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Wilson-Cook's Tri-Tome Select Plus Sphincterotome is intended for cannulation of the ductal system and for sphincterotomy.
Used for cannulation of the ductal system and for sphincterotomy.

The proposed Tri-Tome Select Plus Sphincterotome is a triple-lumen sphincterotome. It is capable of accommodating a .035" wire guide while allowing simultaneous injection of contrast media through separate lumens.

The provided document is a 510(k) summary for the Wilson-Cook Tri-Tome Select Plus Sphincterotome. It declares the device to be substantially equivalent to predicate devices based on performance characteristics and biocompatibility. However, it does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.

Here's what can be extracted and what is not available from the provided text:

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

This information is not provided in the document. The document states:

"We believe the proposed device to be substantially equivalent to the named predicates in terms of performance characteristics tested and biocompatibility."

This suggests that performance testing was conducted, but the specific acceptance criteria, numerical performance metrics, and a comparison table are absent.

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

This information is not provided. The document does not mention sample sizes for any testing, nor does it describe the nature or origin of the data.

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 information is not provided. The assessment appears to be based on the device's physical characteristics and its intended use compared to predicate devices, rather than an expert-driven evaluation with a "ground truth" as might be seen for diagnostic AI.

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

This information is not provided.

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 is not applicable as the device is not an AI diagnostic tool that assists human readers. It is a medical instrument (sphincterotome). Therefore, an MRMC study is not relevant here.

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

This is not applicable as the device is not an algorithm or AI.

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

This information is not provided and is not directly relevant for this type of device submission. The "ground truth" in this context would likely be engineering specifications, material properties, and functional tests demonstrating safety and technical performance, which are not detailed in this summary.

8. The sample size for the training set:

This is not applicable as the device is not an AI system that requires a training set.

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

This is not applicable as the device is not an AI system that requires a training set.

In summary: The provided document is a 510(k) summary for a medical device (a sphincterotome) focused on establishing substantial equivalence to existing predicate devices. It does not contain the detailed performance study information, acceptance criteria, sample sizes, expert ground truth, or AI-specific study details that your request outlines. This type of information is typically found in more extensive technical reports or test protocols, which are not part of this summary document.

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