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This device is used for motility studies in the common bile duct, pancreatic duct, Sphincter of Oddi and duodenum.

The Lehman Manometry Catheter is a modification to the Wilson-Cook Biliary Motility Catheter currently cleared to market via 510k K900058 by Wilson-Cook Medical, Inc. The modified manometry catheter is compatible with a .018" inch wire guide and available in a 200 cm length with a 5 mm short tip or 15 mm long tip configuration. The catheter features include 1 mm marks at the distal end that provide reference points to the .023" inch perfusion and aspiration side ports and to indicate movement of the catheter while in use. The proximal end consists of three lumen color coded leads that provide access to the side ports and wire guide lumen. The red is designated to the proximal side perfusion port, the yellow is for the distal side perfusion port and the green leads to the middle aspiration or through the end of catheter wire guide ports.

I apologize, but this document does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study that proves a device meets those criteria.

The provided text is a 510(k) clearance letter from the FDA for a device called the "Lehman Manometry Catheter." It primarily focuses on the regulatory determination of substantial equivalence to a predicate device.

Here's a breakdown of why I cannot extract the requested information from this document:

• No specific acceptance criteria are listed. The document mentions that the device is substantially equivalent and that design validation/verification testing was performed, but it does not specify what those acceptance criteria were (e.g., specific performance thresholds, accuracy metrics, etc.).
• No detailed study results or methodology are provided. While it states that "Design verification and/or validation testing was performed," it does not include any information about the study design, sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods for either training or test sets. It also doesn't mention MRMC comparative effectiveness studies or standalone algorithm performance.

In summary, this document is an FDA clearance letter, not a detailed technical report or study publication that would contain the specific performance data and study design details you are asking for. It confirms that the manufacturer performed testing and the FDA found the device substantially equivalent, but it does not disclose the specifics of that testing or the performance metrics against acceptance criteria.

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