(33 days)
FORUM is a software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems through networks.
FORUM is a personal computer software system designed for storage, retrieval, and review of DICOM images, videos and reports originating from ophthalmic instruments and surgical microscopy. FORUM consists of two components: the FORUM Archive and the FORUM Viewer. The FORUM Archive, which contains both a server and client application, provides an archive for storage and administration of medical documents and patient data. The FORUM Viewer is an additional module to the client application which allows images, reports and videos stored in the archive to be reviewed. The FORUM Viewer also includes a modality worklist scheduling function.
When utilized together, the FORUM Archive and Viewer provide a complete workflow cycle from administering patient information via scheduling patients for examinations on connected instruments, through archiving the results of the examinations to retrieval and review of examination data.
Here's an analysis of the provided text regarding the FORUM™ device's acceptance criteria and study information:
The supplied documentation (510(k) summary) for the FORUM™ device does not contain acceptance criteria or detailed study results proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Nidek Advanced Vision Information System (NAVIS)).
The relevant sections state:
- "Evaluation performed on FORUM supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness."
- "Performance testing was conducted on FORUM and was found to perform as intended. FORUM is DICOM compliant according to its DICOM conformance statement."
- "As described in this 510(k) Summary, all testing deemed necessary was conducted on FORUM to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use."
This indicates that internal performance testing was conducted to ensure the device functions as intended and is DICOM compliant, but specific quantitative acceptance criteria and the results of those tests are not disclosed in this summary. The primary "proof" of meeting requirements is established through the argument of substantial equivalence.
Therefore, many of the requested items cannot be extracted from the provided text.
Here is a summary of what can be inferred or explicitly stated based on the provided text, and what is missing:
Acceptance Criteria and Device Performance
The core assertion in the document is that the FORUM™ device performs "as intended" and is "substantially equivalent" to the predicate device. Specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or system response times) and their corresponding reported device performance values are not provided.
| Acceptance Criteria (Not Explicitly Stated/Quantified in document) | Reported Device Performance (as stated in document) |
|---|---|
| Functional equivalence to predicate device (NAVIS) | FORUM™ is "functionally equivalent" to NAVIS. |
| Perform as intended for storing, managing, and displaying data | "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." |
| Safety and Effectiveness (no new questions) | "does not raise new questions regarding safety and effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable, as detailed test set and ground truth establishment are not described. The document pertains to a Picture Archiving and Communications System (PACS) rather than a diagnostic AI algorithm that would typically require expert-established ground truth for performance metrics like accuracy.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable, as detailed test set and ground truth establishment are not 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
- MRMC study: No. This device is a PACS system, not an AI-powered diagnostic tool. The document does not describe any MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable in the context of an AI algorithm. The device itself is a standalone software system for managing and displaying data. The "performance testing" mentioned refers to its functionality as a PACS, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not applicable. For a PACS system, "ground truth" would typically relate to successful storage, retrieval, display of data, and DICOM compliance, generally verified through functional testing and adherence to standards rather than expert clinical diagnoses or pathology.
8. The sample size for the training set
- Sample size for training set: Not applicable. The device is a PACS system, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable, as the device is not an AI model.
§ 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).