets acceptance criteria: The document states, "Effectiveness is established by Picker's evaluation throughout all phases of the ACQPLAN development. The product will perform in accordance with the development specifications." This describes internal development and verification, not a formal, independent study with reported metrics. It also mentions a review of "all known information and performed an investigation," but no details of this investigation are provided.
• Sample size used for the test set and data provenance: No information on a specific test set is provided beyond internal development testing.
• Number of experts used to establish ground truth for the test set and their qualifications: Not applicable, as no external test set is detailed.
• Adjudication method for the test set: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. There is no information about human readers or comparisons with AI assistance.
• Standalone (algorithm-only) performance: While the ACQPLAN is an "integrated 3-D RTP and simulation system," the text describes its intended functions, not a standalone performance evaluation against a specific metric.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not detailed for any specific performance study.
• Sample size for the training set: Not applicable, as no machine learning algorithm development (in the modern sense) or specific training set is discussed or implied for performance claims.
• How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) notice establishes the ACQPLAN's intended use and claims substantial equivalence to predicate devices, supported by adherence to regulatory and voluntary standards and internal development processes. However, it does not include the detailed performance study data, acceptance criteria with quantitative metrics, or methodological specifics (like sample sizes, expert qualifications, or ground truth establishment) that would be present in a comprehensive study report for a new device claiming specific performance metrics.

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