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The Stryker Zyphr ™ Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick.

The Stryker Zyphr ™ Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.

The Zyphr TM Disposable Cranial Perforator is a mechanically powered tool specifically designed to rapidly create an access hole through the skull in a safe and reliable manner.

The provided text is a 510(k) summary for the Stryker Zyphr™ Disposable Cranial Perforator. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request for providing a table of acceptance criteria and reported device performance based on the input text, nor can I answer the specific questions about the study design. The document focuses on regulatory submission for substantial equivalence rather than detailing performance validation studies.

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