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The World Wide Medical Technologies Anchor Marker and Marker Strand intended use is to, provide radiopaque markers for clearer identification of anatomic regions by providing reference positions around a proposed treatment site. They are indicated for use in brachytherapy, soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures

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The provided document is a 510(k) clearance letter from the FDA for a device called "Worldwide Medical Technologies, Anchor Marker, Marker and MarkerStrand." This type of document does not typically contain the detailed study information required to answer your questions about acceptance criteria and study design.

The 510(k) process primarily evaluates substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to establish safety and effectiveness for every submission. As such, the letter confirms clearance based on regulatory equivalency, not on a detailed analysis of performance against specific acceptance criteria from a new clinical study.

Therefore, I cannot extract the requested information regarding acceptance criteria and detailed study data from this document. This information would typically be found in the 510(k) submission itself, which is not publicly available in this format, or in associated scientific publications if such studies were performed and published.

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