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510(k) Data Aggregation
(218 days)
MYRIAN 1.11
Myrian® is a software medical device aimed at reviewing images produced by all standard medical imaging devices. It also includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. Myrian® can be run from any standard client platform (such as PC) that might be purchased independently by the end user.
Common Users are trained medical professionals, including surgeons, radiologist clinicians and technicians.
This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
Myrian® is a multi modality medical device for the review and analysis of anatomy and pathology in multi-dimensional images acquired from a variety of imaging devices. Myrian provides users with several visualization modes and includes DICOM communication, media interchange (printing, CD burning, storing).
Myrian includes toolsets which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. These toolsets are categorized as follow: Imaging tools, Manual or interactive Objects Of Interest (OOI), Reporting tools, Manual or assisted image alignment tools for multiphase or time-based image comparison, Virtual ROI Cutting Surface tool for preoperative evaluation of surgery strategies, Longitudinal Follow-up tools for oncology workflow.
Myrian® functionalities can be packaged, licensed and marketed as individual modules: XP Lung, XP Lungnodule, XP Liver, XP Vessel, XL Onco.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study methodologies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics for diagnostic accuracy or clinical effectiveness. The submission focuses on internal verification and validation, as well as substantiating equivalence to predicate devices based on functional and technological characteristics.
Instead of a table of numerical acceptance criteria, the document describes a series of internal tests and a literature review to ensure the software fulfills its intended aim with complete safety for the patient and demonstrates Myrian's capability to be used in a clinical environment as intended by the manufacturer. The "Performance data" section outlines the types of internal testing performed.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of a clinical performance study. The stated testing refers to internal software validation.
- Test Set (Clinical): Not applicable, as detailed clinical performance testing with a 'test set' of patient data for diagnostic accuracy is not described.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a clinical test set. The information provided discusses internal software testing, not external validation against expert-derived ground truth.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for establishing ground truth, as no clinical test set with corresponding ground truth establishment is detailed.
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There is no mention of comparing human readers' performance with and without AI assistance, nor any effect size reported.
- MRMC Study Performed: No.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not specify a standalone performance study where the algorithm's performance is measured without human intervention for diagnostic tasks. The "Performance data" section refers to software testing and internal evaluations, not a standalone clinical performance study.
- Standalone Study Performed: Not explicitly detailed as a clinical performance study.
7. Type of Ground Truth Used
Based on the provided information, the primary "ground truth" used for evaluating the device's performance is its adherence to specified software requirements and functionalities through various internal testing phases (pre-integration, functional, integration, regression, build testing). For "clinical features" (e.g., segmentation engines), the document states that a "statistical analysis to apply is defined" and "sample size and relevant inclusion criteria are specified to select the appropriate exams," but it does not explicitly describe the type of clinical ground truth used for these internal evaluations (e.g., pathology, expert consensus, outcomes data).
- Ground Truth Type: Primarily software specification adherence. For certain "clinical features," it refers to "appropriate exams" and "statistical analysis" but lacks specifics on the nature of the clinical ground truth.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. The software mentioned is a medical image review and aided diagnosis software, but the document does not describe it as a machine learning or AI algorithm that would typically require a distinct training set. The descriptions of modules like XP LungNodule mention "Automatic segmentation engine" and "Automatic measurement and characterization," which could imply machine learning, but the document doesn't detail their development or training.
- Training Set Sample Size: Not provided.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described, the method for establishing its ground truth is not mentioned.
- Ground Truth Establishment for Training Set: Not provided.
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(82 days)
MYRIAN 1.4
Myrian is a multi modality medical diagnostic device for the review and analysis of anatomy and pathology in multi-dimensional digital images acquired from a variety of imaging devices. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. Typical end users are trained medical professionals. Myrian includes tools which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. This device is not indicated for mammography use. Lossy compressed mammography-images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
Myrian® with its modules is designed to run on standard PC hardware, through the installed operating system. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user. Myrian is a multi modality medical diagnostic device for the review and analysis of anatomy and pathology in multi-dimensional digital images acquired from a variety of imaging devices. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. Typical end users are trained medical professionals. Myrian includes tools which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. These toolsets are categorised as follow: Enhanced imaging tools such as: Multi-Planar Reformation (MPR) views in any plane (orthogonal, oblique or curved), 3D views in any rendering mode (MIP, MiniP, Average, Volume Rendering). Cross-sectional or Endoscope Exploration Modes along a centerline (e.g. of a vessel, a colon ... etc.). Filet Visualization Mode, to visualize as a flat surface any tubular hollow organ (such as a colon). Manual or interactive Objects Of Interest such as : Annotations of Interest, for information or measurement purposes. Paths (considered as Annotations of Interest). Regions of Interest, for anatomical and pathological structure isolation (such as liver, spleen, lungs, colon ... etc.) through which any measurement can be performed. Points of Interest, for marking areas such as lesions, tumors ... etc. Reporting tools : Objects of Interest generates reports which may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or any other DICOM device. Manual or assisted image alignment tools : for multiphasic or time-based image comparisons. Cutting Surface Tool based on ROI for preoperative evaluation of surgery strategies (such as for the liver). All Myrian functionalities can be packaged, licensed and marketed as individual modules. The Myrian System allows the OEM customization of both the graphical user interface and the available functionalities, while implying no impact on the system performance or system intended use.
The provided text is a 510(k) Summary for the MYRIAN 1.4 image processing system. It describes the device's intended use and general operations but does not contain any specific acceptance criteria or details of a study proving the device meets acceptance criteria.
The document states:
- "Performance data were verified versus the requirements of the FDA 'Guidance of the Content of Pre Market Submissions for Software Contained in Medical Devices'"
- "User Site Testing and Benchmarking demonstrate that MYRIAN meet the required specifications. No adverse affects have been detected."
However, it does not provide any actual performance data, specific acceptance criteria, or details of the mentioned "User Site Testing and Benchmarking" study. Therefore, I cannot extract the requested information.
To answer your request, the input text would need to include a section detailing:
- Specific numerical acceptance criteria (e.g., accuracy, precision, processing speed thresholds).
- The measured performance of the device against those criteria.
- Details about the study design, sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, and whether it was a standalone or comparative effectiveness study.
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(35 days)
MYRIAN
Myrian is a multi modality medical diagnostic device. It is aimed at reviewing and analysing anatomy and pathology. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. It provides user a set of tools meant to create and modify volumes of interest. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
Myrian® system is a software suite providing the following services : Import of DICOM images from any DICOM modality, workstation or PACS Visualization of DICOM images in thin MPR, thick MPR and full 3D volume rendering Creation of VOI (Volume Of Interest) with dedicated tools Calculation of volumes, surface and of average, minimum and maximum densities of VOI Follow-up of patient examination Generation of medical reports Export of DICOM images to any format, DICOM entity or media
Here's an analysis of the provided text regarding the Intrasense MYRIAN device:
Analysis of Intrasense MYRIAN Device Performance and Study
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria and corresponding reported device performance metrics are not explicitly stated. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to general software safety guidelines.
| Acceptance Criteria Category | Acceptance Criteria (As stated or inferred) | Reported Device Performance (As stated or inferred) |
|---|---|---|
| General Compliance | Requirements of FDA "Guidance of the Content of Pre Market Submissions for Software Contained in Medical Devices" | MYRIAN meets the required specifications. |
| Adverse Effects | No adverse effects detected. | No adverse effects have been detected. |
| Feature Functionality | All described functionalities (Image import, Visualization, VOI creation, Calculation, Follow-up, Reporting, Export) operate as intended. | User Site Testing and Benchmarking demonstrate MYRIAN meets required specifications. Implied successful operation of features. |
| Safety and Effectiveness | Substantially equivalent to predicate devices in terms of safety and effectiveness. | The technological characteristics, features, specifications, materials, mode of operation, and intended use of MYRIAN device are equivalent to those of the predicate devices. Differences do not raise new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "User Site Testing, Benchmarking and clinical data analysis" for performance verification. However, no specific sample sizes for the test set or details about data provenance (e.g., country of origin, retrospective/prospective nature) are provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. It states that "Typical users of Myrian® with its Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians," and that images, "When interpreted by a trained physician, filmed or displayed images on the Myrian® and its Modules may be used as a basis for diagnosis." This implies that medical professionals would be involved in evaluating the device, but no details on ground truth establishment are given.
4. Adjudication Method
The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There is no mention of comparing human readers with and without AI assistance or any effect size of improvement. The device description and performance data focus on its standalone functionality and equivalence to predicate devices.
6. Standalone (Algorithm Only) Performance Study
The document implies that the device's performance was evaluated in various settings, stating "User Site Testing, Benchmarking and clinical data analysis demonstrate that MYRIAN meet the required specifications." This suggests that the algorithm and its features were tested for their intended functionality, which aligns with standalone performance evaluation. However, specific metrics of "algorithm-only" performance (like sensitivity, specificity, accuracy for a particular task) are not provided. The focus is on the software suite's general functionality for image processing, visualization, and measurement.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). While it mentions that images interpreted by a trained physician may be used for diagnosis, it doesn't describe how ground truth was established for the purpose of validating the device's performance.
8. Sample Size for the Training Set
The document does not specify the sample size used for any training set. Given the submission date (2007) and the description of the device (a software suite for general image processing and visualization), it's highly likely that this device does not utilize deep learning or other machine learning algorithms that require explicit "training sets" in the modern sense. It appears to be a rule-based or conventional image processing software.
9. How Ground Truth for the Training Set Was Established
As there's no mention of a training set, the document does not describe how ground truth for a training set was established.
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