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The Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.

The Galileo Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.

The Leisegang Video Colposcope consists of a CCD camera with a halogen light source, green filter and is mounted on a mobile base.

This 510(k) summary (K981958) is for the Leisegang Video Colposcope. It describes the device's intended use and compares it to predicate devices. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence rather than performance data. The device is a direct viewing instrument, not an AI/algorithm-driven device, which means the requested parameters (e.g., sample size for training set, MRMC studies, ground truth) are not applicable to the information provided in this 510(k) summary.

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