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The Autotome Pro RX Sphincterotome is indicated for use in the selective cannulation of the Common Bile Ducts (CBD) and the transendoscopic sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi. The Sphincterotome can also be used to inject contrast medium.

The Autotome Pro RX Sphincterotome is used for cannulation of the bile duct when performing diagnostic and/or therapeutic endoscopic biliary procedures. The sphincterotome can deliver contrast medium to the distal tip yia an iniection channel to aid in fluoroscopic visualization. The sphincterotome consists of a cutting wire on the distal end to cut and cauterize the Papilla of Vater and/or Sphincter of Oddi when connected to a monopolar electrosurgical generator. The sphincterotome is designed for use with endoscopes that have a working channel of 2.8mm or larger.

The Autotome Pro RX Sphincterotome is a 200cm, triple lumen sphincterotome available in 2 sizes: 3.9Fr and 4.4Fr. The Autotome Pro RX 39 Sphincterotome is capable of accepting a 0.025" (0.64mm) guidewire and the Autotome Pro RX 44 Sphincterotome is capable of accepting a 0.035" (0.89mm) or 0.025" (0.64mm) guidewire. The Autotome Pro RX Sphincterotome includes insulation on the proximal end of the cut wire. The Autotome Pro RX Sphincterotome is also available with a pre-loaded guidewire.

The provided text is a 510(k) summary for the Boston Scientific Autotome Pro RX Sphincterotome. It details the device description, indications for use, and performance data from non-clinical bench testing, simulated use testing, and biocompatibility testing.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI/ML or human reader performance. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, which are standard for medical devices like sphincterotomes. There is no mention of:

• Acceptance criteria for AI/ML performance (e.g., sensitivity, specificity, AUC).
• A test set size or its provenance.
• The number or qualifications of experts for ground truth.
• Adjudication methods for ground truth establishment.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Training set size or ground truth establishment for a training set.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about studies involving AI/ML components or human reader performance, as this kind of data is not present in the provided document. The device in question is a physical medical instrument (sphincterotome), not a software or AI-driven diagnostic tool.

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