(169 days)
THERAPLAN Plus Version 1.2 is intended to be used as a modelling system to assist health care professionals determine a course of Radiation Therapy to be delivered to a patient with cancer. It is designed to be used directly by a health care professional capable of assessing the suitability of the output for treatment planning purposes, or to have its output reviewed by someone with these qualifications prior to use.
THERAPLAN Plus Version 1.2 consists principally of application software running under a Windows operating system on a Pentium personal computer. Several THERAPLAN Plus Version 1.2 systems can be networked together for common access to pertinent data. The principal components of the THERAPLAN Plus Version 1.2 are listed below.
Hardware platform and Operating System: Pentium PC, Windows NT
Peripherals and accessories: Electromagnetic digitizer for manually entering patient anatomy, film scanner for entering anatomy from films, 9 track magnetic tape unit for entering CT and MR images of patient anatomy, laser text printer, 300 dpi, 4 pages per minute minimum, colour printer, 300 dpi.
Main software features:
Unit Modelling of electron and photon beams from accelerators or Cobalt therapy units. Includes entry of wedges, blocks, and multileaf collimators.
Source Modelling of point sources, line sources and wires. The operator selects parameters for the sources which are required for treatment planning, such as size, isotope, wall thickness, and half-life.
Patient Data Acquisition by means of CT or MR images, a film scanner, or manually entered contours. CT or MR data may be acquired directly for units which support the DICOM 3 image format and communication standard, or by means of a software interface supplied by Theratronics for other units.
Anatomy Modelling to prepare the patient data for treatment planning. The portions of the anatomy which are of interest are selected, and contouring is performed of the anatomy exterior, the treatment target volume, and interior organs as needed for treatment planning.
Brachytherapy Planning may be performed using sources established during Source Modelling. The location of multiple sources may be specified and sample dose calculations performed. The location of sources may be adjusted for optimization. Timedomain calculations may also be performed based on the pattern of sources and their halflives.
External Beam Planning may be performed using Unit Modelling data and Anatomy Modelling data. Electron and/or photon beams of different treatment units may be applied, and dose calculations performed. The location of the beams may then be adjusted for optimization. Arc therapy treatments can also be modeled.
The THERAPLAN Plus Version 1.2 also includes facilities for the operator to print the treatment plan information for review and to assist with the patient's treatment, and a compensator can be designed to help optimize the radiation pattern of an applied beam.
The provided text for the THERAPLAN Plus Version 1.2 510(k) submission describes the device, its features, and intended use, and concludes that its development and validation are in compliance with Theratronics product development procedures. These procedures reportedly ensure that system testing and validation demonstrate that the system meets its published specifications, performs as well as or better than predicate products, and is safe and effective for its intended use.
However, the provided document does not explicitly state specific acceptance criteria (metrics with numerical thresholds) or detail a standalone study that directly proves the device meets these criteria. The text primarily focuses on describing the device's functionality and its substantial equivalence to predicate devices. The "Conclusion" section makes a general statement about meeting specifications and performing comparably to predicate devices, but lacks the specific data requested regarding acceptance criteria and a dedicated study to prove it.
Therefore, the following information is not explicitly available in the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are listed, nor are numerical results presented against such criteria.
- Sample size used for the test set and the data provenance: No information about a specific test set, its size, or its origin (e.g., country, retrospective/prospective) is provided for a performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No details are given about how ground truth was established for any test data.
- Adjudication method for the test set: No adjudication method is mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: The document does not describe an MRMC study or any comparison of human readers with vs. without AI assistance. The device is a "Radiation Therapy Treatment Planning System" which assists healthcare professionals, but it's not an AI specifically designed to improve human reader performance in a diagnostic sense.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document does not describe a standalone performance study. The device is intended to be used by healthcare professionals.
- The type of ground truth used: No specific type of ground truth (e.g., pathology, outcomes data) is mentioned for any performance evaluation.
- The sample size for the training set: No information regarding a training set or its size is provided.
- How the ground truth for the training set was established: No information regarding ground truth establishment for a training set is provided.
Based on the provided text, the THERAPLAN Plus Version 1.2 is a "Radiation Therapy Treatment Planning System." Its validation focused on compliance with Theratronics product development procedures, aiming to ensure it meets published specifications and performs as well as or better than predicate products. However, the document does not furnish the specific details of a performance study demonstrating quantitative acceptance criteria.
§ 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.