(131 days)
PLANET Onco Dose is a standalone software intended to be used with PET or SPECT hybrid imaging systems in order to manage, process, display and analyze nuclear medical medical image series, to assist in medical diagnosis, to assist in treatment analysis and in therapy response assessment, to assist in the contouring of region of interest for radiotherapy.
PLANET Onco Dose is dedicated to be used by qualified medical professionals in Molecular Imaging, and/or Medical Oncology.
The medical modalities of these medical imaging systems include CT. MRI, SPECT, PET. XA, RT Struct and RT Dose as supported by ACR/NEMA DICOM 3 standard format.
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 (including deformable registration), compute Standardized Uptake Value (SUV) and import / export results (contours and dosimetries) to / from Treatment Planning Systems (TPS) and PACS devices for assessment and response of patients undergoing a course of oncology treatment.
PLANET Onco Dose provides the user with the means to assist in the assessment quantification of radiation doses received by tissues as a result of administering a radionuclide (e.g. Permanent Yttrium-90 microsphere implants).
PLANET Onco Dose provides tools for post-treatment absorbed dose calculation and evaluation on PET and SPECT images. The following functions are available to allow dose calculations for patients after they have received a treatment using permanent Yttrium-90 (Y90) microspheres:
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3D liver-lung shunt assessment;
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Local Deposition Model;
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Voxel S Value approach based on the schema in MIRD Pamphlet 17 [1]:
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Dosimetry based on 90Y-microspheres-PET (or SPECT Bremsstrahlung) series;
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Compatible with PET images acquired with another radioisotope instead of Y90 when Y90 acquisitions are not supported by the scanner (correction of branching ratio and decay parameters).
For Y90 microspheres. PLANET Onco Dose cannot be used to prescribe the radionuclide activity to be administered to the patient for the therapy. The user has to provide the parameters (e.g. activity) in order for PLANET Onco Dose to estimate the radiation doses that the tissues received as a result of the administration.
PLANET Onco Dose should only be used for the retrospective determination of dose and not for the case where is a need for retreatment using Y90 microspheres.
PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.
PLANET Onco Dose is a modular software suite composed of three elements:
- PLANET: Core System: license controller, reviewing of multi-modal molecular image series -(PET/CT, SPECT/CT, PET/MRI, SPECT/MRI): fusion and registration;
- -PLANET Onco: Oncology Module: contouring of region of interest, turnor segmentation, tumoral activity monitoring, therapy response assessment;
- -PLANET Dose: Dosimetry Module: internal dosimetry computation for the Targeted Radionuclide Therapy (TRT).
The provided text describes a 510(k) premarket notification for a medical imaging software called PLANET Onco Dose (K182966). It aims to demonstrate substantial equivalence to a predicate device (Velocity K173636).
However, the document does not contain the specific details about acceptance criteria, the study design (e.g., sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance), or the training set information (sample size, ground truth establishment) typically expected for a performance study proving a device meets acceptance criteria.
The "Performance Testing - Bench" section (Item 8) is very high-level and states: "PLANET Onco Dose was submitted to performance, functional and algorithmic testing, risk management assessment and validation activities under clinically representative conditions. The results of performance, functional and algorithmic testing, risk management assessment and validation activities under clinically representative conditions demonstrate the safety and effectiveness of PLANET Onco Dose." This is a general statement of compliance, not a detailed report of a study.
Therefore, I cannot fulfill most of the requested information based on the provided text.
Here's what can be inferred or stated about the acceptance criteria and the "study" based on the very limited information provided:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device, focusing on similar technological characteristics and functionalities. The comparison table (pages 6-7) lists features and functionalities of PLANET Onco Dose and its predicate, implying that meeting the functionalities of the predicate is a key "performance" aspect.
Since no specific quantitative acceptance criteria or detailed performance data are provided, a table cannot be constructed. The overall "performance" claim is that the device "meets the requirements of the device, its user needs and intended use, which are demonstrated to be substantially equivalent to those of the predicate device."
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified. The document mentions "clinically representative conditions" for testing, but no details on the origin (e.g., country) or nature (retrospective/prospective) of the data are provided.
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:
- Adjudication method: 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:
- MRMC study: Not mentioned or implied. The focus is on demonstrating substantial equivalence of the software's capabilities, not on human-in-the-loop performance improvement. The software is described as a "standalone software intended to be used with PET or SPECT hybrid imaging systems in order to manage, process, display and analyze nuclear medical medical image series, to assist in medical diagnosis, to assist in treatment analysis and in therapy response assessment, to assist in the contouring of region of interest for radiotherapy." It assists professionals but there's no mention of a study on how it improves human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document states "PLANET Onco Dose is a standalone software". While it doesn't provide specific isolated algorithm performance metrics (e.g., sensitivity, specificity for a specific task), the "Performance Testing - Bench" section implies that the software's functional and algorithmic performance was evaluated independently to demonstrate its capabilities. However, specific metric-based results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of ground truth: Not specified. The nature of the "performance, functional and algorithmic testing" and "validation activities" would typically involve some form of ground truth for evaluation, but the document does not elaborate on how this ground truth was established or what it comprised.
8. The sample size for the training set:
- Training set sample size: Not specified. The document describes a premarket notification for a software, but does not indicate whether it is an AI/ML model that requires a discrete "training set." If it is, no details are provided.
9. How the ground truth for the training set was established:
- Ground truth establishment: Not specified. (See point 8).
In summary, the provided FDA 510(k) clearance letter and summary primarily focus on establishing substantial equivalence based on intended use and technological characteristics compared to a predicate device. It lacks the detailed reporting of performance studies, including acceptance criteria, specific study design parameters (sample sizes, data provenance, expert involvement for ground truth, adjudication), and results, that would be present in a comprehensive study report or a different type of regulatory submission (e.g., De Novo or PMA for novel devices with specific performance claims).
§ 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).