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The XTJF-160AF has been designed to be used with an Olympus EVIS video system center, light source, Documentation Equipment, Video Monitor, Endo-Therapy accessories (such as a Forceps, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.

Do not use these instruments for any purpose other than their intended uses.

This premarket notification is proposed to establish the safety and effectiveness of the variable stiffness scope that is intended for endoscopy and endoscopic surgery, including electrocautery application, within the duodenum. The intended use of the XTJF-160AF is identical to that of previously cleared device, the TJF-140R and JF-V10. The mechanical structure of variable stiffness is identical to that of another predicate device, the EVIS EXERA Colonovideoendoscopes. While the variable stiffness scope is brand new device in the duodenum, endoscopy and endoscopic surgery, including electrocautery, within the duodenum is popular and the mechanical structure of variable stiffness has been confirmed to be safe by the EVIS EXERA Colonovideoendoscopes. Any new insertion method or techniques in consequence of the added mechanical structure of variable stiffness are not considered. Therefore, this modification does not affect the safety and effectiveness of the proposed device,

XTJF-160AF has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-2 and IEC60601-2-18.

There are no new patient contacting materials. All of patient contacting materials is cleared by previous 510(k). And all materials have been confirmed with ISO 10993-1.

The provided document is a 510(k) summary for the Olympus XTJF-160AF Duodenovideoscope. It discusses the device's substantial equivalence to previously marketed devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence based on:

1. Intended Use: The intended use of the XTJF-160AF is identical to previously cleared devices (TJF-140R and JF-V10).
2. Mechanical Structure: The variable stiffness mechanism is identical to another predicate device (EVIS EXERA Colonovideoendoscopes), which has already been deemed safe.
3. Materials: No new patient-contacting materials are used, and all materials have been cleared by previous 510(k)s and confirmed with ISO 10993-1.
4. Safety Standards: The device complies with IEC60601-1, IEC60601-1-2, and IEC60601-2-18.

Therefore, I cannot populate the requested table or answer the specific questions about studying device performance as this information is not present in the provided text.

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