(134 days)
FORUM Glaucoma Workplace is a FORUM software application intended for the management, display, and analysis of visual field data. The FORUM Glaucoma Workplace is indicated as an aid to the detection, measurement, and management of progression of visual field loss.
FORUM Glaucoma Workplace is a FORUM software application that provides a means to review and analyze data from various visual field examinations to identify statistically significant and progressive visual field loss. FORUM Glaucoma Workplace utilizes Humphrey® Field Analyzer (HFA) algorithms and databases including STATPAC and Guided Progression Analysis (GPA) to process visual field data and generate visual field reports. GPA compares visual field test results of follow-up tests to an established baseline over time and determines if there is statistically significant change.
The following are the main functionalities of FORUM Glaucoma Workplace:
- . Data retrieval and report storage
- . Managing, analyzing and displaying visual field exams
- Creation of visual field reports .
FORUM Glaucoma Workplace retrieves HFA visual field test data from the FORUM Archive. uses the HFA algorithms and databases to process the visual field raw data, then generates and displays visual field reports. The reports generated by FORUM Glaucoma Workplace are stored as DICOM Encapsulated PDFs in the FORUM Archive.
Here's an analysis of the acceptance criteria and study information for the FORUM Glaucoma Workplace device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative (e.g., sensitivity, specificity, accuracy) acceptance criteria with numerical targets. Instead, the acceptance criteria are generally framed around demonstrating functional equivalence to predicate devices and adherence to design specifications. The performance testing focused on verifying that the device performs as intended and that its generated reports are equivalent to those from predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Management, display, and analysis of visual field data | FORUM Glaucoma Workplace provides management, analysis, and display of visual field exams, creating reports. It utilizes Humphrey® Field Analyzer (HFA) algorithms and databases (STATPAC and GPA) to process visual field data and generate reports. It retrieves HFA visual field test data, processes it, generates and displays reports. The reports contain the same information as previously provided on the HFA instrument and utilize the same algorithms and databases. |
| Functional Equivalence: Detection, measurement, and management of progression of visual field loss (GPA functionality) | FORUM Glaucoma Workplace contains the same GPA algorithms and databases as offered in the Humphrey® Field Analyzer II and II-i. It enables progression analyses, compares follow-up test results to baselines, and determines statistically significant change, providing "Possible Progression" or "Likely Progression" messages consistent with the predicate. It offers the same GPA report types (Full GPA, GPA Summary, GPA Last Three Follow-up, SFA GPA). |
| Report Equivalence: Generated visual field reports (Single Field Analysis, Overview, GPA) match those of predicate devices | The visual field reports (Single Field Analysis, Overview, and Guided Progression Analysis) generated on the HFA II-i were compared to the reports generated by FORUM Glaucoma Workplace using the same test data to verify that the results contained in both reports were equivalent. This comparison was successful. |
| Software Performance: Reliability, stability, and proper operation across supported operating systems | Verification and validation activities, including tests accompanying development (code inspections), module and integration testing, and system verification, were performed. The client and server operating systems were evaluated. Results determined suitability for various Windows client and server operating systems, including Windows XP, Windows 7, Windows Server 2003, and Windows Server 2008 R2. "Verification and validation activities were successfully completed and prove that the product FORUM Glaucoma Workplace meets its requirements and performs as intended." |
| Usability/Clinical Functionality: Meets user requirements in a clinical environment | Validation of clinical functionalities was completed by ophthalmologists using the software with representative data and executing test cases simulating clinical use. They completed questionnaires rating various aspects of the software. (No specific rating results are provided, but the overall conclusion indicates successful completion). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The verification testing involved comparing visual field reports generated on the HFA II-i to reports generated by FORUM Glaucoma Workplace using the same test data. Clinical functionality validation used "representative data (sample data that is representative of true clinical cases)."
- Sample Size for Test Set: Not explicitly stated. The document mentions "the same test data" for report comparison and "representative data" for clinical validation, but no specific number of cases or patients is provided for either.
- Data Provenance:
- For the report comparison: The data originated from the HFA II-i, which is a predicate device.
- For clinical functionality validation: "representative data (sample data that is representative of true clinical cases)". The country of origin of this specific data is not stated or implied. However, the validation participants were ophthalmologists in "two countries."
- Retrospective or Prospective: Not explicitly stated, but the mention of "same test data" and "representative data" suggests it was likely retrospective (pre-existing data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Unclear how many individual ophthalmologists participated in the clinical functionality validation. It states "ophthalmologists in two countries."
- Qualifications of Experts: Ophthalmologists. No specific experience level (e.g., "10 years of experience") is provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. For the report comparison, it states "to verify that the results contained in both reports were equivalent," implying direct comparison. For clinical validation, ophthalmologists "completed questionnaires rating the various aspects of the software," which doesn't suggest a formal adjudication process for establishing a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The submission describes functional equivalence testing and clinical validation, but not a comparative effectiveness study designed to measure human reader performance with and without AI assistance.
- Effect Size: Not applicable, as no MRMC study was conducted.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Was a standalone study done? Yes, implicitly. The core of the "Performance Data" section describes verification that the FORUM Glaucoma Workplace's algorithms and data processing produce results "equivalent" to the predicate HFA II-i algorithms. This involved comparing the outputs of the software (reports) directly against the predicate device's outputs using the "same test data." This is a form of standalone performance assessment, as it focuses on the algorithm's output matching a known, accepted standard.
7. Type of Ground Truth Used
- The ground truth for the comparison of reports and algorithms was based on the outputs and accepted performance of predicate devices (Humphrey® Field Analyzer II and II-i, and their GPA/STATPAC algorithms). Essentially, the "ground truth" was established by the existing, legally marketed and deemed safe/effective predicate technologies.
8. Sample Size for the Training Set
- Not applicable / Not explicitly stated. The FORUM Glaucoma Workplace primarily implements existing, validated HFA algorithms (STATPAC and GPA). The text does not describe a new machine learning algorithm that would require a distinct "training set" in the conventional sense of AI/ML development. It leverages established algorithms and databases.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not explicitly stated. As there's no mention of a new machine learning model being trained by the applicant, the concept of a "training set ground truth" is not relevant in this submission. The algorithms themselves (STATPAC, GPA) were developed and validated years prior by the manufacturer of the Humphrey Field Analyzer.
§ 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).