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The intended use of the miCOR 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.

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The provided text is an FDA 510(k) clearance letter for the miCOR System Lens Fragmentation System. This document, while indicating the device's clearance for market and its intended use, does not contain any information regarding specific acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information in the table or the subsequent numbered points based solely on the text provided. The document focuses on regulatory compliance and the determination of substantial equivalence, not on the detailed technical study results.

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The intended use of the xPORT 304 (miCOR) 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.

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The provided document, a 510(k) premarket notification letter from the FDA regarding the xPORT 304 (miCOR) System Lens Fragmentation System, does not contain any information about acceptance criteria or a study proving the device meets specific acceptance criteria.

The document details the FDA's clearance of the device for marketing, confirms its substantial equivalence to predicate devices, and outlines regulatory requirements. It also includes the device's indications for use: "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."

Without information directly related to performance studies, acceptance criteria, or their validation, I cannot provide the requested details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment method for the training set.

The document is purely a regulatory clearance notice, not a clinical study report or a technical performance specification.

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