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The OVision Imaging System is a software program that is intended for use in the collection, storage, and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments.

The software system is indicated for use with retinal camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps.

The OVision Imaging System is a software system that collects, stores, and maintains images of the retina and anterior segment of the eye. The Ovision Imaging System is used together with retinal cameras or digital camera imaging devices.

In operation, the retinal camera will be operated as normally intended, with the OVision Imaging System capturing images of the patient. The OVision Imaging System does not alter or control the parameters of the retinal camera.

The OVision Imaging System software accessory captures images from USB or Firewire digital cameras that are commercially available for both color and monochromatic imaging. The digital camera output of the fundus camera is tethered to the commercially available computer via a USB or FireWire cable.

The OVision Imaging System software system receives the images captured by the retinal camera or digital camera. The images are stored in the computer's random access memory (RAM) and then saved on the local storage of the computer. The patient and exam information are stored in the system's database.

The OVision Imaging System attaches directly to an existing retinal camera or digital camera via a communication cable. The user is able to operate the fundus camera in the manner it was intended, either viewing and focusing on the patient's retina through the eye piece or through the external monitor. During operation, the digital camera will transfer captured images to the computer to then store on its local drive.

It is not possible to provide acceptance criteria and detailed study information because the provided text is a 510(k) summary for a Picture Archiving and Communications System (PACS) device. This type of device, as per 21 CFR 892.2050, is generally focused on image management, storage, and display, rather than providing diagnostic interpretations or measurements that would require specific performance metrics like sensitivity or specificity.

510(k) summaries for PACS devices without advanced diagnostic algorithms typically focus on demonstrating substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety and effectiveness. The "Non-Clinical Performance Data" section explicitly states: "Performance testing was performed on the OVision Imaging System during software verification and validation. During verification, the OVision Imaging System was found to meet the requirements, and during validation, the OVision Imaging System was found to perform as intended." This indicates general software testing, not a clinical study to assess diagnostic performance against specific acceptance criteria.

Therefore, the requested information (acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type and training set details) is not applicable to the information provided in this 510(k) summary. These details would typically be found in submissions for AI-powered diagnostic devices or those making specific claims about image analysis beyond basic management and display.

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