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The Anchor Tissue retrieval system is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

The Anchor Tissue retrieval system is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

This document does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria, device performance, and the specifics of a validation study (such as sample sizes, ground truth establishment, or expert qualifications).

The document is an FDA 510(k) clearance letter for the "Anchor Tissue Retrieval System." It confirms that the device is substantially equivalent to a legally marketed predicate device. However, it does not include:

• Acceptance Criteria Table: There is no specific table outlining performance metrics and their acceptance thresholds.
• Reported Device Performance: While the letter implies the device met the necessary criteria for substantial equivalence, it does not provide quantitative performance data.
• Details of a specific study: The letter refers to the "review of your Section 510(k) premarket notification" but does not detail the studies submitted within that notification, nor does it specify sample sizes, data provenance, ground truth methods, expert qualifications, or comparative effectiveness study results.
• Training set details: No information about a training set is provided.

In summary, the provided text confirms FDA clearance but lacks the technical details of the underlying validation studies to answer your specific questions.

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