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The EasyPass Guidewire is used for selective cannulation of the biliary ducts including, but not limited to the common bile duct, cystic duct, and right and left hepatic ducts. The EasyPass guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.

The EasyPass Guidewire consists of a Nitinol core wire with a proximal 2-color spiral patterned PTFE jacket and a copolymer distal section. The distal stainless steel spring section of the guidewire provides flexibility and incorporates a hydrophilic coating. The EasyPass Guidewire is a sterile packed, disposable instrument intended for single-patient use only.

This document is a 510(k) premarket notification for the EasyPass Guidewire. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where specific acceptance criteria are defined and statistically proven.

Therefore, the requested information cannot be fully provided in the typical format for a study proving device meets acceptance criteria. However, I can extract the relevant information regarding the performance data provided.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, "acceptance criteria" are not explicitly stated in a quantitative manner with pass/fail thresholds for specific performance metrics in the way one might expect for a de novo or PMA submission. Instead, the performance is demonstrated by comparing the device to a predicate and showing it meets "the same performance requirements." The "acceptance criteria" are therefore implicitly that the device performs equivalently to the predicate device in the specified tests.

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

The document does not specify the exact sample sizes (N) used for each non-clinical performance test. It only states that these tests were conducted. The data provenance is "non-clinical performance data" generated from bench testing and biocompatibility assessments of the proposed EasyPass Guidewire. There is no information regarding the country of origin or whether it's retrospective/prospective as these are not clinical tests.

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

Not applicable. This document describes non-clinical testing (bench and biocompatibility), not studies involving expert evaluation of clinical data or images.

4. Adjudication method for the test set

Not applicable. No expert adjudication was described for these non-clinical tests.

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 medical guidewire, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.

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

Not applicable. This device is a medical guidewire, not an algorithm.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" would be established by the standardized methods and specifications relevant to each test (e.g., ISO 10993 for biocompatibility, material specifications for fracture/bend/tensile tests, etc.). The goal was to demonstrate performance equivalent to the predicate device.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. (See #8)

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