OIS Symphony is a comprehensive software platform for the import, integration and review of patient data and clinical information in an eye care environment. OIS Symphony allows for the collection, management, enhancement and review of the patient demographics, image data, diagnostic data and clinical reports from a variety of medical devices through either a direct connection with the instruments or through computerized networks.

Device Description

The OIS Symphony System is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. OIS Symphony consists of image display via Symphony Web, Image Import via Symphony Import and integration of imaging performed in OIS WinStation.

OIS Symphony is a software solution consistent with the predicate devices listed herein, using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment.

Symphony provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.

AI/ML Overview

This document describes the OIS Symphony Image Management System, a software solution for managing ophthalmic patient data and images. However, the provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a formal study.

Here's what can be extracted from the provided text, and what is missing:

Missing Information:
The primary request for acceptance criteria and a study proving their fulfillment cannot be answered from this document. The document states "Final testing of OIS Symphony included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications," but does not provide details on these tests, their specific acceptance criteria, or the results.

Information that can be extracted (or confirmed as absent):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not provided. The document mentions "functional specifications" but does not detail them or any associated quantitative or qualitative acceptance criteria.
- Reported Device Performance: Not provided against any specific criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned.
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):
- Not applicable as no specific performance study with ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no specific performance study with ground truth establishment is described.
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 study is mentioned. This device is an image management system, not an AI diagnostic tool, so such a study would likely not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The OIS Symphony is a software platform for data management and display, not an AI algorithm performing standalone diagnostic tasks.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific performance study with ground truth establishment is described.
The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that would typically have a "training set." It's a software system for data management.
How the ground truth for the training set was established:
- Not applicable.

Summary based on the provided text:

The OIS Symphony Image Management System is a software solution for displaying, managing, archiving, and integrating ophthalmic device reports, images, and data. It functions by using databases for patient demographics, servers, and intercommunication systems via HL7 and DICOM. The manufacturer claims that the device has undergone "extensive performance testing and validation" to ensure it met "all its functional specifications." However, the document does not elaborate on these specifications, the testing methodology, the sample sizes used, or the results of these tests.

The primary method for demonstrating safety and effectiveness in this 510(k) summary is by showing substantial equivalence to existing predicate devices (Zeiss Forum, Nidek NAVIS, and Topcon Synergy), highlighting that it employs similar technological characteristics and has a comparable intended use. The FDA's letter confirms the determination of substantial equivalence.

Summary

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510(K) SUMMARY

OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM

510(k) Number K_ / / / 00 / __________________________________________________________________________________________________________________________________________________

Applicant's Name:	Ophthalmic Imaging Systems221 Lathrop WaySuite ISacramento, CA 95815USATel: (916) 646-2020Fax: (916) 646-0207e-mail:aambrose@oisi.com
Contact Person:	Andrea Ambrose / Gil Allon221 Lathrop WaySuite ISacramento, CA 95815USATel: (916) 646-2020Fax: (916) 646-0207e-mail:aambrose@oisi.com or gallon@oisi.com
Manufacturing Site:	221 Lathrop WaySuite ISacramento, CA 95815USA
Date Prepared:	December 31, 2010
Trade Name:	OIS Symphony
Classification Name:	CFR classification section 892.2050 (product Code NFJ).
Classification:	Class II Medical Device

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Predicate Device:

OIS Symphony Image Management System is substantially equivalent to the following predicate devices:

(1) Zeiss Forum (K090439) Manufactured by Carl Zeiss Meditec Inc. is intended as a software system in storing, managing, and displaying patient data, diagnostic data, videos, and images from computerized diagnostic instruments through networks.

(2) Nidek Advanced Vision Information System (NAVIS) (K013694) manufactured by Nidek is a computer technology software that collects, stores, and maintains patient data information; providing real-time diagnostic patient information from a number of diagnostic ophthalmic instruments at any PC workstation. Navis contains core software that can be augmented by additional software modules, supporting the various applications used clinically.

Synergy (K093313) Manufactured by Topcon Medical Systems Inc. is a (3) comprehensive software platform intended for use in acquisition or importing. processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

Comparison of Technology with Predicates:

The OIS Symphony employs the same, or similar, technological characteristics as the predicate devices.

Device Description:

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Intended Use / Indication for Use: -

Performance Standards:

None. There are no mandatory performance standards for this type of device.

Test Data:

The OIS Symphony System has been subjected to extensive performance testing and validation before release. Final testing of OIS Symphony included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. See Section 9 for statement and declaration of conformity.

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Substantial Equivalence:

OIS Symphony is a comprehensive platform that collects, processes, measures, analyzes, and manages patient data and clinical information in an eye care environment. OIS Symphony provides a real time viewing environment for the collection and management of the patient demographics, image data, and clinical reports from a variety of approved medical devices, either directly or via a computer network. Similarly the predicate devices, including Zeiss Forum, NAVIS, and Topcon Synergy, are platforms for the import, acquisition, storage, and review of clinical images and tests of the eye, produced via a network or direct connection to the clinical instrument. The intended operators of OIS Symphony, similar to those of the predicate devices, are physicians (ophthalmologists), optometrists, ophthalmology technicians/ photographers. OIS Symphony and the predicate devices are used in environments that include hospital departments, ophthalmology clinics, and related medical facilities.

Conclusions:

The conclusions drawn from the above comparison to predicate devices is that OIS Symphony is substantially equivalent in safety and effectiveness to the predicate devices listed above.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written in bold, black letters. A line is drawn underneath the text. To the left of the text is a graphic of a symbol.

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

Ophthalmic Imaging Systems % Ms. Andrea Ambrose Quality Manager 221 Lanthrop Way, Suite I Sacramento, CA 95864

MAY 18 2011

Re: K110006

Trade/Device Name: OIS Symphony Image Management System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: NFJ Dated: May 11, 2011 Received: May 16, 2011

Dear Ms. Ambrose:

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 (reporting of medical

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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,
Debra Falls

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, 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): ★ // 0 0 0 k

Device Name: OIS Symphony

Indications for Use:

Prescription Use V (Per 21 C.F.R. 801 Subpart D) OR

Over-The-Counter Use (Optional Format Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110006

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).