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Used to gain precise percutaneous access to the kidney by means of controlled fine wire puncture from within the collecting system for patients aged 12 years and older.

The Lawson Retrograde Nephrostomy Wire Puncture Set is used to gain percutaneous access to the kidney by means of a controlled fine wire puncture from within the collecting system.

The Lawson Retrograde Nephrostomy Wire Puncture Set is composed of the tipdeflecting wire guide, catheter, sheathed puncture wire, coaxial needle assembly (inner and outer needle cannulae) and working wire guide. The tip-deflecting wire guide is used to direct the catheter into the desired calyx in a retrograde manner using standard access techniques, followed by exchange of the deflecting wire with the sheathed puncture wire. To initiate percutaneous nephrostomy access, the puncture wire is unsheathed and advanced from the catheter through the kidney towards the patient's flank and through the skin. The coaxial needle assembly is then advanced over the puncture wire and into the renal collecting system, and then the puncture wire and inner needle cannula are removed to allow a working wire guide to be placed through the outer needle cannula.

• . The tip-deflecting wire guide has a three-ring handle which twist-locks with the catheter. The tip-deflecting wire guide is made from stainless steel and is available in an outer diameter of 0.045 in.
• . The catheter is available in an outer diameter of 7 Fr with a length of 82.5 cm and made of braided nylon tubing. The sheathed puncture wire can interlock with the proximal portion of the catheter.
• The sheath is made of radiopaque TFE tubing which extends 1 cm from the . catheter when locked together. The sheath is available in an outer diameter of 3 Fr with a length of 85 cm.
• . The puncture wire is made of stainless steel with a plastic pin vise handle. The puncture wire has an outer diameter of 0.43 mm with a length of 145 cm.
• . The needle set has a 22 gage inner needle that is 22.5 cm in length with the outer needle being 18 gage and 14 cm in length.
• . The working wire guide is made of stainless steel and is 0.97 mm in diameter and 145 cm in length.

The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

The provided text describes a medical device, the Lawson Retrograde Nephrostomy Wire Puncture Set, and its 510(k) submission to the FDA. However, the document does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of AI/ML or diagnostic performance.

The performance data listed refers to engineering and biocompatibility tests for a physical medical device, not a diagnostic algorithm or AI system. Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details, human reader performance, or ground truth for an AI-based device.

The "Performance Data" section lists the following tests:

• Biocompatibility
• Compatibility (likely referring to component compatibility)
• Dimensional
• Tensile Strength (Hub-to-Shaft Bond of Catheter, Sheath, Stylet, Needles; Tip-to-Shaft Bond of Catheter; Distal Tip of Deflecting Wire; Shaft of Puncture Wire)
• Radiopacity
• Shelf Life following Accelerated Aging to Three-year Real-Time Equivalency
• Packaging, Sterility and Stability

These are standard tests for physical medical devices to ensure safety, functionality, and manufacturing quality. The document concludes: "All predetermined acceptance criteria of the testing were met. Therefore, the results of these tests support a conclusion that the Lawson Retrograde Nephrostomy Wire Puncture Set will perform as intended and support a determination of substantial equivalence to the predicate device."

Since the provided text does not describe an AI/ML device or its associated performance study, I cannot fill out the requested table or answer the questions related to AI performance, expert adjudication, or training/test sets for an AI model.

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