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SourceLink™ Brachytherapy Seeding Spacer Links are intended for spacing and linking brachytherapy seeds to be used in brachytherapy procedures.
SourceLink™ Connectors are indicated for use in seed spacing and linking in brachytherapy procedures.

SourceLink™ Brachytherapy Seeding Spacer Links have been designed to accurately space seeds in 0.5cm increments center-to-center during brachytherapy implant procedures. Seeds are 0.8mm in diameter and friction fit into the open female ends of the SourceLink™ Brachytherapy Seeding Spacer Links. The friction fit ensures the spacing between seeds will be accurately maintained during the implant procedure. The SourceLink ™ Brachytherapy Seeding Spacer Links are compatible by design with commonly used implant needles.

The provided text describes a medical device, the SourceLink™ Brachytherapy Seeding Spacer Links, and its 510(k) summary for FDA clearance. However, it does not contain any information about specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document states: "The appropriate design verification and validation activities for the modification of the SourceLink™ Brachytherapy Seeding Spacer Links was conducted." but provides no details on what those activities were, what the acceptance criteria for those activities were, or what the results were.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I fill in a table of acceptance criteria and reported device performance, or answer any of the subsequent detailed questions.

The document is purely a regulatory submission stating the device's substantial equivalence to a predicate device based on its intended use, design, and fundamental scientific technology, without elaborating on performance data.

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