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The intended use of the MICOR® 700 Lens Removal System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

It appears there has been a misunderstanding. The provided FDA 510(k) clearance letter for the MICOR 700 System is for a Phacofragmentation System, which is a medical device used for surgery, specifically for cataract removal.

This document does NOT contain information about any AI/ML-based device, nor does it detail acceptance criteria, study data, ground truth establishment, or sample sizes related to AI/ML performance.

Phacofragmentation systems are mechanical and electronic devices, and their "performance" criteria are typically related to:

• Power output and control: How effectively and safely they fragment the lens.
• Aspiration rate and vacuum control: How efficiently they remove fragmented lens material.
• Irrigation flow: Maintaining proper eye pressure during the procedure.
• Safety features: Overpressure limits, heat generation, sterile components.
• Biocompatibility: Materials used.

Therefore, I cannot fulfill your request for information regarding AI/ML device acceptance criteria and study details based on this document. The information you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is relevant to the evaluation of AI/ML algorithms, not to a traditional surgical device like the MICOR 700 System.

If you have a document describing an AI/ML-based medical device, I would be happy to analyze it according to your requested criteria.

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