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The Retina Workplace is a FORUM application intended for processing and displaying fundus 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. It supports the processing and displaying of CIRRUS OCT-Angiography data, which is indicated as an aid in the visualization of vascular structures of the retina and choroid.

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 edema, diabetic retinopathy and age-related macular degeneration.

The Retina Workplace is designed in conjunction with the FORUM PACS system, which support clinically focused client workplaces to aid the optometric and ophthalmology clinicians with the processing, display, review, management, and storage of digital data contained in patient records. The Retina Workplace is software application of FORUM Archive and Viewer PACs workplace. FORUM is a software system designed for storage, processing, and review of images, videos, and reports originating from computerized diagnostic instruments or electronic documentation systems over a network. The Retina Workplace is connected to the FORUM server via an internal interface. The Retina Workplace retrieves CIRRUS OCT exam data and fundus images from the FORUM server. The Retina Workplace is intended to support the physician with a clinically focused workplace for the retina by using the imported OCT exam data from CIRRUS HD-OCT and CIRRUS Photo to report and display the results.

The Retina Workplace (version 2.5) is the latest generation device in the Retina Workplace series. The version of the 2.5 that is the subject of this submission is a modified version of the Retina Workplace (version 2.0) cleared under K170638.

Like its predecessors, Retina Workplace version 2.5 is designed to process and display CIRRUS OCT exams by using the algorithms and databases that are currently in use on the FDA cleared CIRRUS HD-OCT version 8 (K150977) and CIRRUS Photo (K133217). The CIRRUS HD-OCT OCT-Angiography was also cleared in K150977.

The provided text describes the Retina Workplace device and its substantial equivalence to predicate devices, but it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

The document is a 510(k) summary for a medical device cleared by the FDA, which generally focuses on demonstrating substantial equivalence to existing devices rather than presenting the full details of a clinical performance study with specific acceptance criteria, sample sizes, and expert adjudication as you've requested.

Here's what can be extracted and what is missing:

What is present/can be inferred:

• Device Performance: The document generally states that "All criteria for the verification and validation testing were met; the results demonstrate that the Retina Workplace meets all performance specifications and requirements." and "Retina Workplace v2.5 performs as well as the predicate devices." However, it does not specify what those performance specifications and requirements (acceptance criteria) were.
• Study type: "Software testing was conducted to establish the ability of the subject Retina Workplace (version 2.5 - K182318) to meet design and customer requirements. Verification and validation activities for the Retina Workplace were conducted... The system verification test report provides the test cases, expected results for each test case and the actual results obtained. Validation testing was conducted to ensure that the device meets the customer's requirements with respect to performance." This indicates that verification and validation (V&V) testing was performed, typical for software devices, rather than a prospective clinical trial. It sounds more like functional and performance testing against internal specifications.
• Human-in-the-loop/Standalone: The device is intended "to aid trained healthcare professionals," suggesting a human-in-the-loop context. No information on standalone algorithm performance is provided.
• Ground Truth: The document states "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." This implies that existing, cleared algorithms and normative databases from the predicate devices (CIRRUS HD-OCT) are leveraged as the "ground truth" or reference for quantitative measurements.
• Training Set (Inferred): Since the device uses "CIRRUS algorithms and reference databases" that are already "currently in use on the FDA cleared CIRRUS HD-OCT version 8 (K150977) and CIRRUS Photo (K133217)", it suggests that the training of these core algorithms would have occurred as part of the predicate device development. No specific "training set" for the Retina Workplace v2.5 itself (as a new algorithm being trained) is mentioned, as its primary function is processing and displaying data using existing cleared algorithms.

What is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: The specific criteria (e.g., sensitivity, specificity, accuracy targets, imaging quality metrics) are not listed. Only a general statement that "all criteria... were met" is provided.
2. Sample size used for the test set and the data provenance: No details on the number of cases or patients used in the verification and validation (V&V) testing, nor the origin (country, retrospective/prospective) of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As this appears to be software/functional V&V rather than a clinical reader study, expert ground truth establishment for a test set in the way you describe is not explicitly mentioned. If the V&V largely relies on output comparison to predicate devices or established algorithms, then the "ground truth" might be the output of those validated predicate systems.
4. Adjudication method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned. The focus is on the device using existing, cleared algorithms, not on how human readers perform with or without its assistance.
6. Standalone performance: While the device leverages algorithms, no specific standalone performance metrics (e.g., diagnostic accuracy of an automated detection) for the Retina Workplace itself are presented, implying it's an "aid" rather than a fully autonomous diagnostic tool.
7. The sample size for the training set: Not applicable and not mentioned, as the device leverages existing, cleared algorithms.
8. How the ground truth for the training set was established: Not applicable and not mentioned, as the device leverages existing, cleared algorithms.

Conclusion based on the provided text:

The document describes the Retina Workplace (version 2.5) as a software application that integrates and processes data using algorithms and databases already cleared and present in predicate devices (CIRRUS HD-OCT and CIRRUS Photo). The "study" proving it meets acceptance criteria appears to be a software verification and validation (V&V) process, ensuring that the new version correctly implements and displays the functionalities of the existing, cleared algorithms and processes data as intended. It does not appear to involve a new clinical performance study with human readers, novel algorithm training, or the establishment of new, independent ground truth for a diagnostic AI. The acceptance criteria were internal performance specifications for the software, which were reportedly met.

To get the detailed information you're asking for, one would need to refer to the full 510(k) submission (if publicly available beyond this summary) or documentation from the predicate devices (K150977 for CIRRUS HD-OCT version 8 and K133217 for CIRRUS Photo).

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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.

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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 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), and 5 line raster analysis. The 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 (K111157) and CIRRUS Photo (K112184) 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.

In addition, Retina Workplace can automatically register images generated by Fundus photography with the OCT cube image when provided in a valid DICOM format, including the necessary pixel spacing. Additionally, the user has the option to register the fundus / OCT images manually. The automatic/manual image registration features (Fovea Finder™ and AutoCenter™) are currently cleared on the CIRRUS™ HD-OCT system (K111157) and CIRRUSTM Photo (K112184) devices.

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

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

The provided text describes the Retina Workplace, a software application that processes and displays image and optical coherence tomography data, and generates reports. It also indicates that the device has undergone verification and validation testing to ensure it meets acceptance criteria.

However, the document does not contain a detailed table of specific acceptance criteria or quantitative performance metrics for the device itself. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to internal software development and risk management processes.

Therefore, many of the requested details, particularly quantitative performance metrics and specific study designs for proving those metrics, are not present in the provided text.

Here's a breakdown of the information that can be extracted and the information that is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This specific table, with quantitative acceptance criteria and corresponding performance metrics, is not explicitly provided in the document. The document states that "software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria" and that "Verification and validation activities met their acceptance criteria successfully and proved that the product, the Retina Workplace, meets its requirements and intended uses." However, the exact thresholds and measured performance values are not detailed.

General statements on performance found in the document:

• "Verification and validation testing was performed to evaluate the performance and functionality of the software and the device has been found to perform as intended."
• "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." (Implies an acceptance criterion of "equivalence" in report generation.)
• The device "does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate and reference devices."

Regarding the study that proves the device meets acceptance criteria:

The study referenced is primarily a non-clinical validation test and software bench testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test set sample size: "representative data (sample data that is representative of clinical cases)" was used, but the exact sample size (number of cases or images) is not specified.
• Data provenance: "sample data that is representative of clinical cases" is mentioned, but the country of origin of the data or whether it was retrospective or prospective is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: "Validation of clinical functionalities (Use Case) was completed by ophthalmologists". The exact number of ophthalmologists is not specified.
• Qualifications of experts: The experts are identified as "ophthalmologists". Specific details such as "10 years of experience" are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• The document states that ophthalmologists "executed 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 feedback was used to validate functionality. However, a formal adjudication method like "2+1" or "3+1" for reaching a consensus on ground truth or performance assessment is not described. It appears to be an assessment by the ophthalmologists, but how disagreements or variations in their ratings were handled is not detailed.

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 MRMC comparative effectiveness study involving AI assistance for human readers is described. The study focused on validating the software's functionality and equivalence to existing cleared functionalities. The Retina Workplace itself is positioned as an accessory to a PACS system, providing tools and algorithms (CIRRUS algorithms and normative databases, which were previously cleared). The document does not describe studies where human readers are observed using the Retina Workplace to see an improvement in their diagnostic performance. Therefore, an effect size of human improvement with AI assistance is not provided.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• The Retina Workplace is described as a "software application" that "processes and displays image and optical coherence tomography data" and "uses CIRRUS™ algorithms and normative databases as quantitative tool for the comparison of macular thickness data to a database of normal subjects."
• "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 suggests a standalone evaluation of its report generation function against established methods.
• 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), and 5 line raster analysis." It specifically states that "The MTA, MCA, and 5 line raster analysis software applications and normative databases remain unchanged from the currently cleared versions in the CIRRUS HD-OCT and CIRRUS Photo products." This implies that the core algorithms' standalone performance was previously established during the clearance of the predicate CIRRUS devices and is not re-evaluated for this submission, as they are being reused without change.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the "direct comparison test" of report generation, the "original OCT test reports generated on the CIRRUS HD-OCT and CIRRUS photo" served as the reference or ground truth for equivalence. These predicate devices' reports are assumed to be "true" or at least the standard for output.
• For the validation of clinical functionalities by ophthalmologists, their assessment based on their expertise ("completed questionnaires rating the various aspects of the software") served as a form of expert assessment/consensus on the software's usability and fulfillment of clinical needs.

8. The sample size for the training set

• The document describes the Retina Workplace as using "CIRRUS™ algorithms and normative databases". It explicitly states, "The MTA, MCA, and 5 line raster analysis software applications and normative databases remain unchanged from the currently cleared versions in the CIRRUS HD-OCT and CIRRUS Photo products." This means the normative databases and algorithms were trained and established previously during the clearance of the predicate devices (K111157 and K112184). The training set and its size for those original algorithms/databases are not provided in this document (K150467). This submission focuses on the integration and display of results from these pre-existing algorithms.

9. How the ground truth for the training set was established

• As mentioned above, the core algorithms and normative databases pre-exist from predicate devices. How their ground truth was established for their original training is not detailed in this K150467 summary. It's implied that this was handled in the previous clearances (K111157 and K112184).

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