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The XK-95 Perforator Motor is intended to be used in conjunction with various cranial The XX-95 I criorator Motor adapter for cranial perforations.

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The provided text describes a 510(k) clearance letter for the Komet Medical Xk-95 Perforator Motor. This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that are typically found in a clinical study report.

Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory and not a performance-based assessment.

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High Speed Drall Syst પ્રાહ-95 for use during neurological to provide power to ope proc or attachments acı assurili

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The provided text is a clearance letter from the FDA for a medical device called the "XK-95 High Speed Motor Drill System." It confirms that the device is substantially equivalent to a previously marketed device. However, this document does not contain any information regarding:

• Acceptance criteria for the device's performance.
• Study details proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth was established.

This document is solely a regulatory approval letter based on "substantial equivalence" to a predicate device, not a performance study report. Therefore, I cannot fulfill your request for the specific information listed.

Ask a specific question about this device