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Used to remove stents from the biliary and pancreatic duct(s) while maintaining wire guide placement.

The modified Soehendra Stent Retriever (subject device) represents modifications made to the Soehendra Stent Retriever (predicate device) currently cleared to market via 510k: K903420 by Wilson-Cook Medical, Inc. The subject device consists of a knob-like handle and irrotational 7 Fr diameter cable available in 183 cm total length (168 cm working length, the portion of cable that fits inside endoscope channel) with a tapered threaded screw type distal tip configuration. The subject device is compatible with a .018" or .035" wire guide and is available with 5, 7, 8.5, 10 or 11.5 Fr tip diameters. The various tip diameters are offered in order to facilitate the removal of different size plastic biliary and pancreatic stents. The subject device is used by placing the cable through an endoscope over a prepositioned wire guide that has been passed through the stent lumen. The tip is screwed into the subject device and stent are removed through the endoscope. If necessary, the wire guide can be left in place to allow placement of a new stent.

The provided document is a 510(k) premarket notification for a medical device called the "Soehendra Stent Retriever." It discusses the device's indications for use, description, and substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria, a study proving device performance against such criteria, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document primarily focuses on FDA regulatory approval through the 510(k) pathway, which establishes substantial equivalence to a legally marketed predicate device rather than providing extensive clinical performance data against specific acceptance criteria.

The "Performance Data" section states: "The Risk Analysis was completed to access the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method. Design verification and/or validation testing was performed as a result of this risk analysis assessment. Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness." This indicates that engineering verification and validation were performed to confirm the device meets its design specifications and that the modifications do not introduce new risks, but it does not detail clinical study performance against predefined acceptance criteria for accuracy, sensitivity, specificity, etc.

Therefore, I cannot provide the requested information.

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