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The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches.
ETHIBOND EXCEL Polyester Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) have not changed in design or manufacture from 510(k) #972679.

This document (K980022) is a 510(k) summary for the ENDOPATH® Endoscopic Tissue Fastening System (ETFS). It explicitly states that the device's design, materials, physical properties, intended use, indications statement, technological characteristics, and performance have not changed from the previously cleared device (K972679).

Therefore, the document does not contain information regarding acceptance criteria or a study proving device performance for this specific submission. Instead, it relies on the substantial equivalence to the predicate device.

To answer your questions, one would need to review the K972679 submission for the performance data and acceptance criteria of the original device.

Without that predicate device information, I cannot provide a detailed answer to your specific requests about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

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