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The Wilson-Cook USW Needleknife Papillotome is intended for accessing the common bile duct when standard cannulation methods have been exhausted. The USW Needleknife Papillotome is supplied sterile and intended for single use only.

The proposed USW Needleknife Papillotome is a triple-lumen catheter, with one lumen dedicated to the cutting wire, wire guide access and contrast injection respectively. The wire guide lumen is compatible with a .035" wire quide. The 24 GA stainless steel cutting wire allows for the transfer of electric current enhance cannulation efforts when traditional cannulation efforts have been exhausted. The handle contains an electrocautery connection pin, which is compatible with a variety of active cords currently sold separately.

The provided text is a 510(k) summary for the Wilson-Cook USW Needleknife Papillotome. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the detailed information necessary to answer all the questions about specific acceptance criteria and the comprehensive study details (such as sample size for test sets, ground truth establishment, expert qualifications, or MRMC studies).

Based on the available information, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "Non-Clinical Testing was performed on characteristics of the USW Needleknife Papillotome deemed necessary to verify safety and performance." However, no specific acceptance criteria or quantitative performance results are provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available in the provided text. The document only mentions "Non-Clinical Testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not available in the provided text. This device is a medical instrument, not an AI or imaging diagnostic tool, so the concept of "ground truth" and expert review to establish it in the usual sense for diagnostic algorithms doesn't directly apply here. The "performance data" refers to non-clinical testing of the device's physical/functional characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/available. This is typically relevant for studies involving human interpretation or subjective assessment, which is not described for this device's non-clinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/available. This device is a surgical instrument, not an AI diagnostic tool, so an MRMC study is not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This question pertains to AI algorithms, which this device is not. The "Non-Clinical Testing" would assess the device's standalone physical and functional performance, but not in the context of an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not available/applicable in the traditional sense. For a medical device like a papillotome, "ground truth" for performance would likely revolve around objective engineering metrics related to its cutting ability, electrical conductivity, guidewire compatibility, mechanical integrity, and biocompatibility, as determined by a testing protocol. The summary does not provide these details.

8. The sample size for the training set

The device is a medical instrument, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The "Non-Clinical Testing" refers to laboratory or bench testing. No sample size for this testing is provided.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of medical device.

In summary, the provided document is a regulatory submission summary for a medical device and focuses on establishing substantial equivalence to a predicate device. It does not include the detailed scientific study breakdown typically provided for a diagnostic or AI-driven medical device, which would contain specific acceptance criteria, sample sizes, and ground truth methodologies.

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