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This device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. The device is supplied sterile and intended for single use only.

The proposed Locking Device is one-piece integrated system that secures onto the accessary channel of an endoscope. The access port in the center of the cap allows access of wire guides and other biliary accessories. The wire guide lock allows the practitioner to lock the wire guide in place for continued ductal access while proceeding with other ERCP therapies. This device consists of locking device and biopsy cap.

The provided text is a 510(k) summary for a medical device called "Locking device." It describes the device, its intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence to the FDA. However, the document does not contain information about acceptance criteria, specific performance metrics, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI devices.

Instead, it focuses on bench testing and biocompatibility for a physical medical accessory. Therefore, I cannot extract the requested information as it is not present in the provided text.

The information that is available includes:

• Device Name: Locking device
• Intended Use: An accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. Supplied sterile and intended for single use only.
• Predicate Device: Wilson-Cook USW Cap and Wire Lock (K040137)
• Performance Testing Mentioned:
  • Guidewire fixing force performance (for 0.025inch, 0.035inch, 0.038inch diameter guidewires)
  • Biocompatibility tests (In Vitro Cytotoxicity Test: ISO 10993-5:2009; Skin sensitization Test: ISO 10993-10:2010; Intracutaneous Reactivity Test: ISO 10993-10: 2010)
  • Manufacturing process for sterility (ISO 11135)

The document explicitly states: "No Clinical test is included in this submission."

Therefore, I cannot populate the table or answer the specific questions related to AI device performance evaluation as the document describes a purely mechanical medical device accessory.

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