(254 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Specifications: | |
| Plan radiation therapy treatments on linear accelerators, teletherapy devices (x-ray: 4-50 MV, cobalt-60, electron: 4-50 MeV) for entire human anatomy. | The device is intended to perform these functions. The statement "The product will perform in accordance with the development specifications" indicates internal testing, but no specific performance metrics or thresholds are provided for review. |
| Support techniques: asymmetrically collimated fields, irregular fields, multi-leaf collimators, non-coplanar fields, bolus, fixed wedges, Varian's enhanced dynamic wedges. | The device allows for these techniques. Similar to above, no performance metrics are given. |
| Account for heterogeneities (photon beams) using Batho method (two versions) or Equivalent TAR (ETAR) method. | The device allows for these methods. No specific accuracy or precision of heterogeneity correction is reported. |
| Use generalized Gaussian pencil beam model for electron beams. | The device uses this model. No specific accuracy or precision of the electron beam calculations is reported. |
| Simultaneously visualize target, normal tissues, and computed 3-D dose distributions in real-time. | The device allows for this visualization. "Great detail" is a qualitative claim. |
| Develop treatment plans in a coordinate system accurately fixed to set-up marks (using CT and multi-modality info). | The device develops plans this way. No quantitative accuracy is given. |
| Provide tools for managing competing/complementary plans and comparing plans (based on DVH plots). | The device provides these tools. No performance metrics are given for the effectiveness or accuracy of these tools. |
| Generate high-quality DRRs and DCRs (with BEV and beam graphics superimposed) to replace conventional simulator films. | The device generates these. "High quality" is a qualitative claim. No specific image quality metrics or comparisons to conventional films are provided. |
| Safety and Effectiveness: | |
| Conformity to FDA 21 CFR 820 (Quality System Regulation). | Picker "adheres to FDA 21 CFR 820". |
| Conformity to UL 187 (voluntary standard for safety and effectiveness, minimizing electrical, mechanical, radiation hazards). | Picker "adheres to... UL 187". |
| Conformity to IEC 601-1. | System "designed to conform to IEC 601-1". |
| Substantial equivalence to legally marketed devices. | FDA reviewed and determined the device is substantially equivalent (K974770). This is the primary "effectiveness" claim in a 510(k). |
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.
§ 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.