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The TRC-NW8 is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without the use of a mydriatic.

This product is a retinal camera designed to observe, photograph or record the fundus oculi of a patient without coming into contact with the patient's eye and provide as an electronic image the obtained fundus oculi information for subsequent diagnosis. The TRC-NW8 can take both color photography and red-free photography. The TRC-NW8 is equipped with an observation monitor used for observation purpose and display of a photographed image. This product uses attached commercial digital single-lens reflex camera to photograph or record the fundus oculi of a patient. A photographed image may be recorded on a commercial memory card built into a commercial digital single-lens reflex camera or a personal computer (hereinafter referred to as a PC) or commercial memory devices (flash memories, hard disc, etc.). A commercial digital printer is connected and can print the observed images and the photographed images of the fundus.

The provided text does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, or accuracy), or a study that evaluates the device's clinical performance against such criteria.

The document is a 510(k) summary for the Topcon TRC-NW8 Non-Mydriatic Retinal Camera. It primarily focuses on demonstrating substantial equivalence to a predicate device (TRC-NW8F) and compliance with general safety and performance standards.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of clinical performance (e.g., image quality metrics or diagnostic accuracy). The acceptance criteria mentioned are related to compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2) and the results of a risk analysis assessment.
• Reported Device Performance: The document states that "Design verification tests were performed as a result of the risk analysis assessment. These test results demonstrated that the TRC-NW8 met predetermined acceptance criteria." However, no specific performance metrics or data (e.g., image resolution, diagnostic accuracy) are reported.

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

• Not provided. The document does not describe any clinical test set or data used to evaluate the device's performance in a diagnostic context. The testing mentioned appears to be engineering design verification for safety and fundamental requirements.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable/Not provided. Since no clinical test set is described, there's no mention of experts or ground truth establishment for diagnostic performance.

4. Adjudication Method:

• Not applicable/Not provided. No clinical performance study requiring adjudication is described.

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

• No. The document does not mention any MRMC study or a comparison of human reader performance with or without AI assistance. The device is a retinal camera, not an AI-powered diagnostic tool in this context.

6. Standalone (Algorithm Only) Performance Study:

• No. The device is a retinal camera for capturing images, not an algorithm for standalone diagnostic performance.

7. Type of Ground Truth Used:

• Not applicable/Not provided. No clinical study for diagnostic accuracy is described that would require a ground truth.

8. Sample Size for the Training Set:

• Not applicable/Not provided. The device is not an AI algorithm that requires a training set.

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

• Not applicable/Not provided. As above, no AI training set is mentioned.

Summary of available "Performance Data" from the document:

The "Performance Data" section solely refers to the device's compliance with electrical safety, EMC, and ophthalmic instrument-specific fundamental requirements and light hazard protection standards. It also states that design verification tests were performed as a result of risk analysis and that the results met predetermined acceptance criteria, but it does not detail those criteria or results in a clinical or diagnostic performance context.

This 510(k) summary focuses on the safety and fundamental performance characteristics of the hardware device (retinal camera) and its substantial equivalence to an existing device, rather than on the diagnostic or clinical accuracy of images or any integrated AI component.

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