(134 days)
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No
The description explicitly states the use of existing, well-established algorithms (STATPAC and GPA) from the predicate device (Humphrey Field Analyzer). There is no mention of AI, ML, or any learning-based approach. The analysis is based on statistical comparisons of visual field data over time using these predefined algorithms.
No
The device is described as an aid for detection, measurement, and management of visual field loss, and processes visual field data to generate reports, rather than directly treating a condition.
Yes
Explanation: The device is indicated as an "aid to the detection, measurement, and management of progression of visual field loss," which directly contributes to a diagnosis or monitoring of a medical condition. It processes and analyzes visual field data using algorithms to create reports that identify statistically significant and progressive visual field loss, assisting healthcare professionals in diagnosis and management.
Yes
The device is described as a "FORUM software application" and its functionalities are solely related to the processing, analysis, and display of visual field data. While it interacts with data from a hardware device (Humphrey Field Analyzer), the device itself is presented as a software application running on a computer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The FORUM Glaucoma Workplace processes and analyzes visual field data obtained from a Humphrey Field Analyzer (HFA). This data is generated by a test that assesses a patient's peripheral vision, not by analyzing a biological sample taken from the body.
- Intended Use: The intended use is for the management, display, and analysis of visual field data to aid in the detection, measurement, and management of progression of visual field loss. This is related to the function of the eye and vision, not the analysis of biological samples.
The device is a software application that processes data from a diagnostic instrument (the HFA), but it does not perform the diagnostic test itself on a biological sample.
N/A
Intended Use / Indications for Use
FORUM Glaucoma Workplace is a FORUM software application intended for the management, display, and analysis of visual field data.
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.
Product codes (comma separated list FDA assigned to the subject device)
NFJ, HPT
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on FORUM Glaucoma Workplace and it was found to perform as intended. Each function and/or feature was tested by means of an appropriate test case or test specification. The verification testing demonstrates that the device performance complies with specifications and requirements identified for FORUM Glaucoma Workplace.
Verification and validation was conducted to ensure that the medical device meets the product and user requirements and to support a determination of substantial equivalence to the predicate devices.
The software verification activities were divided into three phases:
- Tests accompanying development (including code inspections) .
- Module and integration test phase stabilization phase .
- System verification .
As part of the verification testing, 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.
The client and server operating systems were also evaluated during verification. The results determined that FORUM Glaucoma Workplace is suitable for the same client operating systems for which the respective FORUM Archive & Viewer client version is released and that it is suitable under the following server operating systems:
- Windows XP (32 bit) with Service Pack 3 .
- Windows 7 (32 or 64 bit) with Service Pack 1 .
- Windows Server 2003 (32 bit) with Service Pack 2 .
- Windows Server 2008 (TS) R2 (64 bit) with Service Pack 1 .
Validation of clinical functionalities was completed by ophthalmologists in two countries using FORUM Glaucoma Workplace software as well as representative data (sample data that is representative of true clinical cases) installed on a computer. The validation participants executed test cases that simulated the use of the device in a clinical environment and completed questionnaires rating the various aspects of the software.
Verification and validation activities were successfully completed and prove that the product FORUM Glaucoma Workplace meets its requirements and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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510(k) Premarket Notification FORUM Glaucoma Workplace
SECTION 5.
510(K) SUMMARY
5. 510(K) SUMMARY
510(k) SUMMARY (per 21 CFR §807.92)
FORUM Glaucoma Workplace
JUL 2 3 2013
GENERAL INFORMATION
| Manufacturer: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
D-07745 Jena, Germany
+49 3641220-667 (phone)
+49 3641220-282 (fax)
Establishment Registration Number: 9615030 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mandy Ambrecht
Staff Regulatory Affairs Specialist
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
(925) 557-4561 Phone
(925) 557-4259 Fax
E-mail: mandy.ambrecht@zeiss.com |
| Date prepared: | July 12, 2013 |
| Device | System, Image Management, Ophthalmic |
| Classification: | 21 CFR 892.2050
21 CFR 886.1605 |
| Device Class: | II |
| Product Code: | NFJ
HPT |
| Common Name: | Picture Archiving and Communications System |
| Trade/Proprietary Name: | FORUM Glaucoma Workplace |
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510(K) SUMMARY
PREDICATE DEVICES:
| Company: | Carl Zeiss Meditec AG |
|---|---|
| Device: | FORUM |
| (K122938) | |
| Company: | Carl Zeiss Meditec, Inc. |
| Device: | Guided Progression Analysis (GPA) for the Humphrey |
| Field Analyzer II and II-i series | |
| (K093213) |
INTENDED USE
FORUM Glaucoma Workplace is a FORUM software application intended for the management, display, and analysis of visual field data.
INDICATIONS FOR USE
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.
DEVICE DESCRIPTION
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.
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510(K) SUMMARY
FORUM Glaucoma Workplace displays interactive screens and the generated visual field reports. These reports include those previously offered by the HFA II and HFA II ->: Single Field Analysis; Overview; Guided Progression Analysis (GPA) Summary, Full GPA, GPA Last Three Follow-up and Single Field Analysis (SFA) GPA.
After launching FORUM Glaucoma Workplace from the FORUM application, two tabs are presented: Overview and GPA.
Overview Tab
FORUM Glaucoma Workplace creates and displays visual field reports for visual field tests provided the visual field examination results have been stored in FORUM. These reports include the Overview and Single Field Analysis report which previously could only be created on the Humphrev Field Analyzer II or II-i instrument. The Overview report contains the data of all existing tests selected. The Single Field Analysis report contains data from a single central threshold test. The reports generated by FORUM Glaucoma Workplace contain the same information as previously provided on the HFA instrument and utilize the same algorithms and databases.
Interactive Features
The main interactive functionalities available in the Overview tab are as follows:
Right-clicking on an exam
Right-clicking on an exam displayed in the Overview presents a context menu offering the option to "Show SFA Report" or "Enter IOP".
Double-clicking on an exam
Double-clicking on an exam displayed in the Overview presents a Single Field Analysis (SFA) report of the individual exam.
GPA Tab
FORUM Glaucoma Workplace contains the same GPA algorithms and databases as offered in the Humphrey® Field Analyzer II and II-i and allows GPA to be performed on a computer running FORUM independent of and apart from the visual field instrument itself. Within the GPA tab, GPA information is provided on interactive screens.
The GPA makes it possible to undertake progression analyses of ongoing exam data. The results of the Progression Analysis and the exams thev are based on are shown under the GPA tab. All of the patient's suitable data that are stored in FORUM are available for analysis. Each analysis can be saved as a report in PDF form.
GPA analysis can be performed for any patient who has at least two baseline visual field tests. These tests must have been performed with the Full Threshold, Swedish Interactive Threshold
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510(K) SUMMARY
Algorithm (SITA) Standard, or SITA Fast test strategies. Also, at least one follow-up visual field test must have been performed using either the SITA Standard or SITA Fast test strategy.
FORUM Glaucoma Workplace provides GPA that can compare the established baseline with up to 98 follow-up tests and determine whether there is statistically significant change. GPA highlights any changes from the baseline that represent larger than the expected clinical variability. In addition, it provides messages such as "Possible Progression" or "Likely Progression" when the changes show consistent and statistically significant loss. Progression is a statistically significant change that is also clinically repeatable and consistent. A statistically significant change from baseline in the same three or more points in two consecutive follow-up tests will result in a message on the report indicating "Possible Progression". The same scenario but in three consecutive follow-up tests will result in a message on the report indicating "Likely Progression".
From the GPA tab. users can create four types of GPA reports: Full GPA, GPA Summary, GPA Last Three Follow-up and Single Field Analysis (SFA) GPA. A Single Field Analysis report can also be created within the GPA tab. The same elements are utilized as with GPA on the Humphrev Field Analyzer II and II-i, however, within FORUM Glaucoma Workplace, some of the symbols and text on the screens and printouts are in color rather than in black and white.
FORUM Glaucoma Workplace allows the user to interact with the available data. When viewing the GPA on the screen, the user can.hold the mouse pointer over a particular area and a small tooltip will appear with details regarding the particular test. The tooltip provides information such as the test date, test pattern and strategy.
Representation of the Data and Results
Visual Field Plots:
Threshold Plot
The threshold plot presents the measurement results in numerical (decibel) form.
Graytone Plot
The gravtone representation of the patient's visual field provides an immediate idea of the size and depth of any field defects present. Each variation of the pattern corresponds to a 5 dB change in sensitivity.
Total Deviation Plot
The Total Deviation Plots reflect the total deviation of the threshold values at every test point.
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Pattern Deviation Plot
Pattern Deviation is represented in the same format as the Total Deviation Plot, with adjusted STATPAC analysis of the test results.
Reliability Indices
The following Reliability Indices are indices used in the visual field reports:
- Fixation Loss (FL) .
- False Negative errors (FN) .
- False Positive errors (FP) .
The fixation loss is presented as a fraction of the total fixation loss over the total of the stimuli present in the blind spot. For the Swedish Interactive Threshold Algorithm (SITA) Standard and SITA Fast testing strategies, the false negative and false positive errors are presented in percent. For Full Threshold and FastPac tests, false positive errors, false negative errors, and fixation losses are all printed as a ratio. The false positive and false negative results will appear as a fraction (i.e., total number of false positive errors divided by the total number of trials).
Global Indices
The following Global Indices are presented in the visual field reports:
- MD Mean Deviation .
- PSD Pattern Standard Deviation .
- VFI Visual Field Index .
MD and PSD indices are provided in numerical values in decibels (dB). The Mean Deviation is the average elevation or depression of the patient's overall field compared to the normal reference field. The Pattern Standard Deviation is a measure of the degree to which the shape of the patient's measured field departs from the normal, age adjusted reference field. The Visual Field Index is a measure of the patient's overall visual function as compared to an age adjusted normal population. The VFI is presented as a percentage.
The last index, the Glaucoma Hemifield Test (GHT), is also presented on the visual field report for tests completed using the 24-2 or 30-2 test pattern. The Glaucoma Hemifield Test (GHT) evaluates five zones in the superior field and compares these zones to their mirrored zones in the inferior field. The GHT evaluates the severity of disturbed points in each zone pair, relative to its normative database, and shows a message such as: Within Normal Limits; Outside Normal Limits or Borderline.
GPA Plots:
Deviation from Baseline Plot
The Deviation from Baseline Plot is a graph presented in numerical values measured in decibels
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510(K) SUMMARY
(dB) similar to the Total and Pattern Deviation Plots. This plot compares the pattern deviation values of the follow-up test to the pattern deviation values of the average of the two baseline tests.
Progression Analysis Probability Plot
The Progression Analysis Probability Plot gives the statistical significance of the decibel changes shown in the Deviation from Baseline Plot. It compares the changes between the Baseline and Follow-up exams to the inter-test variability typical of stable glaucoma patients and then shows a plot of point locations which have statistically changed.
Global Indices
The same global indices available on other visual field results (Mean Deviation (MD), Pattern Standard Deviation (PSD), and Visual Field Index (VFI) are presented on the GPA results.
GPA Alert
The GPA Alert allows the user to recognize possible deterioration in consecutive tests. The alerts that are displayed include "Possible Progression" and "Likely Progression". When there are three or more points that show statistically significant deterioration in at least two consecutive tests, the progression analysis indicates "Possible Progression". In the same scenario but with at least three consecutive tests, then the progression analysis alert indicates "Likely Progression".
Visual Field Index
The Visual Field Index is a measure of the patient's overall visual function as compared to an age adjusted normal population. The VFI is presented as a percentage.
VFI Plot
The VFI Plot is a trend plot that shows a linear regression analysis of the VFI for all exams included in the analysis over time. The VFI values for all exams are graphically presented as a function of the patient's age. The open square symbols represent VFI values from the Full Threshold exams whereas the filled square symbols represent VFI values from SITA exams.
VFI Bar
The VFI Bar is a histogram that provides a graphical representation of the patient's current VFI value. A two to five year projection of the VFI regression line is also shown.
Image /page/5/Figure/16 description: The image shows a graph with the rate of progression on the x-axis and percentage on the y-axis. A linear regression line is plotted on the graph, along with a projection line. The graph also includes VFI cutoff lines and a significance limit region. The rate of progression is -1.6 ± 4.1%/year (95% confidence).
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510(k) Premarket Notification
FORUM Glaucoma Workplace
SECTION 5.
The VFI plot contains the following symbols:
| Test Strategy:
Full Threshold | Test Strategy:
SITA Standard
or SITA Fast | Meaning |
|------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image: Full Threshold Test Strategy | Image: SITA Standard or SITA Fast Test Strategy | Test defined as baseline for the Progression Analysis
(Baseline exam). The test results are graphically
displayed above the VFI plot. |
| Image: Full Threshold Test Strategy red | Image: SITA Standard or SITA Fast Test Strategy red | Test defined as Baseline for the Progression Analysis
(Baseline exam). When the results of the earliest
selected Baseline test [independent of the user's input
(automatically or manually selected)] shows a
significant learning effect, the test appears in red in
the VFI Plot in the monitor display.
The red shading indicates that a learning effect has
occurred.. If a test is designated to be the first
baseline test, but its VFI value is so low that it falls
below the p $