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The VISUCAM C Digital Camera is intended for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented.

The VISCUCAM CM Digital Camerais intended to capture, display and store images of the eye, especially the retinal area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed. The VISCUCAM C™ Digital Camera is indicated for use in both mydriatic and non-mydriatic modes. As such, it acorporates appropriate light sources and filters so that images can be captured under both mydriatic and non-mydriatic conditions.

This document is a 510(k) summary for the Carl Zeiss Meditec AG VISUCAM™ C Digital Camera. It states that the device is substantially equivalent to previously marketed predicate devices. However, it does not contain the specific information required to answer the questions about acceptance criteria and a study proving the device meets those criteria. The provided text primarily focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results against predefined acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

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