(242 days)
PLATO 3-D Treatment Planning System is used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop plans for external photon and electron therapy. PLATO External Beam Planning RTS V2 and RTS 3D V2 has intended uses equivalent to its predecessor PLATO RTS V1. This device is used for external beam radiation therapy treatment planning for localization and treatment planning of malignant and benign lesions of patients. Treatment of cancer may require use of external radiation beams from an external source. Teletherapy unit coordinates of beam placement including gantry angle, field size, and shape along with accurately calculated predicted dose computation, are necessary in present day planning for radiotherapy. The ability to calculate both coplanar and noncoplanar beams to a highly accurate level is desirable by the industry. PLATO RTS V 2 allows for accuracy and speed to clinically facilitate this need. The recent use of linear accelerator Multileaf Collimators for field shaping is desired and supported by RTS V2.
The PLATO 3-D Treatment Planning System described in this submission is a computer-based external beam and brachytherapy treatment planning system for clinical radiation therapy applications. Based on an individual patient's anatomical information obtained from radiographs, CT or MRI scans, a treatment setup or source configuration, including insertion times for brachytherapy, is defined and the resultant dose distribution is calculations rely on physical algorithms describing the radiation transport process which finally leads to dose deposition inside a patient's anatomy. Treatment set-up, or source parameters, are changed until the corresponding dose distribution are clinically acceptable. The operator performing the treatment planning forms part of the PLATO Radiation Treatment Planning System. The prescribed treatment is then administered to the patient, utilizing medical linear accelerators, cobalt units, afterloaders, or manual techniques. The PLATO 3-D Treatment Planning System is modular in structure and consists of the following main features which are depicted in the attached system overview diagram. RTS - A module for External Beam planning EVAL 2.0 - An evaluation module for combination of external and brachytherapy planning using evaluation tools; IPS-CT - Imports images from CT, MRI, radiographs and outlining features; MLC - Multileaf Collimator
The provided text describes the PLATO 3D Radiation Therapy Planning System (K904206) but lacks the detailed information required to fill in all sections of the acceptance criteria and study description. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to manufacturing standards rather than presenting specific performance study results with quantitative metrics.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the PLATO 3D Radiation Therapy Planning System. It emphasizes internal performance standards, adherence to design specifications, and equivalence to predicate devices.
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document mentions "standards specified by Nucletron" and "product design specifications" for internal performance standards, and "accuracy" but without quantitative values. | The document states "Function and Dose calculation parameters have been tested" and that the device "allows for accuracy and speed to clinically facilitate this need." However, no specific performance results (e.g., accuracy percentages, error margins, speed metrics) are provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "Function and Dose calculation parameters have been tested," but it does not specify the sample size of the test data (e.g., number of patient cases, number of dose calculations), the type of data used (e.g., phantom studies, patient data), or its provenance (country, retrospective/prospective).
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)
This information is not provided in the document. The document refers to the operator forming part of the system and clinical application specialists, but it does not describe a formal expert panel or their qualifications for establishing ground truth for any testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. There is no mention of an adjudication process for any testing.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The device is a treatment planning system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output. The focus is on the accuracy of dose calculation and treatment plan generation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that "the resultant dose distribution is calculations rely on physical algorithms describing the radiation transport process which finally leads to dose deposition inside a patient's anatomy." It also mentions "Function and Dose calculation parameters have been tested." This implies that the dose calculation algorithm, a core standalone component, was tested. However, no specific standalone performance metrics or study details are provided. The system is designed to have a "human-in-the-loop" ("The operator performing the treatment planning forms part of the PLATO Radiation Treatment Planning System."), but testing of the algorithms themselves would be a standalone assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated for any testing that may have been performed. For a radiation therapy planning system, ground truth for dose calculation is typically established through:
- Physics phantom measurements: Physical measurements of dose distribution in phantoms.
- Established analytical or Monte Carlo simulation models: Comparison against highly accurate and validated computational models.
- Clinical validation against known outcomes for simplified cases: Less common for initial clearance but could be part of post-market surveillance.
The document mentions "physical algorithms describing the radiation transport process," suggesting a theoretical approach, but how this was validated against a definitive "ground truth" (e.g., specific experimental data) is not detailed.
8. The sample size for the training set
This information is not applicable/provided. The PLATO 3D system described in this 1996 document is a rule-based, algorithm-driven system for dose calculation and treatment planning, not a machine learning or AI system that requires a "training set" in the modern sense. It relies on physical models and algorithms.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reason as point 8. The device is based on physics algorithms, not learned from a training set.
Summary of Gaps:
The [K904206](https://510k.innolitics.com/search/K904206) document is a 510(k) submission from 1996 for a radiation therapy planning system. It predates many of the rigorous, quantitative performance study requirements and reporting standards common for AI/ML-driven medical devices today. Its primary focus is on establishing substantial equivalence to existing predicate devices based on intended use, manufacturing quality (ISO 9001, GMP), and internal verification/validation processes, rather than presenting detailed prospective clinical efficacy studies with quantitative acceptance criteria. Therefore, most of the specific details requested regarding test sets, ground truth establishment, expert involvement, and MRMC studies are not available in the provided text.
§ 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.