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This device is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.

The Acrobat Calibrated Tip Wire Guide is a modification to the existing Endoscopic Wire Guides currently marketed by Wilson-Cook Medical, Inc. The modified wire guide is compatible with a .025", .035" inch or larger inner diameter accessory and available in 205cm, 260cm and 450cm lengths. The wire guide features include marks at 5cm to 25cm at the distal end that provide reference points to indicate movement of wire guide while in use. The distal tip consists of an 11.5cm or 27cm hydrophilic slip-coating.

The provided document is a 510(k) premarket notification for a medical device (Acrobat Wire Guide) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way one would expect for a study proving device meeting acceptance criteria.

The document primarily states:

• Device: Acrobat Wire Guide
• Purpose: To assist in cannulation of biliary and pancreatic ducts and aid in bridging difficult strictures during ERCP.
• Comparison: It is a modification of an existing device (Endoscopic Wire Guide, K122816).
• Performance Data: "Design verification and/or validation testing was performed as a result of this risk analysis assessment. Results from design validation and/or verification testing provided reasonable assurance that the modified device is as safe and effective as the predicate device."
• Conclusion: The device is "substantially equivalent to the named predicate in terms of its intended use, performance characteristics tested."

Therefore, based solely on the provided text, the specific details required for your request (tables of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) are not present.

The document discusses "design verification and/or validation testing" and "risk analysis," which are general terms in medical device development. It does not provide the results or the specific criteria used in these tests for the Acrobat Wire Guide.

If this were a document about a new, novel AI device, it would typically contain the requested information in much greater detail. However, this is a 510(k) for a modified guidewire, where the focus is on demonstrating that the modifications do not negatively impact safety and effectiveness compared to an already cleared device, rather than a full de novo performance study.

To answer your request based on the absence of information:

1. Table of acceptance criteria and reported device performance: Not provided in the document. The document states "Results from design validation and/or verification testing provided reasonable assurance that the modified device is as safe and effective as the predicate device," but no specific criteria or performance values are reported.
2. Sample size used for the test set and data provenance: Not provided. The document mentions "Design verification and/or validation testing" but does not detail the sample sizes or data sources.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable/Not provided. The document does not describe studies involving human readers or ground truth establishment in this context.
4. Adjudication method: Not applicable/Not provided.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable/Not provided. This type of study is more relevant for diagnostic imaging devices with AI assistance, not typically for a wire guide.
6. Standalone (algorithm only) performance: Not applicable/Not provided. This is a physical device, not a software algorithm in the context of standalone performance.
7. Type of ground truth used: Not applicable/Not provided. The "testing" referred to for this device would likely involve mechanical and material property testing, rather than establishing a clinical "ground truth" as you might see for a diagnostic device.
8. Sample size for the training set: Not applicable/Not provided. This device (a guidewire) does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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