(128 days)
ART-Plan's indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available.
ART-Plan is not intended for patients less than 18 years of age.
The indicated users are trained medical professionals including, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists and medical professionals involved in the radiation therapy process.
The indicated use environments are, but not limited to, hospitals, clinics and any health facility involved in radiation therapy.
The ART-Plan application consists of three key modules: SmartFuse,Annotate and AdaptBox, allowing the user to display and visualise 3D multi-modal medical image data. The user may process, render, review, store, display and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks.
Compared to Ethos Treatment, 2.1; Ethos Treatment Planning, 1.1 (primary predicate), the following additional feature has been added to ART-Plan v2.1.0:
- generation of synthetic CT from MR images. This does not represent an additional . claim as the technological characteristics are the same and it does not raise different questions of safety and effectiveness. Also, this feature is already covered by reference and previous version of the device ART-Plan v1.10.1.
The ART-Plan technical functionalities claimed by TheraPanacea are the following:
- . Proposing automatic solutions to the user, such as an automatic delineation, automatic multimodal image fusion, etc. towards improving standardization of processes/ performance / reducing user tedious / time consuming involvement.
- . Offering to the user a set of tools to assist semi-automatic delineation, semi-automatic registration towards modifying/editing manually automatically generated structures and addina/removing new/undesired structures or imposing user-provided correspondences constraints on the fusion of multimodal images.
- . Presenting to the user a set of visualization methods of the delineated structures, and registration fusion maps.
- . Saving the delineated structures / fusion results for use in the dosimetry process.
- . Enabling rigid and deformable registration of patients images sets to combine information contained in different or same modalities.
- Allowing the users to generate, visualize, evaluate and modify pseudo-CT from MRI and CBCT images.
- . Allowing the users to generate, visualize and analyze dose on images of CT modality (only within the AdatpBox workflow)
- . Presenting to the user metrics to define if there is a need for replanning or not.
The provided document describes the acceptance criteria and the study that proves the ART-Plan device meets these criteria across its various modules (Autosegmentation, SmartFuse, AdaptBox, Synthetic-CT generation, and Dose Engine).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Autosegmentation Tool
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Quantitative (DSC) | a) DSC (mean) ≥ 0.8 (AAPM criterion) OR | |
| b) DSC (mean) ≥ 0.54 (inter-expert variability) OR | ||
| DSC (mean) ≥ mean (DSC inter-expert) + 5% | Duodenum: DICE diff inter-expert = 1.32% (Passed) | |
| Large bowel: DICE diff inter-expert = 1.19% (Passed) | ||
| Small bowel: DICE diff inter-expert = 2.44% (Passed) | ||
| Qualitative (A+B%) | A+B % ≥ 85% (A: acceptable without modification, B: acceptable with minor modifications/corrections, C: requires major modifications) | Right lacrimal gland: A+B = 100% (Passed) |
| Left lacrimal gland: A+B = 100% (Passed) | ||
| Cervical lymph nodes VIA: A+B = 97% (Passed) | ||
| Cervical lymph nodes VIB: A+B = 100% (Passed) | ||
| Pharyngeal constrictor muscle: A+B = 100% (Passed) | ||
| Anal canal: A+B = 98.68% (Passed) | ||
| Bladder: A+B = 93.42% (Passed) | ||
| Left femoral head: A+B = 100% (Passed) | ||
| Right femoral head: A+B = 100% (Passed) | ||
| Penile bulb: A+B = 96.05% (Passed) | ||
| Prostate: A+B = 92.10% (Passed) | ||
| Rectum: A+B = 100% (Passed) | ||
| Seminal vesicle: A+B = 94.59% (Passed) | ||
| Sigmoid: A+B = 98.68% (Passed) |
SmartFuse Module (Image Registration)
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Quantitative (DSC) | a) DSC (mean) ≥ 0.81 (AAPM criterion) OR | |
| b) DSC (mean) ≥ 0.65 (benchmark device) | No specific DSC performance values are directly listed for SmartFuse, but the qualitative evaluations imply successful registration leading to acceptable contours. | |
| Qualitative (A+B%) | Propagated Contours: A+B% ≥ 85% for deformable, A+B% ≥ 50% for rigid. | |
| Overall Registration Output: A+B% ≥ 85% for deformable, A+B% ≥ 50% for rigid. | for tCBCT - sCT (Overall Registration Output): Rigid: A+B%=95.56% (Passed); Deformable: A+B%=97.78% (Passed) | |
| for tsynthetic-CT - sCT (Propagated Contours): Deformable: A+B%=94.06% (Passed) | ||
| for tCT - sSCT (Overall Registration Output): Rigid: A+B%=70.37% (Passed) | ||
| Geometric | 2) Jacobian Determinant must be positive. |
- Target Registration Error (TRE)
§ 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.