(267 days)
PLANET Onco Dose is a standalone software intended to manage, process, display and analyze anatomical and functional images. It provides tools and functionalities to assist in medical diagnosis and therapy response assessment, to assist in the contouring of regions of interest, and to assist in internal dosimetry computation for radionuclide based therapies. The modalities of these medical imaging systems include CT, MRI, SPECT, PET, XA, planar scintigraphy, RT Struct and RT Dose as supported by ACR/NEMA DICOM 3 standard format.
PLANET Onco Dose is intended for retrospective determination of dose only and should not be used to deviate from approved radioactive products, product dosing and administration instructions.
PLANET Onco Dose is dedicated to be used by qualified medical professionals in Molecular Imaging, and/or Medical Oncology.
PLANET Onco Dose provides the User with the means to segment structures in medical image volumes by providing dedicated delineation, contouring and propagation tools for both tumors and normal tissues (i.e. Regions of Interest (ROI)).
PLANET Onco Dose provides tools to display, co-register (rigid and deformable), perform quantification for assessment and response evaluation of patients undergoing a course of oncology treatment.
PLANET Onco Dose allows import / export of results (contours and dosimetries) to / from any DICOM compliant system (e.g. Treatment Planning Systems, PACS).
PLANET Onco Dose allows to compute in 3D at the radiation doses received by tissues as a result of radionuclide administration. Dose can be computed with or without tissue density correction using two models depending on considered isotopes.
PLANET Onco Dose provided the User with the means to perform modeling of absorption and elimination kinetics of Radiopharmaceutical Therapy (RPT). Time-integrated activity and dose rate can be calculated from three kinds of clinical setups involving full 3D image acquisitions, hybrid 2D/3D image acquisitions and single time point approaches.
PLANET Onco Dose supports isotopes with beta and gamma contributions.
PLANET Onco Dose provides tools for dosimetry comparison for sequential treatments and for dosimetry summation.
PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, contouring, internal dosimetry computation and therapy response assessment, using molecular imaging modalities.
PLANET Onco Dose is a modular software suite composed of three elements:
. PLANET - Core System: reviewing, fusion and registration of multi-modal anatomical (computed tomography (CT), magnetic resonance imaging (MRI), X-ray angiography (XA)) and functional (positron emission tomography (PET), single photon emission computed tomography (SPECT), planar scintigraphy) series;
. PLANET Onco - Oncology Module: contouring of region of interest, tumor segmentation, quantification, therapy response assessment;
. PLANET Dose - Dosimetry Module: pharmacokinetics modeling and internal dosimetry computation for locally regulatory approved pharmaceuticals.
The provided document describes the PLANET Onco Dose (3.2) software, intended for medical image management and processing, dosimetry computation, and therapy response assessment. While it details the device's intended use, technological comparisons, and that performance testing was conducted, it does not provide specific acceptance criteria or the numerical results of performance, functional, or algorithmic testing.
Therefore, I cannot populate the table or answer most of the questions using only the provided text.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (e.g., Specificity, Sensitivity, Accuracy, Dice Score, ROC AUC) | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Not specified in the provided document. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. The document states "validation activities under clinically representative conditions" but does not detail the origin (e.g., country, hospital, retrospective/prospective) of the data used for actual testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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 specified. The document mentions "The critical evaluation of the relevant scientific literature confirms that the choices made for the TRT dosimetry computation methods implemented within PLANET Onco Dose are those recommended by the scientist international community," which might imply comparisons, but it doesn't describe an MRMC study related to human performance improvement with AI assistance for PLANET Onco Dose (3.2) itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The document states, "PLANET Onco Dose was submitted to performance, functional and algorithmic testing," and later, "The performance obtained by the demonstration of performances lead to clearly define the area of application of the various internal dosimetry methods." The comparison of its dose computation algorithms with Monte Carlo methods also suggests standalone algorithmic evaluations. However, specific standalone performance metrics are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for all tests. For the dosimetry comparison, it mentions "Dose computation algorithms available in PLANET Onco Dose were compared with Monte Carlo method and the results showed consistency between evaluated methods." This implies Monte Carlo results may have been used as a reference/ground truth for dosimetry algorithm validation. For other functionalities like contouring, it's not specified how ground truth was established, but typically this would involve expert consensus on medical images.
8. The sample size for the training set:
- Not specified. The document does not describe a training set, as it focuses on the performance and validation of the software. This suggests it's likely a rule-based or conventional algorithmic software rather than a deep learning AI model that requires a distinct training phase.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as no training set is described.
Summary of Device and Study Information from the Document:
PLANET Onco Dose (3.2) is a standalone software for managing, processing, displaying, and analyzing anatomical and functional images. It assists in medical diagnosis, therapy response assessment, contouring of regions of interest, and internal dosimetry computation for radionuclide-based therapies.
Key Study Information:
- Testing Conducted: Performance, functional, and algorithmic testing, risk management assessment (including cybersecurity), and validation activities under clinically representative conditions.
- Workflows Covered: Standard SIRT, Full SPECT/CT pharmacokinetics for MRT, 2D/3D hybrid pharmacokinetics for MRT, Single time point pharmacokinetics for MRT.
- Dosimetry Algorithm Comparison: PLANET Onco Dose's Voxel S Value dose kernel convolution algorithm and local energy deposition algorithm were compared with the Monte Carlo method, showing "consistency."
The document concludes that the results demonstrate the safety and effectiveness of PLANET Onco Dose (3.2) and that it is substantially equivalent to its predicate devices (PLANET Onco Dose (3.1) and Torch™). However, it lacks the quantitative results of these tests and the specifics of the methods (e.g., sample sizes, expert qualifications) used to establish ground truth or evaluate performance against acceptance criteria.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).