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The intended use of the Ultraclip II WING and Ultraclip II COIL is to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

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I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, study details, or performance metrics of the device (Ultraclip® II WING, Ultraclip® II COIL).

The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device. It confirms that the device can be marketed but does not include the detailed study results or acceptance criteria that would typically be found in a clinical study report or a more comprehensive submission document.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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