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The Endoscopic Guidewire is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The Endoscopic Guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges of catheters, cannulas, and sphincterotomes.

The Taxi® Endoscopic Guidewire is a dual colored, spiral patterned guidewire. The quidewire is composed of a Nitinol core with a dual colored PTFE jacket applied over the core to provide endoscopic visualization of wire movement. A polyurethane/lungsten loaded jacket encapsulates the distal end and ensures radiopacity. The distal tip of the guidewire is coated with hydrophilic coating.

The provided text is a 510(k) Summary for the Taxi® Endoscopic Guidewire (K081708). This document outlines the device's characteristics and its substantial equivalence to a predicate device, rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way one would for an AI/ML-driven diagnostic device.

Therefore, many of the requested categories for defining acceptance criteria and study details are not applicable to the information provided. The document describes non-clinical tests to demonstrate safety and effectiveness for a medical device (guidewire), not a diagnostic algorithm.

Here's an attempt to extract relevant information where possible, and indicate where the requested information is not present in the provided text:

Acceptance Criteria and Device Performance (Limited Information available for a medical device, not a diagnostic algorithm):

Study Details (Not applicable for most items, as this is for a medical device's 510(k) submission, not an AI/ML diagnostic study):

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

   • Test Set Sample Size: Not specified in terms of specific number of guidewires tested, but "Test pieces" are mentioned.
   • Data Provenance: Not applicable. The testing was conducted by the manufacturer, Lake Region Manufacturing, Inc. (LRM).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to established engineering and material science standards for device performance, not expert labels for diagnostic images.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to resolving discrepancies in expert labeling for diagnostic studies.

4. 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 guidewire, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a guidewire, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this medical device's performance is based on established engineering requirements, material specifications (e.g., Nitinol core, PTFE jacket), and performance standards (e.g., ISO 10993 for biocompatibility). The document states, "Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes."

7. The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML model.

8. How the ground truth for the training set was established: Not applicable. This device does not involve a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was a series of non-clinical tests performed by Lake Region Manufacturing, Inc. (LRM). These tests assessed the device's functionality, performance characteristics, and biocompatibility.

• Non-Clinical Tests: "LRM performed testing to established requirements. Test pieces were tested and inspected according to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes." The conclusion was that "The results of these tests demonstrated the functionality and performance characteristics of these Guidewires are comparable to the similar currently marketed devices."
• Biocompatibility Testing: "Biocompatibility testing per ISO 10993 series has been performed on the Taxi® Endoscopic Guidewire and has been found to be acceptable."

The overall conclusion states that the device is "substantially equivalent" to the predicate device (JAGWIRE™ RECANALIZATION GUIDEWIRE K922302) based on these non-clinical evaluations. This substantial equivalence determination by the FDA indicates that the device is considered safe and effective for its intended use without requiring a full clinical trial for approval.

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