(39 days)
FORUM is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications.
FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.
FORUM is a computer software system designed for storage, processing, and review of images, videos and reports originating from computerized diagnostic instruments or other documentation systems.
FORUM is available in two different product variants: FORUM Archive and FORUM Archive & Viewer.
The FORUM Archive consists of a server and a client application. The server offers a DICOM interface to diagnostic instruments via a network. On this server, medical documents including reports, images, videos or raw data and patient data are archived. All data can be retrieved via the network by instruments or other applications using the DICOM interface. The client application provides a graphical user interface (GUI) for administering the server and the data stored therein.
FORUM Viewer serves as an additional module to the client application that allows health care professionals to display and review the data stored in FORUM Archive. FORUM Viewer enables health care professionals to perform measurements in fundus images, based on the scaling information which is provided in the DICOM header and add comments to the saved data. FORUM Viewer provides the option for data transfer to and from other FORUM installations and the ability to import non-DICOM data. FORUM Viewer also includes a modality worklist (scheduling).
The provided text is a 510(k) summary for the FORUM™ software system. It describes the device's intended use, comparison to predicate devices, and indicates that performance testing was conducted. However, it does not contain the specific details required to answer all parts of your request about acceptance criteria and a study proving those criteria.
The document makes general statements about performance but lacks the quantitative data, study design, and specifics typically found in a detailed performance evaluation section.
Here's a breakdown of what can and cannot be answered based only on the provided text:
1. A table of acceptance criteria and the reported device performance
Cannot be fully extracted.
The document states: "Performance testing was conducted on FORUM and was found to perform as intended. FORUM is DICOM compliant according to its DICOM conformance statement."
This is a general statement and does not provide specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or quantitative measurement error thresholds) or reported device performance metrics against those criteria. The only specific performance claim is DICOM compliance.
2. Sample size used for the test set and the data provenance
Cannot be extracted.
The document does not mention a "test set" in the context of device performance, nor does it provide any sample sizes or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Cannot be extracted.
Since no specific test set or ground truth establishment process is described beyond general "performance testing," this information is not available.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Cannot be extracted.
No adjudication method is described.
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
No.
The document describes a software system for image management, display, and measurement. It is not an AI-powered diagnostic device in the sense of directly assisting human readers in interpreting images or providing diagnostic output that would necessitate an MRMC study to compare human performance with and without AI assistance. The "FORUM ASSIST match" accessory software is mentioned for identifying potential duplicates, but no performance study for this specific feature or human improvement is detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Partially applicable, but without metrics.
The device is described as a software system performing functions like storage, processing, display, and measurement (specifically, line measurement in fundus images). The text states, "The line measurement function in FORUM has been verified and validated and the results indicate that the difference does not raise new questions of safety and effectiveness." This implies standalone verification of the measurement function, but no specific performance metrics or acceptance criteria for this measurement are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Cannot be extracted definitively.
For the mention of the "line measurement function," it's implied that some form of ground truth was used for verification and validation, but the type of ground truth (e.g., comparison to manual measurements by experts, a physical phantom, etc.) is not specified.
8. The sample size for the training set
N/A (Not Applicable in the traditional AI sense).
This is not an AI/ML device in the context of supervised learning requiring a "training set." It's a software system for image management and measurement. Therefore, the concept of a training set as typically understood for AI algorithms does not apply.
9. How the ground truth for the training set was established
N/A. As above, no training set is described.
Summary of what is present regarding performance:
- General Statement: "Performance testing was conducted on FORUM and was found to perform as intended."
- DICOM Compliance: "FORUM is DICOM compliant according to its DICOM conformance statement."
- Line Measurement Function: "The line measurement function in FORUM has been verified and validated and the results indicate that the difference does not raise new questions of safety and effectiveness." This points to a specific function being tested, but without details on how or to what standard.
- HL7 Standard: The HL7 interface for EMR integration "has been verified with FORUM and the results indicate that the difference does not raise new questions of safety and effectiveness." This confirms testing for an interface standard.
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on functional characteristics and high-level claims of performance testing and compliance with standards (DICOM, HL7). It does not provide detailed clinical study results, specific acceptance criteria, or quantitative performance metrics as would be found for a device requiring more rigorous clinical or algorithmic performance evaluation (e.g., an AI diagnostic aid). This is typical for a device like an image management system where the primary concern is proper data handling, display, and adherence to communication standards rather than diagnostic accuracy.
§ 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).