OptosAdvance 4.0 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, videos, and measurement of DICOM-compliant images.

Device Description

The OA4 software application provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The OptosAdvance user interface follows typical clinical workflow patterns to process, review, and analyze digital images.

The key features of OptosAdvance 4.0 include the ability to:

Acquire, store, retrieve and display DICOM image data;
Access patient data securely:
Search patient studies and select images for closer examination:
Interactively manipulate an image to visualize anatomy and pathology;
Select multiple images for comparison;
Annotate, tag and record selected views;
Measure distance (linear) and area of DICOM images;
Manage, backup and archive data;
Import and export data to network storage devices;
Securely access and transfer data: and
Output selected views to printers.

The software relies on images being provided to a specified network path on the OptosAdvance Server by the connected ophthalmic device (Scanning Laser Ophthalmoscope, Fundus Camera, Optical Coherence Tomography unit, etc.) in a DICOM-compliant format. The software will then place the image and associated data on the network storage unit in a format which will allow the image to be available via a securely connected web browser. Locally archived studies will be securely pushed to the remote archive server for storage. The archive in the remote secure server serves as disaster recovery storage as well as access to the patient history.

AI/ML Overview

The provided text describes OptosAdvance 4.0 software, a Picture Archiving and Communication System (PACS), and its substantial equivalence to predicate devices. The approval is based on non-clinical performance testing.

Here's a breakdown of the requested information:

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

Acceptance Criteria	Reported Device Performance
Operates according to requirements	Software testing ensured that new features operate according to requirements and without impact to existing functionality.
Maintains existing functionality	Software testing confirmed no impact to existing functionality.
Provides equivalent measurements (linear & area)	Equivalence tests were performed by loading DICOM objects with known dimensions, users measuring these features, and comparing their measurements with the known dimensions. The text implies successful equivalence, stating "OptosAdvance 4.0 software application provides equivalent measurements."
Risk Management	Each risk pertaining to OptosAdvance 4.0 was individually assessed, reduced to "as low as possible," and evaluated to have a probability of occurrence of harm of no more than "Remote." All risks were collectively reviewed, and benefits were determined to outweigh the risks.
Cybersecurity risks addressed	The device was designed and tested considering potential cybersecurity risks to ensure confidentiality, integrity, availability, and accountability.
Images display at same resolution and clarity	Verification and validation testing for the subject software covered the comparison of images on custom software and the web client, which were found to display at the same resolution and clarity. (This implicitly refers to comparison with the predicate device's display capabilities or internal consistency).
Functionality equivalent to predicates	The device's acquisition, importing, viewing, measurement and analysis, network and security, print, archive, and backup functionalities are similar to the predicate devices. Minor technological differences were determined not to raise new issues of safety or effectiveness. (This is a more qualitative criterion based on overall functionality, supported by detailed comparisons.)

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

The document does not explicitly state the sample size for the test set or the data provenance for the performance testing. It mentions "previously acquired medical images" for verification, validation, and evaluation, and "DICOM objects that contain features with known dimensions" for equivalence tests. This suggests the use of retrospective or simulated data, but specifics are not provided. Given the nature of a PACS system, the "data" would consist of DICOM images.

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)

The document does not specify the number of experts or their qualifications used to establish ground truth. For the measurement equivalence tests, "known dimensions" implies a pre-established ground truth, likely from the creation of the DICOM objects themselves or from other validated measurement tools, rather than expert annotation.

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

The document does not describe any adjudication method. The performance testing appears to be based on objective comparisons (e.g., measured values vs. known dimensions, checking if features operate as required) rather than subjective expert review requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. OptosAdvance 4.0 is a PACS system designed for managing, displaying, and measuring ophthalmic data, not for providing AI assistance to human readers for diagnostic interpretation. Therefore, there is no mention of human reader improvement with or without AI assistance. The submission specifically states: "Thus, clinical studies are not required to support the subject device's safety and effectiveness; the non-clinical objective test methods used for evaluation demonstrate that the software's performance is equivalent to that of the legally marketed predicates."

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

Yes, the performance testing described is effectively standalone testing of the software's functionalities. The "equivalence tests" for measurements involve the software's ability to provide measurements accurately compared to known dimensions. The overall software verification and validation are for the algorithm's performance in managing and displaying data, not for human-in-the-loop diagnostic accuracy. The device itself is described as a "standalone, browser-based software application."

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

For the measurement tests, the ground truth was "known dimensions" embedded within DICOM objects. For general software functionality, the ground truth would be the defined requirements and specifications of the software.

8. The sample size for the training set

The document does not describe a training set. This is not an AI/machine learning device that requires a training set. It is a PACS system.

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

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three heads in profile, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

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

February 8, 2017

Optos Plc % Mr. Randy Prebula Partner Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004

Re: K162039

Trade/Device Name: OptosAdvance 4.0 (OA4) Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: December 29, 2016 Received: December 29, 2016

Dear Mr. Prebula:

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 (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

{1}------------------------------------------------

forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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,

Denise L. Hampton -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

{2}------------------------------------------------

510(k) Number (if known)

K162039

Device Name

OptosAdvance 4.0

Indications for Use (Describe)

OptosAdvance 4.0 is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, and measure data from ophthalmic diagnostic instruments, including: patient data, diagnostic data, clinical images and information, reports, videos, and measurement of DICOMcompliant images.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

Optos Plc's OptosAdvance 4.0 Software

In accordance with 21 CFR §807.92 the following summary of information is provided:

SUBMITTER:	Optos PlcQueensferry HouseCarnegie CampusEnterprise Way, DunfermlineFife, KY11 8GR,United KingdomFDA Registration Number: 9671767
Phone:Facsimile:	011 44 1383 843300011 44 1383 843333
Primary Contact Person:	Paul BurnsVice President, Regulatory Affairs & Quality AssuranceOptos PlcPhone: +44 1383 843470Email: pburns@optos.com
Secondary Contact Person:	Randy PrebulaU.S AgentHogan Lovells U.S. LLP555 13th Street NWWashington, DC 20004U.S.A.Phone: +1 202-637-6548Facsimile: +1 202-637-5910Email: randy.prebula@hoganlovells.com
Date Prepared:	July 22, 2016
DEVICE:
Trade Name:	OptosAdvance 4.0 (OA4) Software
Common or Usual Name:	Picture Archiving and Communication System (PACS)
Classification Name:	System, Image Management, Ophthalmic(per 21 C.F.R. § 892.2050)
Device Classification:	Class II
Product Code:	NFJ

{4}------------------------------------------------

LEGALLY MARKETED PREDICATE DEVICES

Predicate Device Name: OptosAdvance Software 510(k) Number: K113696 Manufacturer: Optos Plc

Predicate Device Name: Synergy ODM 510(k) Number: K151952 Topcon Medical Systems, Inc Manufacturer:

INTENDED USE / INDICATIONS FOR USE

DEVICE DESCRIPTION

The key features of OptosAdvance 4.0 include the ability to:

· Acquire, store, retrieve and display DICOM image data;
· Access patient data securely:
· Search patient studies and select images for closer examination:
Interactively manipulate an image to visualize anatomy and pathology;
· Select multiple images for comparison;
· Annotate, tag and record selected views;
· Measure distance (linear) and area of DICOM images;
Manage, backup and archive data;
· Import and export data to network storage devices;
· Securely access and transfer data: and
Output selected views to printers.

PERFORMANCE TESTING

OptosAdvance 4.0 is designed and tested according to the software development lifecycle process implemented at Optos Plc. Software testing was completed to ensure the new feature operates according to requirements and without impact to existing functionality. Testing included verification, validation, and evaluation of previously acquired medical images.

{5}------------------------------------------------

For additional reassurance, equivalence tests were performed to verify that the OptosAdvance 4.0 software application provides equivalent measurements by loading DICOM objects that contain features with known dimensions, displaying these objects to the user, having the user measure these features, and comparing their measurement with the known dimensions.

Risk Management

Each risk pertaining to OptosAdvance 4.0 has been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of no more than "Remote". All risks for the updated software feature were collectively reviewed to determine if the benefits outweigh the risk.

The proposed device has been designed and tested taking into account potential cybersecurity risks, to ensure confidentiality, integrity, availability and accountability.

Standards Compliance

Standard No.	Standards organization	Standards Title
PS 3.1 - 3.20 (2014c)	NEMA	Digital Imaging and Communications in Medicine (DICOM) Set
14971:2012	AAMI / ANSI / ISO	Medical Devices – Applications of risk management to medical devices
62304:2006	AAMI / ANSI / IEC	Medical Device Software - Software life cycle processes
62366-1 Edition 1.0 2015-02	IEC	Medical Devices – Part 1: Application of usability engineering to medical devices

The OptosAdvance 4.0 software complies with the following voluntary standards:

Clinical Data

OptosAdvance 4.0 is a PACS system that processes DICOM data. Therefore, any clinical comparison with a predicate that operates per the same DICOM standard will produce the same Thus, clinical studies are not required to support the subject device's safety and result. effectiveness; the non-clinical objective test methods used for evaluation demonstrate that the software's performance is equivalent to that of the legally marketed predicates. Nevertheless, the anticipated clinical equivalence was confirmed with a clinical case.

SUBSTANTIAL EQUIVALENCE

The proposed device is of the same type, common name, classification, and product code as the cleared predicate devices. The devices have the same intended use, and the indications for use of OptosAdvance 4.0 are very similar to the indications for use of the predicate software devices.

OptosAdvance 4.0 is also functionally equivalent to these devices. The proposed and predicate devices are all software-only image management systems with similar acquisition, importing, viewing, measurement and analysis, network and security, print, archive and backup functionalities. The minor technological differences between OptosAdvance 4.0 and its predicate devices raise no new issues of safety or effectiveness, as described below.

{6}------------------------------------------------

The key difference between the predicate OptosAdvance software (K113696) and the new version of OptosAdvance is the introduction of features to measure distance (linear) and area of DICOM images. The predicate Synergy ODM device (K151952) provides such line and area measurement capabilities, so the inclusion of this feature in the subject software does not raise different questions of safety or effectiveness.

The devices also differ slightly in their approach to data management backup and archiving. While the cleared Synergy ODM uses locally installed customized software to allow the user to view images stored on the local or networked computer system, OptosAdvance 4.0 uses the computer system's web browser with no other software installation required to allow the user to view DICOMcompliant images stored on the server. The verification and validation testing for the subject software covered the comparison of images on custom software and the web client, which were found to display at the same resolution and clarity. OptosAdvance 4.0 also allows the user to connect to a remote secure server to allow greater archiving flexibility. The only minor difference to OptosAdvance 4.0 from Synergy ODM in this respect is that the user can set up an HTTPS connection to the remote server to transfer data to and from the archive, providing greater flexibility on storage. A similar mechanism exists in the Synergy ODM software, where data can be stored on an external network location and accessed externally. In order to do this remotely in the OptosAdvance 4.0 software, a secure protocol is introduced to protect data integrity.

CONCLUSION

OptosAdvance 4.0 has the same intended use and indications for use as the Optos predicate device (K113696), and has very similar principles of operation and technological characteristics as both predicate devices (K113696 and K151952). Any minor differences noted have been explained and do not raise any different questions of safety or effectiveness when the software is used as labelled. The implemented design controls, risk management activities, labelling, and performed tests (software verification & validation) demonstrate the safety and efficacy of the device in comparison to the predicates. Therefore, based on the comparison and test data, the OptosAdvance 4.0 software application is as safe and effective as, and substantially equivalent to, the predicate devices.

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).