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The Wilson-Cook Needle Knife Papillotome is used for accessing the common bile duct when standard cannulation methods have been exhausted. This device is supplied sterile and is intended for single use only.

The Wilson-Cook Needle Knife Papillotome consists of a single lumen tubing, 23 gauge needle, and a papillotome handle. This device is designed for insertion through the accessory channel of an endoscope. The catheter is advanced through the accessory channel positioning the needle knife near the papillary orifice. The device is connected to an electrocautery unit via an active cord. The current from the electrocautery unit is passed through the cutting wire to the distal end of the papillotome thus allowing the needle knife to make small incisions in the papilla. Once the appropriate incision has been made the needle knife may be retracted allowing cannulation of the biliary tree.

The provided documents describe the Wilson-Cook Needle Knife Papillotome and its 510(k) submission. However, the information available is limited regarding acceptance criteria and a structured study proving the device meets these criteria. Medical device 510(k) submissions, especially from this era (1997), typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies with detailed acceptance criteria as one might expect for a novel AI device today.

Based on the provided text, here's what can be extracted and what is missing:

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

Missing Information: Specific quantitative acceptance criteria (e.g., "tensile strength must be > X N," "insertion force must be < Y N," "failure rate for particular function must be < Z%"). The document states "test specifications were met" but does not detail what those specifications were.

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

• Sample Size: The document states "Samples were subjected to visual, dimensional, and functional analysis." However, the exact number of samples used for this functional and dimensional testing is not specified.
• Data Provenance: Not applicable in the context of device testing described. The testing appears to be internal engineering and bench testing, not clinical data from patients. There is no mention of country of origin or whether a retrospective/prospective study was conducted for performance evaluation.

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)

• This question is not applicable as the document describes a physical medical device (papillotome) and its engineering/bench testing for substantial equivalence, not an AI or diagnostic device that requires expert consensus for ground truth establishment.

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

• This question is not applicable for the same reasons as point 3. There is no mention of adjudicating expert opinions for a test set.

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

• This question is not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool.

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

• This question is not applicable. This is not an algorithm or AI device.

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

• For the physical attributes and performance (e.g., sterility, biocompatibility, functional testing), the "ground truth" would be established by engineering specifications, validated test protocols, and recognized standards (like AAMI for sterility) rather than clinical ground truth (pathology, expert consensus). Biocompatibility was established by "history of use in other similar medical devices," which serves as a form of established safety.

8. The sample size for the training set

• This question is not applicable. There is no "training set" as this is not an AI/algorithm device.

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

• This question is not applicable. There is no "training set" as this is not an AI/algorithm device.

Summary of Device and Evidence:

• The Wilson-Cook Needle Knife Papillotome is a surgical instrument used to access the common bile duct.
• The 510(k) submission focused on demonstrating substantial equivalence to a predicate device (ENDOVATIONS, INC. .035" PRE-CUT NEEDLE KNIFE) by comparing intended use and key device characteristics (materials, dimensions, sterility).
• Evidence for meeting general safety and effectiveness relied on internal "functional testing conducted per approved protocol," visual and dimensional analysis, and validation of sterility processes. Biocompatibility was established by prior use of similar materials.
• The document does not contain details typical of an AI device submission, such as specific performance metrics like sensitivity/specificity for a diagnostic task, expert review, clinical study data with patient outcomes, or detailed sample sizes for such studies. The regulatory approval (K972674) was based on a finding of substantial equivalence.

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