(53 days)
Illumeo system is an image management system intended to be used by trained professionals, including but not limited to radiologists.
Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
Illumeo is an image management system intended to be used by trained professionals, including but not limited to radiologists.
Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
Illumeo is a medical software system offering a primary interpretation solution for visualization and evaluation a variety of medical images deriving from various imaging modalities as well as non-imaging information. Illumeo interconnects with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
The provided text describes a Special 510(k) submission for the Illumeo system, focusing on its substantial equivalence to a predicate device after minor modifications. It does not contain the specific details about acceptance criteria, device performance, sample sizes, expert qualifications, or MRMC studies that you requested.
The document states that:
- Acceptance Criteria and Device Performance: "Verification and Validation (V&V) activities were performed for proposed Illumeo system and demonstrated that the predetermined acceptance criteria were successfully met." However, it does not describe what those acceptance criteria were nor the specific quantitative results of the device performance against them. It only generally states that the system "Meets the acceptance criteria and is adequate for its intended use and user needs."
- Study Type: Non-clinical verification and validation tests were performed. No clinical studies were required or conducted to support the equivalence for this submission ("Illumeo system did not requires clinical studies to support equivalence.").
- Ground Truth: The document does not discuss ground truth as it would be understood in the context of an AI/ML device relying on diagnostic accuracy, given it's a PACS system subject to a Special 510(k) for modifications.
- Sample Sizes (Test/Training): These details are not provided as no diagnostic performance study was conducted.
- Experts and Adjudication Methods: Not applicable, as there was no diagnostic performance study involving human readers.
- MRMC Comparative Effectiveness Study: Not conducted. The device is a PACS system with improved features, not an AI assisting human readers for a specific diagnostic task.
- Standalone Performance: Not applicable as it's not a standalone diagnostic AI algorithm. It's an image management and viewing system.
Summary of available information:
| Category | Description |
|---|---|
| 1. Acceptance Criteria & Performance | Acceptance Criteria: "predetermined acceptance criteria were successfully met." (Specific criteria not detailed in the provided text). |
| Reported Device Performance: "demonstrated that the design outputs of the modified device meet the design input requirements and do not raise new questions on safety and/or effectiveness." "Meets the acceptance criteria and is adequate for its intended use and user needs." (Specific quantitative performance metrics are not detailed, as this was a Special 510(k) for minor modifications to a PACS system, not a new AI diagnostic device.) | |
| 2. Sample Size (Test) & Data Provenance | Not applicable. No diagnostic performance study involving a test set was conducted. The assessment was based on non-clinical verification and validation of software changes. |
| 3. Number & Qualifications of Experts | Not applicable. No diagnostic performance study requiring expert ground truth establishment was conducted. |
| 4. Adjudication Method | Not applicable. |
| 5. MRMC Comparative Effectiveness Study | No. The device is an image management system (PACS) not a diagnostic AI intended to assist human readers in a comparative effectiveness study. The modifications primarily involve improved system performance, integration, scalability, multimodality support, viewing tools, and UI enhancements. |
| 6. Standalone Performance Study | Not applicable. The Illumeo system is an image management system, not a standalone diagnostic algorithm. Its function is to acquire, store, process, and display images for trained professionals. |
| 7. Type of Ground Truth Used | Not applicable. The evaluation focused on software verification and validation, risk management, and compliance with standards, rather than diagnostic accuracy against a specific ground truth like pathology or outcomes data. |
| 8. Sample Size (Training Set) | Not applicable. The document describes a PACS system for which the concept of a "training set" (as in machine learning) is not relevant in the context presented. The system itself is "trained" in a sense through standard software development and testing cycles to perform its functions, rather than learning from a dataset. |
| 9. Ground Truth for Training Set | Not applicable. |
The study described is a non-clinical verification and validation effort, demonstrating compliance with international and FDA-recognized consensus standards (ISO 14971, IEC 62304, IEC 62366-1, NEMA-PS 3.1-3.20 DICOM, and FDA guidance for software in medical devices). The modifications were deemed "minor technology changes mainly designated to provide users further support in visualization" and did not change the intended use or fundamental scientific technology, hence a Special 510(k) was submitted. The conclusion states that "all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable."
§ 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).