(11 days)
Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes.
Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes.
The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care.
Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
Pinnacle3 Radiation Therapy Planning System version 7.2 (hereafter Pinnacle' RTP) provides radiation therapy planning for the treatment of benign or malignant diseases. When using Pinnacle3 RTP, qualified medical personnel may generate, review, verify, approve, print and export the radiation therapy plan prior to patient treatment. Pinnacle RTP can approvide plans for various radiation therapy modalities including External Beam Treatment, Stereotactic Radiosurgery, and Brachytherapy.
Pinnacle3 RTP is a software package that runs on a Sun UNIX (or UNIX compliant) computer and consists of a core software module (Pinnacle') and optional software features. These optional software features, commonly referred to as "plug-ins", are typically distributed separate from the core software product (separate CD-ROM). The device has network capability to other Pinnacle RTP workstations and to both input and output devices via local area network (LAN) or wide area network (WAN).
Image data is imported from CT, MR, PET, PET-CT and SPECT devices using a DICOMmage atta interface. A qualified medical professional uses the Pinnacles RTP for functions such as viewing and analyzing the patient's anatomy, and generating a radiation therapy plan. The viowing and analyzing are examples of tasks that may be performed by clinicians when using the Pinnacle' RTP system:
- Evaluate the treatment plan based on radiation-sensitive structures and the tumor. ◆
- Combine both geometric and dosimetric planning on the same platform, including CT . simulation data and plans. The CT simulation parts of the system are called AcQSim² and Simulation.
- Configure beam variables such as energy, geometry, and beam modifiers such as blocks, . wedges, multi-leaf collimators, bolus and compensators.
- Visualize the beam on a display, initiate the dose computation, and set the weight of each . beam.
- Obtain dose measurements from any Points of Interest (POI). .
- Perform photon and electron physics modeling, dose algorithm and machine ● commissioning. This functionality is supported by the Physics Utility Module.
- Evaluate images away from the workstation via a laptop or physician group workstation. . The feature that provides remote review is referred to as P3MD.
- Create data for use in conjunction with treatment QA systems. .
- Configure, backup, archive, restore, and scripting. .
- Evaluate Digitally Reconstructed Radiographs (DRRs) on Pinnacle RTP or remote system . using DICOM Secondary Capture (SC) Export.
Once complete, Pinnacle3 RTP has the ability to transfer the finished plan to other devices used in Onec comprete, I minute - Record and Verify, Linear Accelerator (Linac) Workstations and/or 310 Party QA systems.
The following Pinnacle³ RTP features are also available to assist the clinician with the radiation therapy planning process. These features are distributed on standalone CD-ROM media, and installed onto the Pinnacle' RTP workstation. Corresponding instructions for use such as User Guides or Release Notes are also provided to the clinician for each optional feature.
P3IMRT (Intensity Modulated Radiation Therapy):
P INKT (Incentines both forward and inverse planning functionality. The system determines a plan that satisfies the user's treatment goals through an optimization process. The user's treatment goals are specified as objectives and constraints based on dose distribution characteristics.
Syntegra (also referred to as AutoFusion):
Syntegra (utomates multi-modality image registration and fusion by overlaying images from CT, MR, PET, PET-CT and SPECT devices using a DICOM-compliant interface. This feature provides clinicians with the ability to relate, interpret and contour an image's anatomic and functional information.
In addition to the above, the following software options are available to facilitate image and/or data import and export between radiation therapy devices such as the imaging camera, Pinnacle' RTP, and Record & Verify system. DICOM is the acronym for Digital Imaging and Communications in Medicine and is an internationally recognized standard for transferring biomedical information such as images and data between devices or over a network.
DICOM RT:
DICOM RT software is used to support both Structure Set and Radiation Therapy Plan import and export functions. Structure Sets describe regions and points of interest to other systems. Plan information includes beam geometry and delivery information.
DICOM Image:
DICOM Image software is used to support image import and export to and from the Pinnacle RTP workstation according to the NEMA DICOM standard, version 3.0. This functionality allows diagnostic imaging devices supporting the DICOM 3.0 standard to interface with the Pinnacle system.
Mitsubishi DME:
A proprietary interface has been created within the Pinnacles Treatment Planning System to support plan export to Mitsubishi Record and Verify systems. This interface is called the "Mitsubishi DME" system. This is implemented as a simple file based interface according to a format specified by Mitsubishi.
P3 MD:
P3MD allows for treatment plan review and minor alternations by a physician from a PC-based workstation that is connected to the same network as the primary Pinnacle Treatment Planning workstation.
The provided text is a 510(k) Pre-market Notification for the Pinnacle3 Radiation Therapy Planning System version 7.2. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.
Key takeaway regarding "acceptance criteria" and "study proving acceptance criteria":
510(k) notifications, especially for software modifications to existing devices like this one, do not typically present formal "acceptance criteria" and "studies proving acceptance criteria" in the same way one would find for a novel device or a clinical trial. Instead, they focus on demonstrating substantial equivalence to a predicate device.
Here's a breakdown of why and what information is available from the document:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable in a traditional sense for this document. The concept of "acceptance criteria" for this submission would be demonstrating that the new features (DMLC support, physics tool improvements) function as intended and do not raise new safety or effectiveness concerns compared to the predicate device.
- The document explicitly states: "Verification and Validation test plans were completed in compliance with ADAC Laboratories procedures and will be utilized to demonstrate that the Pinnacle Radiation Therapy Planning System version 7.2 has met its specifications, demonstrates substantially equivalent performance to the predicate device and is safe and effective for its intended use."
- The specific "reported device performance" against quantifiable "acceptance criteria" for the new features (e.g., DMLC accuracy within X%, physics model improvement by Y%) is NOT detailed in this summary. Such details would be part of the internal ADAC Laboratories verification and validation documentation, which is reviewed by the FDA but not typically fully included in the public 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified in the publicly available summary. The summary refers to "Verification and Validation test plans" but does not detail the specifics of test sets, sample sizes, or data provenance.
- Given this is a software update and not a new diagnostic tool interacting directly with patient data, a "test set" in the sense of clinical images might not be the primary focus of the V&V. It would likely involve testing the software's computational accuracy and functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified. The document mentions the involvement of "qualified medical personnel" for using the system and evaluating plans, but does not detail their role in establishing ground truth for testing the device itself.
- For radiation therapy planning systems, "ground truth" often relates to known physics principles, phantom measurements, or comparisons to established planning systems for dose calculations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. This is typically relevant for studies involving human interpretation or subjective assessments, which are not directly described for this software update.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was explicitly NOT required. The document states: "Summary of Clinical Tests: Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness."
- This also means there is no reported effect size for human readers improving with AI, as the device is not presented as an "AI assistance" tool in this context, but rather an updated radiation therapy planning system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The "Verification and Validation test plans" would have involved standalone testing of the algorithms (e.g., dose calculation, DMLC path generation) to ensure they meet specifications. However, the details of these standalone tests are not provided in the summary. The device's function is inherently "algorithm only" in terms of its core computations, with human oversight for plan approval.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in the summary. For a radiation therapy planning system, ground truth for dose calculation and DMLC functionality would likely involve:
- Physics models: Comparison of calculated dose distributions to established physics models and phantom measurements.
- Reference data: Comparison of DMLC movements to designed or theoretical paths.
- Simulations against known parameters.
- It would not typically involve expert consensus on image interpretation, pathology, or patient outcomes data for device validation in a 510(k) for a dose planning system update.
8. The sample size for the training set:
- Not applicable. This device is a radiation therapy planning system, not a machine learning model that requires a "training set." It is based on deterministic physics algorithms and software logic.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
In summary of the provided text:
The document is a 510(k) submission focused on demonstrating substantial equivalence of an updated radiation therapy planning system (Pinnacle3 version 7.2) to a previously cleared version (K032724). The primary changes are support for dynamic multileaf collimator (DMLC) treatment planning and improvements to the physics tool.
The "study that proves the device meets the acceptance criteria" is broadly referred to as:
"Verification and Validation test plans were completed in compliance with ADAC Laboratories procedures and will be utilized to demonstrate that the Pinnacle Radiation Therapy Planning System version 7.2 has met its specifications, demonstrates substantially equivalent performance to the predicate device and is safe and effective for its intended use."
However, the detailed methodology, specific acceptance criteria, test set sizes, ground truth establishment, or clinical study outcomes are not contained within this public 510(k) summary. These details would be part of the complete 510(k) submission reviewed by the FDA, but are not disseminated in the public summary. The FDA determined that clinical testing was "not required" for this particular device update.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.