(284 days)
FORUM is a software system intended for use in management, processing of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications (including but not limited to Retina Workplace, Glaucoma Workplace).
FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.
FORUM and its accessories are a computer software system designed for management, processing, and display of patient diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications.
FORUM receives data via DICOM protocol from a variety of ophthalmic diagnostic instruments (such as CIRRUS, CLARUS, and 3rd Party systems), allows central data storage and remote access to patient data. This version of FORUM allows the user to access their data in the cloud via ZEISS developed non-medical device accessories. FORUM is an ophthalmic data management solution. FORUM provides basic viewing functionalities and is able to connect all DICOM compliant instruments.
This version of FORUM provides additional device functions such as review and annotation functionality of fundus images/movies, display of OCT image stacks, bidirectional data exchange between FORUM Workplaces, customization of document viewing abilities, user interface improvements, and user management updates.
This version of FORUM has additional non-medical device functions that are performed by non-medical device accessories, such as documentation storage, export of data in various formats, export to the cloud, improved IT integration capability into the existing IT network, image sorting, EMR log in improvements, numerous backend improvements with the purpose of streamlining clinical workflow.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device:
Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It usually doesn't contain a detailed breakdown of a separate clinical study with acceptance criteria, sample sizes, and expert adjudication in the same way an AI/ML device would. Instead, it relies on extensive software verification and validation to demonstrate safety and effectiveness.
Based on the provided text, a direct answer to all your questions in the typical format for a clinical study is not explicitly available for this specific type of device (a medical image management and processing system). However, I can extract the relevant information and infer what's implied.
Acceptance Criteria and Device Performance Study for FORUM (K213527)
This submission for FORUM (K213527) is a 510(k) Pre-market Notification for a medical image management and processing system. The acceptance criteria and "study" are primarily focused on demonstrating substantial equivalence to a predicate device (FORUM Archive and Viewer, K122938) through software verification and validation, rather than a traditional multi-reader multi-case clinical study for a diagnostic AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a software system intended for managing and processing existing image data, not generating new diagnostic conclusions, the "acceptance criteria" are related to its functional performance, safety, and equivalence to its predicate.
| Acceptance Criteria Category/Area | Specific Criteria (Implied/Demonstrated) | Reported Device Performance (Demonstrated by Verification & Validation) |
|---|---|---|
| Indications for Use | Equivalence to predicate's IFU; no new risks associated with the updated IFU. | The IFU is "equivalent" to the predicate, with a minor textual change ("removal of the word 'storage' and display... due to an updated definition of MIMS") not constituting a substantial change. |
| Functionality (Medical Device Features) | Performance of core functions for patient data management, processing, and review as intended. | All new and/or modified medical device functions (e.g., fundus image processing, image annotations, bidirectional data exchange) were demonstrated through risk analysis and testing to not impact the safety, equivalence, risk profile, and technical specifications as compared to the predicate device. |
| Safety and Risk Profile | Risks associated with new/modified functions are mitigated and do not introduce new substantial concerns. | Appropriate risk analysis and testing documentation were provided to demonstrate that modifications do not impact substantial equivalence. The device was considered a "Moderate" level of concern, and verification/validation confirmed no indirect minor injury to patient or operator. |
| Technical Specifications | Updated platform/OS and other backend improvements maintain or enhance performance without adverse impact. | Backend improvements (e.g., updated Windows Server/Client versions, addition of Apple OS X BigSur support) were deemed equivalent as they do not impact indications for use, device risk profile, or technical specifications, as demonstrated by risk documentation and testing. |
| Non-Medical Device Functions | New non-medical accessories and functions (e.g., cloud connection, documentation storage) do not impact the core medical device functionality or safety. | The addition of non-medical accessories (e.g., for cloud connectivity) and non-medical functions does not impact the functionality or safety of the medical device, as demonstrated by appropriate risk assessments and testing information. |
| Software Verification & Validation | All requirements for proposed changes must be met, and testing must be performed according to FDA guidance. | "FORUM (version 4.3) has successfully undergone extensive software verification and validation testing to ensure that all requirements for proposed changes have been met." Documentation provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." All testing followed internally approved procedures. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of cases or patients. The "test set" here refers to the software verification and validation activities. These typically involve diverse test cases covering various functionalities, edge cases, and potential failure points, rather than a "patient test set" in a clinical study.
- Data Provenance: Not specified. For software verification and validation, the "data" would be test data (simulated or real but de-identified) used to exercise the software's functions.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable or specified. For this type of software, "ground truth" relates to the expected behavior of the software according to its design specifications. It doesn't involve medical experts adjudicating diagnoses in a test set.
- Qualifications of Experts: N/A for establishing "ground truth" in this context. Experts would be software engineers, quality assurance personnel, and potentially clinical subject matter experts for reviewing the functional requirements and outputs.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" for software verification is the expected output according to the design specification and requirements. Verification and validation are performed against these predetermined requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This type of study is typically performed for AI-powered diagnostic devices where human readers' performance with and without AI assistance is compared. FORUM is a management and processing system, not an AI diagnostic algorithm that provides assistance to human readers in the diagnostic task itself.
- Effect Size of Human Readers' Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? No, not in the sense of a standalone diagnostic algorithm's performance. The "standalone" performance for this device would refer to its ability to perform its specified functions (managing, processing, displaying data) correctly and reliably, which was assessed through software verification and validation. It's not a diagnostic algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Software functional specifications and requirements documents. The "truth" is whether the software behaves as designed and meets its technical and safety requirements.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. FORUM is a medical image management and processing system, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Established: Not applicable, as there is no training set for this type of device.
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Carl Zeiss Meditec AG % Maria Golovina Head of Regulatory - USA Carl Zeiss Meditec USA Inc 5300 Central Parkway Dublin, California 94548
Re: K213527
Trade/Device Name: Forum Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: NFJ Dated: June 30, 2022 Received: July 6, 2022
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213527
Device Name FORUM
Indications for Use (Describe)
FORUM is a software system intended for use in management, processing of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications (including but not limited to Retina Workplace).
FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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FORUM: 510(k) Summary
In accordance with 21 CFR 807.92, the following summary of information is provided in the 510(k) submission.
1. Identification of the Submitter
| Applicant | Carl Zeiss Meditec AGGoeschwitzer Strasse 51-52D-07745 Jena, Germany |
|---|---|
| Primary Contact | Maria GolovinaHead of Regulatory Affairs - USACarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(925) 216-1078 Phone (925) 557-4259 FaxE-mail: maria.golovina@zeiss.com (preferred) |
| Secondary Contact | Tanesha BlandSenior Regulatory Affairs Specialist- USACarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(925) 216-7963 PhoneE-mail: tanesha.bland@zeiss.com (preferred) |
| Date Prepared | August 11, 2022 |
2. Identification of the Product
| Trade Name | FORUM |
|---|---|
| Software Version | Software Version 4.3 |
| Classification/Common Name | System, Image Management, Ophthalmic |
| Device Class | II |
| Product Code | NFJ |
3. Predicate Device to which Equivalence is Claimed
Primary Predicate:
| Device Name | FORUM Archive and Viewer |
|---|---|
| Manufacturer | Carl Zeiss Meditec AG |
| Goeschwitzer Strasse 51-52 D-07745 Jena, Germany | |
| 510(k) Number | K122938 |
| Product Code | NFJ |
| Classification | System, Image Management, Ophthalmic |
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4. Summary of Device Description
FORUM and its accessories are a computer software system designed for management, processing, and display of patient diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications.
FORUM receives data via DICOM protocol from a variety of ophthalmic diagnostic instruments (such as CIRRUS, CLARUS, and 3rd Party systems), allows central data storage and remote access to patient data. This version of FORUM allows the user to access their data in the cloud via ZEISS developed non-medical device accessories. FORUM is an ophthalmic data management solution. FORUM provides basic viewing functionalities and is able to connect all DICOM compliant instruments.
This version of FORUM provides additional device functions such as review and annotation functionality of fundus images/movies, display of OCT image stacks, bidirectional data exchange between FORUM Workplaces, customization of document viewing abilities, user interface improvements, and user management updates.
This version of FORUM has additional non-medical device functions that are performed by non-medical device accessories, such as documentation storage, export of data in various formats, export to the cloud, improved IT integration capability into the existing IT network, image sorting, EMR log in improvements, numerous backend improvements with the purpose of streamlining clinical workflow.
5. Intended Use and Indications for Use
The Indications for Use (IFU) statement for the subject device is as follows:
FORUM is a software system intended for use in management, processing of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications (including but not limited to Retina Workplace, Glaucoma Workplace).
FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.
Prescription Use (Rx)
6. Substantial Equivalence Comparison to the Predicate Device
The substantial equivalence was drawn solely on the medical device features as they were related to the predicate.
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| Table 1. Subject Device to Reference Device Comparison (Technical Characteristics) |
|---|
| ------------------------------------------------------------------------------------ |
| Attribute/Function | Subject Device(K213527) | Primary Predicate Device(K122938) | EquivalencyAnalysis |
|---|---|---|---|
| Trade Name | FORUM | FORUM Archive andViewer | Updated |
| Software version | Software version 4.3 | Software version 3.0 | Updated |
| Manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Identical |
| Device ClassificationName | System, ImageManagement, Ophthalmic | System, ImageManagement, Ophthalmic | Identical |
| Regulation Description | Medical imagemanagement andprocessing system | Picture archiving andcommunications system | Equivalent.Regulation change. |
| Regulation medicalspecialty | Ophthalmic | Ophthalmic | Identical |
| Review panel | Ophthalmic | Ophthalmic | Identical |
| Product code,subsequent productcodes | NFJ – Class II | NFJ — Class II | Identical |
| Regulation number | 21CFR892.2050 | 21CFR892.2050 | Identical |
| Device class | II | II | Identical |
| Indications for use | FORUM is a softwaresystem intended for use inmanagement, processingof patient, diagnostic,video and image data andmeasurement fromcomputerized diagnosticinstruments ordocumentation systemsthrough networks. It isintended to work withother FORUMapplications (including butnot limited to RetinaWorkplace, GlaucomaWorkplace). | FORUM is a softwaresystem intended for use inmanagement, processing ofpatient, diagnostic, videoand image data andmeasurement fromcomputerized diagnosticinstruments ordocumentation systemsthrough networks. It isintended to work with otherFORUM applications. | Equivalent. Aremoval of the word'storage' and displayfrom the indicationsfor use due to anupdated definition ofMIMS does notconstitute asubstantial change,thus is deemedequivalent. |
| Attribute/Function | Subject Device(K213527) | Primary Predicate Device(K122938) | EquivalencyAnalysis |
| FORUM is intended foruse in review of patient,diagnostic and image dataand measurement bytrained healthcareprofessionals. | FORUM is intended for usein review of patient,diagnostic and image dataand measurement by trainedhealthcare professionals. | ||
| Application | Ophthalmology | Ophthalmology | Identical |
| Platform/OperatingSystem | Server:• Windows Server 2012 R2,• Windows Server 2016,• Windows Server 2019,• Windows 8.1,• Windows 10 | Server:• Windows XP (32 bit) with Service Pack 3• Windows Server 2003 (32 bit) with Service Pack 2• Windows 7 (64 bit) with Service Pack 1Windows Server 2008 R2 (64 bit) with Service Pack 1 | Equivalent; backendimprovements do notimpact theindications for use,device risk profile,and technicalspecifications of thesubject device asdemonstrated in riskdocumentation andtesting results. |
| Client:• Windows Server 2012 R2,• Windows Server 2016,• Windows Server 2019,• Windows 8.1,• Windows 10• Apple OS X 11.x (BigSur) | Client:• Windows XP (32 bit) with Service Pack 3• Windows 7 (64 bit) with Service Pack 1Windows Server 2008 R2 (64 bit, English Edition)• Apple OS 10.7 “Lion” | Equivalent; backendimprovements do notimpact theindications for use,device risk profile,and technicalspecifications of thesubject device asdemonstrated in riskdocumentation andtesting results. | |
| Database Features* | Central database: Yes | Central database: Yes | Identical |
| Administer patient data:Yes | Administer patient data: Yes | Identical | |
| Patient chart/ patientmanagement: Yes | Patient chart/ patientmanagement: Yes | Identical | |
| Search & sortpatients/documents: Yes | Search & sortpatients/documents: Yes | Identical | |
| Attribute/Function | Subject Device(K213527) | Primary Predicate Device(K122938) | EquivalencyAnalysis |
| Administer exam data:Yes | Store & administer examdata: Yes | Identical | |
| Search Exams: Yes | Search Exams: Yes | Identical | |
| Scheduling exams:Yes - Modality WorklistScheduler (Patient toDevice) | Scheduling exams:Yes - Modality WorklistScheduler (Patient toDevice) | Identical | |
| Image Processing | Image ProcessingFunction (Review ofmedical documents) -Fundus:Yes - Stereo view forfundus images, red greenblue (RGB) split forfundus images, display offundus angiographymovies, rotation of fundusimages, measurements onwide-field fundus images | Image Processing Function(Review of medicaldocuments) - Fundus:- Yes, to generalfunctionality- No, to specificfunctions ascompared to thesubject device | Different; however,the addition of thisfunctionality doesnot impact theindications for use,device risk profile,and technicalspecifications of thesubject device asdemonstrated in riskdocumentation andtesting results. |
| Image ProcessingFunction (Review ofmedical documents)Image Annotations:Yes, Addition of free handand circle measurementability, text annotations onimages, rotation | Image Processing Function(Review of medicaldocuments) ImageAnnotations:- Yes, to generalfunctionality- No, to specificfunctions ascompared to thesubject device | Different; however,the addition of thisfunctionality doesnot impact theindications for use,device risk profile,and technicalspecifications of thesubject device asdemonstrated in riskdocumentation andtesting results. | |
| Access/Connectivity* | Connection to LAN: Yes | Connection to LAN: Yes | Identical |
| DICOM Interface: Yes | DICOM Interface: Yes | Identical | |
| Remote data access viaInternet: No, only viaVirtual Private Network | Remote data access viaInternet: No, only viaVirtual Private Network | Identical | |
| Import exam data fromvarious ophthalmicdiagnostic devices: Yes | Import exam data fromvarious ophthalmicdiagnostic devices: Yes | Identical | |
| Attribute/Function | Subject Device(K213527) | Primary Predicate Device(K122938) | EquivalencyAnalysis |
| Interface to ElectronicMedical Records (EMRs)or Practice ManagementSystems: Yes | Interface to ElectronicMedical Records (EMRs) orPractice ManagementSystems: Yes | Identical | |
| Cloud Connection: Yesvia ZEISS developednon-medical deviceaccessories | Cloud Connection: No | Equivalent. Theaddition of the non-medical accessoriesthat support cloudconnectivity does notimpact theindications for useand do not impactthe functionality ofthe medical device. | |
| Data Exchange: Yes,bidirectional dataexchange betweenFORUM Workplaces | Data Exchange: Yes,unidirectional data exchangebetween FORUMWorkplaces | Different; however,the addition of thisfunctionality doesnot impact theindications for use,device risk profile,and technicalspecifications of thesubject device asdemonstrated in riskdocumentation andtesting results. | |
| Image/Data Transfervia DICOM | Yes | Yes | Identical |
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*The addition of new and/or modified medical device functions does not impact safety and equivalence of the subject device because risks associated with these functions were mitigated. Appropriate risk analysis and testing documentation was provided to demonstrate that these modifications do not impact the substantial equivalence as compared to the predicate device.
** The addition of new and/or modical functions and accessories does not impact safety and equivalence of the subject device because the functionality they provide does not have an impact to the FORUM medical device. This was demonstrated by providing appropriate risk assessments and testing information.
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7. Summary of the Studies
FORUM (version 4.3) has successfully undergone extensive software verification and validation testing to ensure that all requirements for proposed changes have been met. Software Verification and Validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
All testing followed internally approved procedures and processes. These procedures and processes are in compliance with referenced standards and FDA guidance documents.
8. Conclusion
The indications for use are equivalent to the indications for use of the predicate device; are deemed to be equivalent in their relationship to safety and effectiveness.
The technological characteristics and risk profile of the subject device are equivalent to the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
Testing methods are equivalent to those of the predicate device and reference device; and therefore, are deemed to be equivalent in their relationship to safety and effectiveness.
Therefore, the subject device meets the requirements for substantial equivalence.
§ 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).