The EXCELSIOR software is a cloud-based software that provides a grading platform integrating remote data collection, quantitative analysis and measurement, storage and management of ophthalmic data and images for clinical trials.

EXCELSIOR provides secure access through user authentication and role authorization, and is adherent to HIPAA and CFR 21 part 11 requirements for clinical investigations. EXCELSIOR user accounts can only be initiated by EXCELSIOR administrators or project managers: administrators or project managers enter in user information, and the user is prompted by email to setup his own user name and password. Once setup, the user access is defined by its role associated with a particular trial. EXCELSIOR provides 128-bit secure network encryption and audit trail logging to ensure that changes to the data are retraceable and re-constructible.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EyeKor EXCELSIOR Software, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the EXCELSIOR Software as an "image management system," primarily focusing on its functional equivalence to predicate devices (Topcon Medical Systems Synergy and Carl Zeiss Meditec Forum) rather than a diagnostic device with specific performance metrics like sensitivity or specificity.

Therefore, the "acceptance criteria" discussed are related to its intended use and technological characteristics rather than direct performance in a diagnostic task. The document asserts that the device meets these criteria by being substantially equivalent to the predicates.

Acceptance Criteria Category	Specific Criteria (Implicitly Met by Substantial Equivalence)	Reported Device Performance (as stated in the document)
Intended Use	Importing ophthalmic clinical images	Intended for importing ophthalmic clinical images.
	Processing ophthalmic clinical images	Intended for processing ophthalmic clinical images.
	Measurement of ophthalmic clinical images	Performs distance measurements, area measurements, ETDRS grid measurements, OCT layer thickness measurements, and macular grid summary.
	Analysis of ophthalmic clinical images	Intended for analysis of ophthalmic clinical images.
	Storage of ophthalmic clinical images	Intended for storage of ophthalmic clinical images.
	Management of clinical data (ophthalmic)	Intended for management of clinical data (ophthalmic).
	Use through a computerized network	Operates through a computerized network.
	Use in analysis of images/data obtained in clinical trials	Specifically intended for use in clinical trials.
Technological Characteristics	Client-server based application	Client-server based application.
	Web-based viewing of ophthalmic images	Web-based viewing of ophthalmic images.
	Central database for image storage	Images stored in a central database.
	Accessed from a PC using Windows server OS	Accessed from a PC using a Windows server operating system.
	Built in a SQL database	Built in a SQL database.
	Supports DICOM files (fundus photos, OCT)	Supports DICOM files for fundus photographs and OCT images.
	Supports PDF files for ophthalmic reports	Supports use of PDF files for reviewing ophthalmic reports.
	Ability to search for records	Allows the user to search for records (using subject IDs).
Regulatory/Certification	Compliance with DICOM standard	Tested and found in compliance with DICOM.
	Software validation and verification	Performed software validation and verification tests.
	HIPAA Adherence	Adherent to HIPAA requirements.
	CFR 21 Part 11 Adherence	Adherent to CFR 21 part 11 requirements.
	Secure access (user authentication, role authorization)	Provides secure access through user authentication and role authorization.
	128-bit secure network encryption	Provides 128-bit secure network encryption.
	Audit trail logging	Provides audit trail logging.

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

The provided text does not contain any information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "Performance Data" section primarily mentions compliance with DICOM and general software validation/verification, but not a clinical performance test set.

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

This information is not provided in the document as there's no mention of a clinical test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size for human readers with and without AI assistance. This device is an image management system, not a diagnostic AI.

6. Standalone Performance Study (Algorithm Only)

The document does not describe a standalone performance study in the context of a diagnostic algorithm's performance. The "performance data" refers to compliance with standards and general software functionality testing.

7. Type of Ground Truth Used

Since a clinical performance evaluation with a test set is not described, the concept of "ground truth" in terms of pathology, expert consensus, or outcomes data is not applicable in the provided text. The "ground truth" for the software validation would be adherence to functional specifications and standards like DICOM.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size, as it describes an image management system rather than a machine learning-based diagnostic algorithm that would typically require a training set.

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

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

Summary

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(130-

510(k) SUMMARY

APR 0 2 2013

EyeKor EXCLESSIOR Software

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

EyeKor, LLC. 505 S. Rosa Rd. Suite 10B Madison, WI 53719 Phone: (608) 206-3614 Contact Person: Yijun Huang, PhD

Additional Correspondent:

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: (978) 207-1245 Facsimile: (978) 824-2541

Date Prepared: February 19, 2013

Name of Device and Name/Address of Sponsor

EyeKor EXCELSIOR Software EyeKor, LLC. 505 S. Rosa Rd. Suite 10B Madison, WI 53719

Common or Usual Name

System, Image Management, Ophthalmic

Classification Name

Camera, Ophthalmic, AC-Powered 21 C.F.R. 892.2050 Product Code: NFJ

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`ır · Predicate Devices

Topcon Medical Systems Synergy (K093313) Carl Zeiss Meditec Forum (K090439)

Intended Use

Device Description

Performance Data

The EXCELSIOR Software has been tested and found in compliance with the following recognized consensus standard:

DICOM (Digital Imaging and Communications in Medicine) - Developed by the American College of Radiology and the National Electrical Manufacturers Association. Specifies the format for the communication of digital images between individual devices and over networks.

Additionally, software validation and verification tests were performed which confirmed that the software performed as intended.

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Technological Characteristics and Substantial Equivalence

The EXCELSIOR Software is intended for use in importing, processing, measurement, analysis and storage of ophthalmic clinical images as well as in management of clinical data, through a computerized network for use in analysis of images and data obtained in clinical trials. Both the identified predicate devices are ophthalmic image management systems intended for use in review and processing of ophthalmic images. Both EXCELSIOR and Synergy (K093313) are intended for use in importing, processing, measurement, analysis and storage of ophthalmic clinical images as well as management of data. Both systems receive the data through a computerized network. The differences between the intended uses primarily relate to the type of data being processed. In the case of EXCELSIOR, images and data related to subjects participating in a clinical trial is processed while Synergy processes data from patients in clinical practices. EyeKor believes that the similarity of the functions performed by the software products is sufficient to allow the intended uses to be determined to be similar.

The EXCELSIOR Software has very similar technological characteristics to the Forum and Synergy software programs. All of the software programs are client-server based applications with web-based viewing of ophthalmic images. All images are stored in a central database. All of the software programs are accessed from a PC using a Windows server operating system.

All of the software programs are built in a SQL database and support DICOM files for fundus photographs and OCT images. All of the systems support use of PDF files for reviewing ophthalmic reports. All of the systems allow the user to search for records related to a particular patient. One of the differences between the EXCELSIOR Software and the predicate devices is that images and reports accessed in the EXCELSIOR Software are accessed using subject identification numbers while Synergy and Forum access records based on the patient's name or other identifiable information. Since EXCELSIOR is used in a clinical trial environment this type of access is required.

In regards to measurements that may be made with the software programs, EXCELSIOR performs distance measurements, area measurements, ETDRS grid measurements, OCT layer thickness measurements, and macular grid summary. These are the same measurements performed by Synergy.

Therefore, the technological characteristics of the EXCELSIOR Software program are similar to the identified predicate devices.

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In summary, the company's EXCELSIOR Software has a similar intended use as the previously cleared predicate devices. In addition, the EXCELSIOR Software has similar technological characteristics and principles of operation as its predicates. Although there are differences between EXCELSIOR and its predicate devices, those differences do not raise new questions of safety or effectiveness. Thus, the EXCELSIOR Software is substantially equivalent.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

April 2, 2013

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

EveKor. LLC. % Ms. Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864

Re: K130453

Trade/Device Name: EXCELSIOR Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: NFJ Dated: February 20, 2013 Received: February 22, 2013

Dear Ms. O'Connell:

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, subiect to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting 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

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Page 2 - Ms. Maureen O'Connell

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Kesia YAlexander -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 Statement

K130453 510(k) Number (if known):_

Device Name: EXCELSIOR Software

Indications for Use:

Prescription Use _ X (Per 21 C.F.R. 801.109) Subpart C)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Andrew Yang -S 2013.03.12 11:48:48 -04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K130453

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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).