The IRIS Intelligent Retinal Imaging Systems is a comprehensive web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data and images from computerized diagnostic instruments or systems. Original and color amplified images can be viewed by trained healthcare professionals.

Device Description

The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera, transmit the images up to a website and offer an opinion on the scans. It also allows users the ability to input data relative to a visual fields exam. The combination of a fundus picture and visual fields data allows a licensed/credentialed clinician to evaluate the patient for glaucoma.

AI/ML Overview

The provided document is a 510(k) summary for the IRIS Intelligent Retinal Imaging System. This summary states that no performance data was required or provided for the device to support substantial equivalence. The submission relies solely on software validation and verification to demonstrate that the software performs as intended.

Therefore, many of the specific questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be answered from the text. The document explicitly states, "No performance data was required or provided."

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

Cannot be answered from the text. No test set performance data was provided or required.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be answered from the text. No ground truth for a test set was established as no performance study was conducted.

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

Cannot be answered from the text. No test set performance data was provided or required.

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

Cannot be answered from the text. No MRMC study was mentioned or performed. The device is described as an "Ophthalmic Image Management System" and "web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data and images." It does not appear to involve AI assistance for diagnosis, but rather provides tools for clinicians to review images and input their opinions.

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

Cannot be answered from the text. No standalone performance study was mentioned or performed.

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

Cannot be answered from the text. No ground truth was established for "performance data" as none was required or provided. The system allows licensed/credentialed clinicians to input their "discreet opinions" and "care plan based on grading levels chosen," implying human expert opinion is the primary diagnostic mechanism.

8. The sample size for the training set

Cannot be answered from the text. The document describes the device as a software application for managing and displaying images and data, not an algorithm that requires a training set in the typical machine learning sense for diagnostic purposes.

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

Cannot be answered from the text. As above, the nature of the device does not suggest a training set for a diagnostic algorithm.

In summary: The IRIS Intelligent Retinal Imaging System was cleared based on substantial equivalence to predicate devices, focusing on its function as an image management and display system. The FDA did not require or receive performance data related to diagnostic accuracy from the device's algorithms (as it appears to be a viewing and management system, not an AI diagnostic tool itself), thus bypassing the need for a study with acceptance criteria, test sets, or ground truth establishment.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 27, 2015

IRIS Intelligent Retinal Imaging Systems, LLC Ora, Inc Mr. Ryan Bouchard Director Medical Devices 300 Brickstone Square Andover, MA 01810

Re: K141922

Trade/Device Name: IRIS Intelligent Retinal Imaging System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: January 16, 2015 Received: January 20, 2015

Dear Mr. Bouchard:

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. 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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -S

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) K141922

Device Name

IRIS Intelligent Retinal Imaging System

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

This summary of the 510(k) premarket notification for the IRIS Intelligent Retinal Imaging Systems is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.

Date Prepared: August 15, 2014

SPONSER/ 510(k) OWNER/ MANUFACTURER

Intelligent Retinal Imaging Systems, LLC P.O. Box 13272 Pensacola, FL 32591

CONTACT PERSON

Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 Telephone: (978) 332-9574 Facsimile: (978) 689-0020 E-mail: rbouchard@oraclinical.com

NAME OF DEVICE

Trade Name: IRIS Intelligent Retinal Imaging System Common Name: Ophthalmic Image Management System

DEVICE CLASSIFICATION/FDA REVIEWING BRANCH

The Ophthalmic Branch has classified Ophthalmic Image Management Systems as Class II devices pursuant to 21 C.F.R. §892.2050.

PRODUCT CODE: CLASSIFICATION / CFR TITLE

NFJ, 21 CFR 892.2050

PREDICATE DEVICES

Optos Advance Software (K113696) Zeiss Forum (K122938)

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INDICATIONS FOR USE

PRODUCT DESCRIPTION

A patient presents to a provider's office where a retinal scan is ordered by a licensed provider. The patient then sits with a technician at a fundus camera where one or more images are captured of the patient's retina using flash fundus photography. The images are then exported to the Internet based application. A licensed provider then logs into the application, reviews the images, inputs their discreet opinions on a number of suspected conditions such as Diabetic Retinopathy, Macular Edema, Glaucoma, Dry MD, Wet MD, Vein Occlusion, HTN Retinopathy, Macular Hole, Epiretinal Membrane, Cataract, and others. The provider then inputs a care plan based on grading levels chosen. The results are then sent back to the client for inclusion in the patient's chart and for possible follow up.

Secondarily, a patient presents to clinician's office and a glaucoma screening is ordered. The patient then sits with a technician at a visual fields system and a visual fields examination is performed. Following the examination, if the patient has not had a recent fundus evaluation, the previous workflow is followed where a patient has flash fundus images taken of one or both eyes. Following that examination, the visual fields data is entered into the application and is saved as a new evaluation. A licensed/credentialed physician then logs into the system, reviews the data and images, inputs their discreet opinions, and finally signs the result.

The application is fully HIPAA compliant encrypting all protected health information related to a patient's demographics using an encryption key stored separately from the database specific to each clinic utilizing the service. The application should require no modification to a client's security infrastructure to transmit the images up to the IRIS system or to download a result to the patient's chart.

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The application is developed on the Microsoft .NET platform stack. It utilizes the C# (c sharp) programming language to program the parts of the system that interact with backend services including the patient relational database system, client communication software, and the web front end. IRIS accepts files in DICOM and JPEG format.

SUBSTANTIAL EQUIVALENCE

The IRIS Intelligent Retinal Imaging Systems software is substantially equivalent to a combination of the Optos Advance Software (K113696) and the Zeiss Forum (K122938). The IRIS Intelligent Retinal Imaging Systems software has a similar intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicates. Therefore, the IRIS Intelligent Retinal Imaging Systems software is substantially equivalent to the predicate device.

The IRIS Intelligent Retinal Imaging Systems is a comprehensive web-based software system application intended for storing, managing, and displaying patient data, diagnostic data and images from computerized diagnostic instruments or systems. Original and color amplified images can be viewed by trained healthcare professionals for use in analysis of images and data. This indications for use statement is similar to the indications for use statement for the Optos Advance Software cleared in K113696 with the exception that the Optos Advance Software also handles videos and video documentation while the IRIS system does not. The indications for use statement is also similar to the indications for use statement for the Zeiss Forum cleared in K122938 with the exception that the Forum system handles images and performs measurements while the IRIS system does not perform any measurements. The IRIS Intelligent Retinal Imaging Systems has the same intended use and similar indications for use as the predicate devices and may therefore be found substantially equivalent.

The IRIS Intelligent Retinal Imaging Systems has very similar technological characteristics to the Optos Advance Software and the Zeiss Forum software. All of the systems are software only; there are no hardware components. The IRIS software and the Optos Advance Software are both web-based viewing platforms while the Zeiss Forum has an option for a local client application. All of the software products have centralized storage of images and data. All of the products support files for uploading fundus photographs and all of the software products support non-mydriatic image capture devices. All of the products perform image data management. All of the products allow for management and review of fundus images while the IRIS software and Zeiss Forum also allow management and review of visual field images. All of the products allow importing of image files and enhancement or color amplification of images.

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Therefore, the technological characteristics of the IRIS Intelligent Retinal Imaging Systems software are similar to the identified predicate devices.

In summary, the IRIS Intelligent Retinal Imaging Systems software has a similar intended use as the previously cleared predicate devices. In addition, IRIS Intelligent Retinal Imaging Systems software has similar the technological characteristics and principles of operation as its predicates. Although there are differences between the IRIS Intelligent Retinal Imaging Systems and its predicate devices, those differences do not raise new questions of safety or effectiveness. Thus, the IRIS Intelligent Retinal Imaging Systems is substantially equivalent.

PERFORMANCE DATA

No performance data was required or provided. Software validation and verification was performed which showed that the software performed as intended supporting substantial equivalence to the predicate devices.

CONCLUSIONS

IRIS Intelligent Retinal Imaging Systems has the same intended use and indications for use, technological characteristics, and principles of operation as the previously cleared predicates. The minor differences between the subject device and the predicate devices so not raise new questions of safety or effectiveness. Therefore, the IRIS Intelligent Retinal Imaging Systems 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).