(141 days)
Pinnacle3TM Radiation Therapy Planning Software 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 Software 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 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 software 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 Treatment Planning Software is a system composed of a Sun Unix workstation running the Solaris operating system and software which provides the user with the capability to enter patient data into the system, use that data to construct a plan for radiation therapy, and evaluate the plan.
The system consists of a number of functional areas: physics, image import, image manipulation, contouring, point definition, photon and electron external beam treatment planning, stereotactic radiosurgery, brachytherapy, plan evaluation, file management and connectivity. Photons, electrons, stereotactic radiosurgery and brachytherapy functions are sold as separate options and may or may not be included in every system.
Pinnacle 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. Plans generated using this software 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.
The provided text is a 510(k) summary for the Pinnacle3™ Radiation Therapy Planning Software. It outlines the device description, intended use, and comparison to predicate devices. However, it explicitly states that clinical testing was not performed as part of the development and thus, there isn't detailed information about acceptance criteria, performance data, or specific study methodologies for proving device performance in a clinical context.
Therefore, for aspects related to clinical acceptance criteria and studies (points 1-7, and 9) the information is limited or non-existent in this document.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The document instead refers to "specifications" for non-clinical testing.
- Reported Device Performance: No clinical performance data is reported. The document states: "Verification and Validation testing were completed in compliance with ADAC Laboratories procedures to demonstrate that the Pinnacle Radiation Therapy Planning Software has met all its specifications, demonstrates substantially equivalent performance to its predicate devices, and is safe and effective for its intended use." This indicates regulatory compliance and substantial equivalence to predicates, not specific performance metrics against defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set details are provided.
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 applicable. No clinical test set details or ground truth establishment are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set details are provided.
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
- Not applicable. No clinical studies, MRMC studies, or AI assistance details are mentioned. The device is a "Radiation Therapy Planning System," not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies standalone testing was done for "Verification and Validation" to ensure it met "specifications." However, this is in the context of a "Radiation Therapy Planning Software" which assists the clinician. The performance referred to is likely the accuracy and reliability of the planning algorithms themselves, not a diagnostic task where standalone performance is measured against human performance for comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical ground truth. For the "Verification and Validation testing" of the software, the "ground truth" would likely be based on established physics principles, dose calculation algorithms, and comparisons to known accurate treatment plans (potentially from predicate devices or phantom studies). The document does not specify.
8. The sample size for the training set
- Not applicable. As this is a 510(k) for a radiation therapy planning system (not an AI model in the modern sense), the concept of a "training set" for machine learning algorithms does not apply based on the provided information.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as point 8.
§ 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.