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The Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q are intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.

The Single Use 2-Lumen Cannula V PR-V614M is intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.

The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series is comprised of nine (9) sterile, single-use, cannulas designed to inject contrast medium in the biliary or pancreatic duct when used in conjunction with a compatible endoscope.

Each device has two sections: the handle (proximal portion) and the insertion portion. The insertion portion is introduced into the biliary or pancreatic ducts through an endoscope. The distal end of the insertion portion is designed for smooth cannulation of the papilla of Vater or the minor papilla. All models are visible under fluoroscopy and feature a distal marking system.

The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series models are to be used with compatible endoscopes.

The provided 510(k) Premarket Notification document describes a medical device, the "Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series," and its comparison to a predicate device for demonstrating substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of device performance as typically expected for software-enabled devices or those with diagnostic capabilities.

This submission is for a physical medical device (cannulas) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of its physical properties and biocompatibility. Therefore, many of the requested categories (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to the information provided.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance data that was provided to demonstrate substantial equivalence, rather than specific and quantitative acceptance criteria with reported numerical device performance against those criteria. The "Analysis" column in the comparison table broadly states "Substantially equivalent" or "Identical," but doesn't provide the detailed numbers that would typically be associated with acceptance criteria for a diagnostic or algorithmic device.

Acceptance Criteria and Reported Performance (General statement from the document):

The document states: "Non-clinical testing demonstrates that the slight differences in device design do not alter the safety, efficacy, or performance of the subject devices when compared to the predicate devices." and "The non-clinical data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the identified predicate device." This is a qualitative conclusion of meeting equivalence rather than presenting specific numerical acceptance criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in the provided document. The performance data refers to various non-clinical tests, and the sample size for these individual tests (e.g., number of cannulas tested for insertion force) is not detailed.
• Data Provenance: Not applicable in the context of clinical data. The tests are non-clinical (laboratory/bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth as typically understood for diagnostic performance (e.g., disease presence/absence) is not relevant for these non-clinical, physical device performance tests. "Human Factors Testing" is mentioned, which would involve experts, but the number and qualifications are not provided, nor is it the type of "ground truth" establishment usually refers to in the context of diagnostic AI.

4. Adjudication method for the test set:

• Not applicable. This is typically used for clinical study endpoints or image interpretation, not for physical performance tests of a cannula.

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. This device is a physical cannula, not an AI or diagnostic imaging system.

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

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

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

• Not applicable in the conventional sense. The "ground truth" for the non-clinical tests would be the physical properties and functional performance measured against predefined specifications or predicate device performance.

8. The sample size for the training set:

• Not applicable for a physical device where "training set" doesn't apply in the context of machine learning.

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

• Not applicable for a physical device.

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