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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:

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.

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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:

• 3D liver-lung shunt assessment;

• Local Deposition Model;

• Voxel S Value approach based on the schema in MIRD Pamphlet 17 [1]:

• Dosimetry based on 90Y-microspheres-PET (or SPECT Bremsstrahlung) series;

• 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).

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