(135 days)
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.
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.
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):
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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).