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Intended to magnify the view of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy.

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The provided document is an FDA 510(k) clearance letter for the Ecleris Microstar colposcope (K100595). This document primarily focuses on establishing substantial equivalence for a physical medical device (colposcope) and does not contain the kind of information requested about acceptance criteria and a study proving a device meets them, especially in the context of an AI/algorithm-based device.

Therefore, I cannot extract the requested information from the provided text. The document does not discuss:

• Acceptance criteria table and reported device performance.
• Sample size for test sets, data provenance, number of experts for ground truth, or adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect size of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes, expert consensus).
• Sample size for training set or how its ground truth was established.

This document is concerned with the regulatory clearance of a physical medical device (a colposcope), not AI or algorithmic performance.

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