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.

Device Description

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.

AI/ML Overview

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:

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.
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.
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.
Adjudication method: Not mentioned.
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.
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.
The sample size for the training set: Not applicable and not mentioned, as the device leverages existing, cleared algorithms.
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).

Summary

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October 24, 2018

Carl Zeiss Meditec, Inc Maria Golovina Sr. Staff Regulatory Affairs Specialist 5160 Hacienda Drive Dublin, CA 94568

Re: K182318

Trade/Device Name: Retina Workplace Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: NFJ, OBO, HKI Dated: August 17, 2018 Received: August 27, 2018

Dear Maria Golovina:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events)

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(21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Alexander Beylin -S 2018.10.24 15:19:44 -04'00' for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182318

Device Name Retina Workplace

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

(as per 21 CFR §807.92)

Retina Workplace

GENERAL INFORMATION

Manufacturer:	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 Jena, Germany+49 (0) 89 909 000-185 (phone)+49 (0) 89 909000-222 (fax)Establishment Registration Number: 9615030
Contact Person:	Maria GolovinaSr. Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, CA 94568(925) 216-2184 Mobile(925) 557-4259 FaxE-mail: maria.golovina@zeiss.com
Date prepared:	October 22, 2018
Device	System, Image Management, Ophthalmic
Classification:	21 CFR 892.2050
Device Class:	II
Product Code:	NFJ
Common Name:	Picture Archiving and Communications System
Trade/Proprietary Name:	Retina Workplace

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The Retina Workplace is intended to be a clinically focused accessory to the FORUM Workplace. The Retina Workplace as described in this premarket notification has a similar intended use, indications for use (specific for the device), and is based on the same fundamental scientific technical characteristics as the predicate devices listed below.

Substantial Equivalence Claimed To (21 CFR §807.92(a)(3))

Predicate Devices	Clearance /Date	Company
The Retina Workplace 2.0 is a clinically focused workplace forretina disorders and is accessory to the FORUM PACS system andis a client of the FORUM PACS server	K170638 / June21, 2017	Carl ZeissMeditec AG
FORUM® is a server based PACS system supporting generic post-processing tools (display, pan, zoom, generating reports, etc.) andinterfaces with DICOM based ophthalmic devices.	K122938 /November 2,2012	Carl ZeissMeditec AG
CIRRUSTM HD-OCT (Version 8) containing algorithms for thedetection and analysis of ophthalmic anatomy, including RetinalNerve Fiber Layer (RNFL), Macular, Optic Nerve Head andGanglion Cell Reference Databases. It provides CIRRUS OCT-Angiography as aid to visualize the vascular structure of the retinaand choroid.	K150977 / June21, 2017	Carl ZeissMeditec AG
CIRRUS™ PhotoCombined fundus camera and OCT system for the imaging,display, storage, and report generation of the fundus images andOCT images.	K133217 /March 19, 2014	Carl ZeissMeditec AG

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INTENDED USE (21 CFR §807.92(a)(5))

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.

INDICATIONS FOR USE (21 CFR §807.92(a)(5))

The Retina Workplace uses CIRRUS algorithms and reference 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 holes, cystoid macular edema, diabetic retinopathy and age-related macular degeneration.

The Retina Workplace (version 2.5) is intended for prescription use only.

DEVICE DESCRIPTION (21 CFR §807.92(a)(4))

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RISK MANAGEMENT AND GENERAL SAFETY AND EFFECTIVENESS

The device labeling contains instructions for use and any necessary caution and notes, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements, and validation of the clinical workflow to ensure that the product meets its intended uses. ZEISS adheres to recognized and established industry practice and relevant international standards where indicated.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE (21 CFR §807.92(a) (6)):

The Substantial Equivalence comparison chart demonstrates the comparison of the technological characteristics of the Retina Workplace to the currently cleared predicate devices.

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Table 1. Technological Comparison Summary Retina Workplace (version 2.5 – K182318) to Retina Workplace (version 2.0 - K170638)

Description	Predicate	Subject
Support for CIRRUS OCT-Angiography	N/A	X
Compatibility with FORUM PACS system	X	X
Processing of clinically focused OCT exam results fromCIRRUS HD-OCT and CIRRUS photo	X	X
Display of exam results in relation to reference data andhave similar workflows	X	X
Use of same algorithms and reference databases toperform evaluations of ophthalmic condition analysis andchange analysis as well as the generation of ETDRS grids	X	X
Registration of images generated by Fundus photographyto OCT fundus images and LSLO fundus imagesgenerated by CIRRUS HD-OCT devices	X	X
Support automatic registration to compensate for thedifferences in scan location during acquisition	X	X
Support of Macular Thickness Analysis, Macular ChangeAnalysis, and Advanced RPE	X	X
Support en face analysis VRI, Mid-Retina, IS/OSEllipsoid, Choroid and Minimum Intensity	X	X
Support retrieve and review HD raster scan patternsprovided by Cirrus HD-OCT devices	X	X
Support the same intended population of trainedhealthcare professionals in the detection, monitoring, andmanagement of ocular diseases	X	X
Support being purchased independently from FORUMPACS system	X	X

Table 2. Technological Comparison Summary Retina Workplace (version 2.5 – K182318) to CIRRUS HD-OCT Version 8.0 - K150977)

Description	Predicate	Subject
Allows the user to perform an en face analysis withMinimum Intensity preset	N/A	X
Allow to register images generated by Fundusphotography to en face OCT fundus images or LSLOfundus images generated by CIRRUS HD-OCT devices	N/A	X
Allow to register LSLO fundus image to LSLO fundusimages generated by CIRRUS HD-OCT devices	N/A	X
Provide the same functionality for processing opticalcoherence tomography (OCT) exam results from CIRRUSHD-OCT	X	X
Support display of these exams results in relation toreference data	X	X
Support using the same algorithms and databases to	X	X

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Image /page/8/Picture/1 description: The image shows the word "ZEISS" in white, block letters against a solid blue background. The font is bold and sans-serif, giving the logo a clean and modern appearance. The letters are evenly spaced and aligned, creating a balanced and symmetrical composition.

perform ILM-RPE thickness and volume evaluations formacular thickness and macular change analyses as well asthe generation of ETDRS grids
Support automatic registration to compensate for thedifferences in scan location during acquisition	X	X
Support use of same algorithms to perform en faceanalysis with presets: VRI, Mid-Retina, IS/OS Ellipsoid,Choroid	X	X
Support use of same algorithms to perform AdvancedRPE Analysis	X	X
Support use of the same algorithm to display the CIRRUSOCT-Angiography exams and – en face visualizations	X	X
Support measurements on fundus images and B-scans	X	X
Support use of the same algorithm to perform the en faceOCT fundus images to en face OCT fundus imageregistration	X	X

Table 3. Technological Comparison Summary Retina Workplace (version 2.5 – K182318) to CIRRUS photo (K133217)

Description	Predicate	Subject
Provide the same functionality for processing opticalcoherence tomography exam results from CIRRUS photo	X	X
Support display of exam results in relation to referencedata	X	X
Support use of same algorithms and databases to performILM-RPE thickness and volume evaluation for macularthickness and macular change analyses as well as thegeneration of ETDRS grids	X	X
Support automatic registration to compensate for thedifferences in scan location during acquisition	X	X
Registration of images generated by Fundus photographyto OCT fundus images	X	X
Registration of HD raster scan pattern with fundus images	X	X
Support measurements on fundus images and B-scans	X	X

Table 4. Technological Comparison Summary Retina Workplace (version 2.5 – K182318) to FORUM (K122938)

Description	Predicate	Subject
Allow the user review CIRRUS HD-OCT and CIRRUSPhoto OCT exam data and perform macular thicknessanalysis, macular changes analysis, en face analysis, andadvanced RPE analysis	N/A	X
Support CIRRUS OCT-Angiography	N/A	X
Enable user to access and display results of CIRRUS HD-OCT (K150977), CIRRUS photo (K133217) stored in aDICOM archive	X	X

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Support display and access fundus images stored in aDICOM archive	X	X
Support the same intended population of trainedhealthcare professionals in the detection, monitoring, andmanagement of ocular diseases	X	X

PERFORMANCE DATA & SUMMARY OF VERIFICATION AND VALIDATION ACTIVITY (21 CFR §807.92(B)):

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 and the device software was found to perform as intended. 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.

All criteria for the verification and validation testing were met; the results demonstrate that the Retina Workplace meets all performance specifications and requirements.

SUBSTANTIAL EQUIVALENCE TO PREDICATES (21 CFR §807.92(B)(1)):

It is the opinion of Carl Zeiss Meditec AG that the Retina Workplace, (version 2.5 - K182318) is substantially equivalent to the primary predicate devices Retina Workplace (version 2.0) (K170638), Cirrus HD-OCT with Software Version 8 (K150977) and to the secondary predicate devices CIRRUS photo (K133217) and FORUM (K122938).

The indications for use for the Retina Workplace are similar to the indications for the predicate devices cited in this application.

A technological comparison and performance data demonstrate that the Retina Workplace (version 2.5 - K182318) is functionally equivalent to the predicate devices, Retina Workplace (version 2.0), Cirrus HD-OCT with Software Version 8 (K150977), CIRRUS photo (K133217), and FORUM (K122938). The differences between the proposed device, the Retina Workplace (version 2.5 - K182318), and the predicate devices are insignificant and do not raise new issues of safety or effectiveness of the device.

The verification and validation activities used to evaluate the Retina Workplace (version 2.5 -K182318), as well as the information and reports provided in this 510(k) submission, do not raise any new issues of safety or effectiveness. Retina Workplace v2.5 performs as well as the predicate devices. Therefore, it is Zeiss's opinion that the safety and effectiveness of the Retina Workplace, (version 2.5 - K182318) when used in accordance with the product labeling, is consistent with and performs as well as, the predicate devices.

510(K) SUMMARY (21 CFR §807.92(C)):

No additional concerns to safety and efficacy have been identified and based upon the comparison of technological features and the performance testing provided in Section 16, the subject Retina Workplace (version 2.5) is substantially equivalent to the predicate Retina Workplace (version 2.0), cleared under K170638.

Regulation Number and Section

§ 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).