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Intended to be a reusable instrument to provide the physician with a means for direct viewing of the nasal cavity by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures.

Ecleris Sinuscope

This document is a 510(k) premarket notification letter from the FDA for the Ecleris Sinuscope. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document does not contain the information requested in points 1-9.

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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.

Not Found

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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