(35 days)
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.
§ 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).