The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, clinical images and information, reports and measurements of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.

Device Description

The RetinAl Discovery consists of a platform which displays and analyzes images of the eye (e.g. OCT scans and fundus images) along with associated measurements (e.g. layer thickness) generated by the user through Discovery. The platform allows the user to manually segment layers and volumes in the images, it calculates the layer thickness and volume from annotated images and presents the progression of the measurement in graphs. Discovery provides a tool for measuring ocular anatomy and ocular lesion distances. The multiple views in Discovery and the measurements allow the user to assess the eye anatomy and, ultimately, assist the user in making decisions on diagnosis and monitoring of disease progression.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for RetinAI Discovery, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific metrics (e.g., accuracy percentages, Dice scores). Instead, the performance is described through comparison testing demonstrating equivalence with predicate/reference devices for manual segmentation and image measurement of retinal OCT scans.

Acceptance Criteria (Inferred)	Reported Device Performance
Equivalence in manual segmentation of retinal layers	Comparison testing showed "the computed values from the Discovery platform are substantially equivalent to the computed values from the Reference Devices (Heidelberg Engineering Spectralis HRA+OCT and Topcon DRI OCT Triton), for both Optimized and Device display modes." This implies the results of manual segmentation in Discovery do not significantly differ from those obtained from the established reference devices.
Equivalence in image measurement of retinal OCT scans	Comparison testing showed "the computed values from the Discovery platform are substantially equivalent to the computed values from the Reference Devices (Heidelberg Engineering Spectralis HRA+OCT and Topcon DRI OCT Triton), for both Optimized and Device display modes." This indicates that measurements performed within Discovery are consistent with measurements from the reference devices.
Functioned as intended	"In all instances, Discovery functioned as intended and expected performance was reached." This suggests the software operated without critical errors or deviations from its design specifications during testing.
IEC 62304 and IEC 82304 compliance (Software Development)	The device was "designed, developed and tested according to the software development lifecycle process implemented at RetinAI Medical AG, based on the IEC 62304 and IEC 82304 standards, and the FDA Guidance for the 'General Principles of Software Validation'." This indicates adherence to accepted software development and validation practices for medical devices, which are a form of acceptance criteria for the development process. Testing included "verification and validation activities (static code analysis, unit and integration testing, system and functional testing)."
No new questions of safety or effectiveness from technological differences	"The minor technological differences between the RetinAI Discovery and its predicate device do not raise different questions of safety or effectiveness." This is a key regulatory acceptance criterion for substantial equivalence.

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

The document does not explicitly state the numerical sample size for the test set (number of OCT scans or patients).

Test Set: Implied to be the same images used for comparison testing with the reference devices.
Data Provenance: Not specified. The document states "comparison testing was performed... with the same images segmented in cleared devices," but does not explicitly mention country of origin or whether the data was retrospective or prospective.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth. The comparison testing relies on the "computed values from the Reference Devices" as the standard, implying that the ground truth is derived from the established and cleared functionalities of those devices when experts perform manual segmentation or measurements within them.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method for a test set in the traditional sense of multiple human readers independently assessing and then reaching a consensus. Instead, the "ground truth" for the comparison study appears to be the output of the cleared reference devices when manual segmentation/measurements are performed by users (presumably clinicians or operators) within those systems.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a standalone performance validation comparing RetinAI Discovery's manual segmentation and measurement capabilities with those of existing cleared devices. There is no mention of human readers improving with or without AI assistance, as the device's main specified function (based on the provided text) is for displaying, analyzing, and manual labeling/annotation, not AI-powered automated analysis or decision support for human readers.

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

Yes, a standalone performance validation was done for the manual segmentation and image measurement functionalities of the RetinAI Discovery. The device itself is described as a "standalone, browser-based software application." The comparison testing verified the performance of the Discovery platform's manual segmentation and measurement tools against the established reference devices, essentially testing the accuracy of the tools themselves "without human-in-the-loop performance" improvement claims. The document focuses on the platform's ability to facilitate manual activities.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the comparison testing was effectively the "computed values from the Reference Devices" (Heidelberg Engineering Spectralis HRA+OCT and Topcon DRI OCT Triton). This implies that the accepted and pre-cleared outputs of these established ophthalmic imaging and analysis devices, whether derived from their automatic or manual segmentation/measurement tools, served as the benchmark for evaluating RetinAI Discovery.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size. This is consistent with the nature of the device as described, which is specified for manual labeling and annotation and general image management/display, not for an AI model that requires a large training dataset.

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

As no training set is mentioned for an AI model, the method for establishing ground truth for a training set is not applicable here. The described studies focus on the validation of the manual tools and general software functions.

Summary

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April 28, 2022

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RetinAI Medical AG Enisa Dresevic Head of Quality and Regulatory Affairs Freiburgstrasse, 3 Bern. 3010 Switzerland

Re: K211715

Trade/Device Name: RetinAI Discovery Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: NFJ Dated: March 25, 2022 Received: March 25, 2022

Dear Enisa Dresevic:

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 (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,

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)

K211715

Device Name

RetinAl Discovery

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

RetinAl Discovery

Submitter: RetinAl Medical AG Freiburgstrasse 3 3010 Bern Switzerland

Phone: +33 6 29 39 55 25 Contact Person: Enisa Dresevic

Date Prepared: April 27, 2022

510(k) number: K211715

Name of Device: RetinAl Discovery Classification Name: Medical image management and processing system Requlatory Class: II Product Code: NFJ

Predicate Device Optos PLC's OptosAdvance (K162039)

Reference Devices Topcon DRI OCT Triton (K173119) Heidelberg Engineering Spectralis (K173648)

Intended Use / Indications for Use

The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.

Device description

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Summary of Technological Characteristics

Both the subject and predicate device are standalone software devices intended to display and analyze previously-acquired images of the eye in order to streamline review of such images by healthcare professionals. Both devices are browser-based platforms that can be used on a variety of web browsers (i.e., Google Chrome, Mozilla Firefox, Microsoft Edge) and feature similar capabilities. The principal difference between the products relates to the availability in Discovery of a wider range of viewing layouts compared to the predicate device. A table comparing the key features of the subject and predicate devices is provided below.

The validation of RetinAl Discovery performance is supported by comparison testing with two Reference Devices, Heidelberg Engineering SPECTRALIS HRA+OCT (K173648) and Topcon DRI OCT Triton (K173119). While Discovery is a standalone, browser-based software application, the cleared devices selected as Reference Devices are imaging devices which include ophthalmic image management and data analysis software. The Heidelberg Engineering SPECTRALIS HRA+OCT (K173648) and Topcon DRI OCT Triton (K173119) offer automatic segmentation of retinal layers and measurement features, but also a manual segmentation tool, similar to the one included in the Discovery platform.

RetinAl Discovery	OptosAdvance(K162039)Primary PredicateDevice	Topcon DRI OCTTriton (K173119)Reference Device 1	HeidelbergEngineeringSpectralis (K173648)Reference Device 2
IntendedUse	RetinAl Discovery isa standalone,browser-basedsoftware applicationintended for use byhealthcareprofessionals toimport, store,manage, display,analyze andmeasure data fromophthalmicdiagnosticinstruments,including: patientdata, diagnosticdata, clinical imagesand information,reports, andmeasurement ofDICOM-compliantimages. The device	OptosAdvance 4.0 is astandalone,browser-based softwareapplication intended foruse by healthcareprofessionals to import,store, manage, display,analyze and measuredata from ophthalmicdiagnostic instruments,including: patient data,diagnostic data, clinicalimages and information,reports, videos, andmeasurement ofDICOM-compliantimages.	The Topcon DRI OCTTriton is a non-contact,high resolutiontomographic andbiomicroscopic imagingdevice thatincorporates a digitalcamera forphotographing,displaying and storingthe data of the retinaand surrounding partsof the eye to beexamined underMydriatic andnon-Mydriaticconditions.The DRI OCT Triton isindicated for in vivoviewing, axial crosssectional, and	The SPECTRALIS is anon-contact ophthalmicdiagnostic imagingdevice. It is intendedfor:• viewing the posteriorsegment of the eye,including two- andthree-dimensionalimaging• cross-sectionalimaging (SPECTRALISHRA+OCT andSPECTRALIS OCT)• fundus imaging• fluorescence imaging(fluoresceinangiography,indocyanine greenangiography;SPECTRALISHRA+OCT,

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				subjects• a reference databasefor retinal nerve fiberthickness and opticnerve headneuroretinal rimparametermeasurements,which is used toquantitatively comparethe retinal nerve fiberlayer and neuroretinalrim in the human retinato values ofnormal subjects ofdifferent races andethnicities representingthe population mix ofthe USA (GlaucomaModulePremium Edition)
ProductCode	NFJ	Same	OBO, HKI	OBO, MYC
UserPopulation	HealthcareProfessionals	Same	Same	Same
TechnologicalCharacteristics	Standalone software	Same	OCT device used incombination with Tritondata analysis software	OCT device used incombination withHeyex data analysissoftware
OperatingSystem	Browser-based	Same	Local installation of thesoftware	Local installation of thesoftware
Data andSupportedFormats	DICOM-compliantfiles from anophthalmic device,such asFundusphotographs, OpticalCoherenceTomography (OCT)scans	DICOM-compliant filesfrom an ophthalmicdevice (Scanning LaserOphthalmoscope,Fundus Camera, OpticalCoherence Tomographyunit, etc.)	Images acquired fromthe Topcon OCT device	Images acquired fromthe Spectralis OCTdevice andDICOM-compliant filesfrom an ophthalmicdevice

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SupportedMachines	DICOM-compliantdevices	Integration with eyecarediagnostic devices viaDICOM	Topcon	Spectralis andDICOM-compliantdevices
ImageAnnotation andMeasurement	Yes	Same	Data is automaticallyprocessed withanalysis functions suchas the automatic retinallayers segmentation,the automatic thicknesscalculation with severalgrids, the optic discanalysis andcomparison with areference database ofeyes free of ocularpathology, and is finallyautomatically saved tothe PC. It allows theuser to manually adjustthe automated retinallayer segmentationresults and optic discanalysis results.	Data is automaticallyprocessed,segmentation of retinallayers and relativemeasurements aredisplayed in theinterface throughreports. It allows theuser to manually adjustthe automated retinallayer segmentationresults
Sharing	Share images withcurrent layout withanother user viashareable link	Same	Sharing is not available	Drag-and-drop exportsharing

Standards compliance

Discovery complies with the following standards:

Standards	Standards organization	Standards title
PS 3.1 - 3.20(2021e)	NEMA	Digital Imaging and Communications inMedicine (DICOM) Set
62304 Edition 1.12015-06Consolidated version	AAMI / ANSI / IEC	Medical device software - Software life cycleprocesses
82304-1 Edition 1.02016-10	AAMI / ANSI / IEC	Health software - Part 1: Generalrequirements for product safety

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14971:2019	AAMI / ANSI / ISO	Medical Devices - Application of riskmanagement to medical devices
15223-1 ThirdEdition 2016-11-01	AAMI / ANSI / ISO	Medical devices - Symbols to be used withmedical devices labels, labeling andinformation to be supplied - Part 1: Generalrequirements

Regarding the compliance to the PS 3.1 - 3.20 (2021e) standard, RetinAl Discovery supports reading of DICOM objects obtained from Media Storage and File Format for Data Interchange PS 3.10 files loaded from the local file system or from PS 3.12 compliant media according to one of the General Purpose Media Application Profiles of PS 3.11.

Performance Data

Discovery was designed, developed and tested according to the software development lifecycle process implemented at RetinAl Medical AG, based on the IEC 62304 and IEC 82304 standards, and the FDA Guidance for the "General Principles of Software Validation". Testing included verification and validation activities (static code analysis, unit and integration testing, system and functional testing). In addition, comparison testing was performed to demonstrate the equivalence of the manual segmentation and image measurement of retinal OCT scans in Discovery platform, in both "Optimized" and "Device" display modes, with the same images segmented in cleared devices, Heidelberg Engineering Spectralis HRA+OCT (K173648) and Topcon DRI OCT Triton (K173119). The results showed that the computed values from the Discovery platform are substantially equivalent to the computed values from the Reference Devices, for both Optimized and Device display modes.

In all instances, Discovery functioned as intended and expected performance was reached.

Software Verification and Validation Testing

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 result in minor injury to the patient through incorrect or delayed information or through the action of a care provider.

Conclusions

The RetinAl Discovery performs in a manner that is substantially equivalent to the predicate device, OptosAdvance. The RetinAl Discovery has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the RetinAl Discovery and its predicate device do not raise different questions of safety or effectiveness. Thus, the RetinAl Discovery is substantially equivalent.

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).