Search Results

The Retina Workplace is a FORUM application intended for processing and displaying image and optical coherence tomography data. It is also intended for generating reports that contain results from optical coherence tomography and fundus photography.

The Retina Workplace uses CIRRUS algorithms and normative databases as a quantitative tool for the comparison of macular thickness data to a database of normal subjects.

The Retina Workplace is intended to aid trained healthcare professionals in the detection, monitoring and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy and age-related macular degeneration.

The Retina Workplace is a software application to a Class II medical device regulated under 21 CFR §892.2050 and therefore is a Class II medical device. As a software application of the FORUM PACs system (server), the Retina Workplace client is designed to process and display CIRRUSTM HD optical coherence tomography (OCT) data and images provided by Fundus photography.

More specifically, the Retina Workplace processes the retrieved OCT exam data from CIRRUS HD-OCT and CIRRUS Photo images from the FORUM server to display the results of macular thickness analysis (MTA), macular change analysis (MCA), en face Analyses with predefined pre-sets. Advanced RPE Analysis, and raster scans (5 Line. HD 5 Line, 1 Line, HD 1 Line (100x), HD 21 Line, HD Cross, and HD Radial).

The MTA results may be compared against an age-matched population of normal subjects. Analysis and databases comparison is performed by using algorithms and normative databases previously cleared in CIRRUS HD-OCT (K150977) and CIRRUS Photo (K133217) predicate devices. The reports generated by the Retina Workplace can be displayed, printed, and the patient record can be stored back on the FORUM server database.

The Advanced RPE Analysis allows the user to examine the status of the RPE in greater detail than the Macular Thickness Analysis. In particular, Retina Workplace provides two algorithms, one to identify and measure areas of sub-RPE illumination where the OCT is able to penetrate through to the choroid, indicating that the RPE is atrophic (often associated with geographic atrophy), and one to identify and measure elevations in the RPE (often associated with drusen)."

Retina Workplace can automatically register images generated by Fundus photography with other Fundus images e.g. the en face OCT Fundus image when provided in a valid DICOM format and available in the FORUM Archive.

The fundus to fundus registration is part of the predicate devices Cirrus photo (K133217), albeit the function on the predicate device is limited to register image by Fundus photography with en face OCT Fundus images. Retina Workplace version 2.0 extended this functionality to handle LSLO Fundus image. Specifically, to register Fundus image to LSLO Fundus image and LSLO Fundus image to LSLO Fundus image. This registration functionality is used to align HD raster scan pattern to Fundus images, an equivalent function is part of the predicate device CIRRUS photo (K133217). For all performed registrations, the user has the option to register the fundus images manually.

The automatic/manual Fovea registration features (Fovea Finder™ and AutoCenter™) are currently cleared on the CIRRUS™ HD-OCT system (K150977) and CIRRUSTM Photo (K133217) devices and are also included in the Retina Workplace, since version 1.0 (K150467).

The Retina Workplace provides the same overlays as included in the currently cleared CIRRUS HD-OCT system such as:

Introduced with the Retina Workplace Release 2.0

• . En face analyses overlays, with different pre-sets based on the mean / average optical reflectivity values
• . Advanced RPE Analysis overlays with illumination and elevation map
• . Fundus images overlaid with raster scan pattern

Introduced with the previous release of Retina Workplace (Release 1.0, K150467)

• . Fundus image overlay with another Fundus image. (Fundus to Fundus registration)
• . Macular thickness (ILM-RPE) overlay on the Fundus image. (Inner limiting membrane / retinal pigment epithelium)
• Macular change overlay ●
• ETDRS overlay on the Fundus image. (Early Treatment of Diabetic Retinopathy Study) .

Overlays of Retina Workplace not provided by CIRRUS OCT devices:

• MTA thickness map overlaid with raster scan pattern .
• En face analysis overlay with pre-set to create an en face image based on the minimum . optical reflectivity values

The Retina Workplace is a software application intended for processing and displaying image and optical coherence tomography data, generating reports containing results from OCT and fundus photography, and aiding healthcare professionals in the detection, monitoring, and management of ocular diseases.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document does not specify a numerical sample size for the test set used in the "Non-Clinical Validation Test Results." It mentions "representative data (sample data that is representative of clinical cases)."
• Data Provenance: The document explicitly states "sample data that is representative of clinical cases." It does not specify the country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: The document states "Validation of clinical functionalities (Use Case) was completed by ophthalmologists." It does not specify the exact number of ophthalmologists.
• Qualifications of Experts: The experts are identified as "ophthalmologists," implying they are qualified medical professionals specializing in eye care. No further details regarding their years of experience or specific sub-specialties are provided.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method for establishing ground truth for the test set. The clinical validation involved ophthalmologists "executing test cases that simulated the use of the device in a clinical environment and completed questionnaires rating the various aspects of the software." This suggests their assessments were used to evaluate the device's performance, but not necessarily a formal adjudication process for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The study focused on verifying the software's performance against specifications and existing cleared devices, and on the usability and functionality as perceived by ophthalmologists. It did not compare human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, a standalone performance assessment was effectively done for key algorithms and report generation. The document states: "in a direct comparison test, the original OCT test reports generated on the CIRRUS HD-OCT and CIRRUS photo were compared to the reports generated by the Retina Workplace using the same test data, to verify that the results contained in both reports were equivalent." This indicates that the Retina Workplace's algorithms for generating these reports were evaluated independently of human interpretation in this specific test. The Retina Workplace also uses "CIRRUS algorithms and normative databases" which were previously cleared and are implicitly part of standalone algorithm performance.

7. The Type of Ground Truth Used:

• The ground truth for the "direct comparison test" appears to be the results from previously cleared CIRRUS HD-OCT and CIRRUS Photo devices. The aim was to ensure equivalence, meaning these established devices served as the reference.
• For the clinical functionality validation, the "ground truth" was derived from the assessments and feedback of ophthalmologists during simulated clinical use, rating various aspects of the software. This is more akin to an expert consensus/usability evaluation rather than a definitive disease pathology ground truth.

8. The Sample Size for the Training Set:

• The document does not specify a sample size for a training set. This submission is for a software application that largely implements and integrates previously cleared algorithms and normative databases from other devices (CIRRUS HD-OCT, CIRRUS Photo). Therefore, the "training" (if applicable from an AI/machine learning perspective) would have occurred during the development and clearance of those original CIRRUS algorithms and databases, not for the Retina Workplace itself.

9. How the Ground Truth for the Training Set Was Established:

• Since there's no explicit training set mentioned for the Retina Workplace itself, the establishment of ground truth would refer to the processes used for the underlying CIRRUS algorithms and normative databases it utilizes. The document indicates that the Retina Workplace uses "CIRRUS algorithms and normative databases... previously cleared in CIRRUS HD-OCT (K150977) and CIRRUS Photo (K133217) predicate devices." For these previous clearances, the ground truth for their normative databases would typically have been established through a rigorous process involving expert consensus, clinical studies, and potentially pathology or outcome data to define "normal" and characterize various disease states, but the details are not provided in this specific document.

Ask a specific question about this device