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The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX is intended to capture, display, store and manipulate images of the retina and the anterior segment of the eye, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.

The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NA VIS-EX ("AFC-330 with NA VIS-EX") is a conventional non-mydriatic auto fundus camera. The AFC-330 with NAVIS-EX captures fundus images using a built-in colour CCD camera without the use of mydriatic agents. With this single device, registration of patient information, image capture, and viewing of captured images are possible. By connecting a personal computer (PC) to the device via a LAN and installing the NA VIS-EX image filing system software, images captured by this device can be transferred to the PC and viewed and managed on the PC.

The provided text is a 510(k) summary for the Nidek Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical performance studies of AI/CADe devices.

The document states:

• Testing in support of substantial equivalence determination: "All necessary bench testing was conducted on the AFC-330 with NA VIS-EX to support a determination of substantial equivalence to the predicate devices. The performance testing included the following tests:
  • Electrical and mechanical safety testing
  • Electromagnetic compatibility testing
  • Light burden testing
  • Verification and validation testing"
• Summary: "The collective performance testing results demonstrate that AFC-330 with NA VIS-EX is substantially equivalent to the predicate devices."

This indicates that the submission relied on bench testing to demonstrate performance characteristics related to safety and fundamental functionality, rather than a clinical study evaluating diagnostic accuracy against specific performance metrics and acceptance criteria for an AI or CADe component. The device appears to be a traditional fundus camera with image filing software, not a product that performs automated diagnostic interpretations requiring acceptance criteria like sensitivity, specificity, or AUC based on expert reads.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving the device meets them because such information is not present in the provided text. The submission focuses on demonstrating substantial equivalence through standard device testing (safety, EMC, light burden, verification/validation) for a medical imaging acquisition and management system.

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