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The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The Micrus Cashmere-Cerecyte and Cashmere-SR Microcoil Systems each consists of an embolic coil (“Microcoil”) attached to Device Positioning Unit (DPU) (single use, sterile)

This document describes a 510(k) premarket notification for the Micrus Microcoil Delivery System and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, I cannot fulfill the request to provide information based on acceptance criteria and a study from the provided text.

Here's why the prompt cannot be answered with the given text:

• Type of Submission: The document is a "Summary of Safety and Effectiveness" for a 510(k) submission. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, predefined acceptance criteria through a clinical or performance study.
• Content Focus: The text explicitly states, "Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the Micrus Cashmere-Cerecyte and Cashmere-SR Microcoil Systems are substantially equivalent to the predicate devices in safety and effectiveness." This indicates that the "study" was primarily a comparison to existing devices and non-clinical testing, not a formal study with acceptance criteria being met.
• Missing Information: The document lacks the detailed information requested in the prompt, such as:
  • Specific acceptance criteria values.
  • Quantitative performance results for the new device against those criteria.
  • Sample sizes for test sets, data provenance, ground truth establishment, expert information, adjudication methods, MRMC studies, or standalone algorithm performance.
  • Training set details.

In summary, the provided text is a regulatory clearance document for a medical device based on substantial equivalence, not a detailed report of a study designed to meet specific acceptance criteria.

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