(9 days)
Pinnacle 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.
Pinnacle 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.
SmartArc is a module for creating intensity modulated arc therapy plans.
The SmartArc module is an extension of PIMRT that adds dynamic arc capabilities. A Dynamic Arc beam is similar to the current Conformal Arc bean but does ot impose the restrictions of a constant does rate or blocking a specific target.
The SmartArc solution utilizes continuous gantry motion in which the field shape defined by a multi-leaf collimator changes during gantry rotation. The dose rate can also be changed during rotation of the gantry.
Creation of a Dynamic Arc beam will be accomplished through a SmartArc optimization. The user will create a default Dynamic Arc beam, enter IMRT, assign objectives and perform a SmartArc optimization to provide an intensity Modulated Arc Treatment )IMAT) plan.
This extends the functionality of the Pinnacle3 Radiation Therapy Planning System (hereafter Pinnacle RTP) that provides radiation therapy planning for the treatment of benign or malignant diseases. When using Pinnacle RTP, qualified medical personnel may generate, review, verify, approve, print and export the radiation therapy plan prior to patient treatment. Pinnacle RTP can provide plans for various radiation therapy modalities including External Beam Treatment, Stereotactic Radiosurgery, and Brachytherapy.
Pinnacle RTP is a software package that runs on a Sun UNIX workstation 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).
This software automates multi-modality image registration and fusion by overlaying images from CT. MR. PET. PET-CT, and SPECT devices. This feature provides clinicians with the ability to relate, interpret and contour and image's anatomic and functional information.
The provided text describes the 510(k) premarket notification for the Philips Medical Systems (Cleveland), Inc. Pinnacle3 Radiation Therapy Planning System SmartArc Module. However, it does not contain explicit acceptance criteria in a quantitative format or a detailed study proving the device meets specific performance criteria as typically found in clinical validation studies.
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against pre-defined acceptance criteria through detailed clinical or non-clinical testing results.
Here's a breakdown of the information that can be extracted, and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the document. The submission focuses on demonstrating substantial equivalence, meaning the device performs similarly to existing legally marketed devices, rather than meeting specific numerical performance targets.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified. The document states a "Summary of Non-Clinical Tests" was completed, but does not detail the size or nature of the test cases used for verification and validation.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. As clinical testing was not deemed necessary for substantial equivalence, there's no mention of experts or ground truth establishment for a test set in the context of clinical performance.
4. Adjudication Method for the Test Set:
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No. The document explicitly states: "Summary of Clinical Tests: Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness." Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or reported in this submission.
- Effect Size: Not applicable, as no such study was performed.
6. Standalone (Algorithm Only) Performance Study:
- Was it done?: Not explicitly as a separate performance study with reported metrics. The "Summary of Non-Clinical Tests" mentions "Verification and Validation test plans were completed...to demonstrate that the Pinnacle Radiation Therapy Planning System SmartArc has met its specifications, demonstrates substantially equivalent performance to the predicate devices and is safe and effective for its intended use." This suggests internal testing of the algorithm's functionalities and adherence to specifications, but no detailed, standalone performance metrics (e.g., accuracy, precision) are provided for the SmartArc module itself. The focus is on the dose computation algorithms (CCCS, SVD) which are part of the overall system.
7. Type of Ground Truth Used:
This information is not explicitly provided for the "test set" in the context of a performance study. For the internal verification and validation, the ground truth would likely be established by comparing algorithm outputs against known physics models, theoretical calculations, and potentially against predicate device performance.
8. Sample Size for the Training Set:
This information is not provided. As the device uses established dose computation algorithms (CCCS, SVD) and is an extension of existing software, it's unlikely there was a separate "training set" in the machine learning sense that would require a specified sample size. The algorithms themselves are based on physics models rather than deep learning training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided, as the concept of a "training set" with established ground truth in the typical machine learning sense doesn't directly apply here. The dose computation algorithms described (CCCS, SVD) are physics-based models, and their "ground truth" comes from fundamental physics principles, Monte Carlo simulations, and established mathematical formulations (as indicated by the references to Mackie et al. and Bortfeld).
§ 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.