(36 days)
Pinnacle3 Radiation Therapy Planning System version 6.6 provides support for conformal arc treatment planning.
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.
Pinnacle Radiation Therapy Planning Software version 6.6 (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 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' 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 DICOM-compliant interface. A qualified medical professional uses the Pinnacle RTP for functions such as viewing and analyzing the patient's anatomy, and generating a radiation therapy plan.
The provided document is a 510(k) premarket notification for the Pinnacle3 Radiation Therapy Planning System version 6.6. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed acceptance criteria, specific study designs, or reported device performance metrics in the format requested.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed reported device performance in the format of a table. It states that "Verification and Validation test plans were completed in compliance with ADAC Laboratories procedures and will be utilized to demonstrate that the Pinnacle3® Radiation Therapy Planning Software version 6.6 software has met its specifications, demonstrates substantially equivalent performance to the predicate devices and is safe and effective for its intended use."
However, the specific metrics, thresholds, or outcomes of these verification and validation tests are not disclosed in this summary. The primary "performance" stated is that it "introduces support for conformal arc treatment planning" and "incorporates no technological characteristics not currently contained in the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention a specific "test set" in the context of clinical data. The review is based on non-clinical tests (Hazard Analysis, Verification and Validation test plans). Therefore, there is no information on sample size for a test set (e.g., number of patient cases, images) or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Given that clinical testing was "not required," there is no mention of experts establishing a ground truth for a test set. The validation would have been against software specifications and potentially comparison with predicate device outputs, rather than comparison against expert human performance on clinical cases.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set using expert judgment is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The submission states, "Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness." Therefore, there is no information on the effect size of AI assistance for human readers.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study in the context of clinical outcomes or diagnostic accuracy is not explicitly detailed. The non-clinical tests (Verification and Validation) would have evaluated the algorithm's functionality and performance against its specifications and potentially against outputs from predicate devices. However, these are software engineering tests rather than clinical performance studies.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" would likely be:
- Software Specifications: The predefined functional and performance requirements of the Pinnacle3 software.
- Predicate Device Output: Comparison of the new version's output (e.g., dose calculations, plan generation) against that of the predicate devices for equivalence, especially for the new "conformal arc treatment planning" feature.
- Expected Physics Principles: Ensuring that dose calculations and planning adhere to established radiation therapy physics.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for "clinical" performance, as clinical testing was not performed.
8. Sample Size for the Training Set:
This document is for a software update to a radiation therapy planning system. Radiation therapy planning systems are typically rule-based and physics-based software, or they might integrate machine learning components for specific tasks (e.g., auto-contouring, dose prediction). However, the document does not suggest the use of a machine learning model that would require a "training set" in the traditional sense. Therefore, no information on a training set size is provided.
9. How Ground Truth for the Training Set was Established:
Not applicable, as no training set for a machine learning model is mentioned.
Summary regarding acceptance criteria and study data:
The 510(k) notification for Pinnacle3 Radiation Therapy Planning System version 6.6 demonstrates substantial equivalence through non-clinical testing, hazard analysis, and comparison to predicate devices. It does not provide details on specific quantitative acceptance criteria or clinical study results with human expert involvement, as clinical testing was deemed unnecessary for this submission. The "study" referenced is the Verification and Validation test plans which demonstrated the software met its specifications and performed substantially equivalently to predicate devices.
§ 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.