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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, pancreatic, cystic, right and left hepatic ducts. The endoscopic guidewire is designed to be used during endoscopic pancreatic -biliary procedures for catheter introduction and exchanges of catheters, cannulas and sphicterotomes.

Utilizing proprietary processes, these guides are constructed from a steerable, metallic core (Witinol) with a polymer jacket (polyurethane) coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Guidewires are available in 260cm length and in diameters 0.018", 0.025" depending on specific design requirements. Guidewires may have a straight or a pre-shaped distal tip and are available in different tip flexibilities, which are dependent on the grind configuration of the core.

The provided text describes a 510(k) submission for the NaviPro™ Guidewire. The acceptance criteria and the study proving the device meets these criteria are related to non-clinical performance testing and biocompatibility, as this is a medical device approval. The document states that the device is "substantially equivalent" to predicate devices, meaning it does not claim superiority, but rather equivalent safety and effectiveness based on similar design and performance.

Here's an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and corresponding performance results. Instead, it broadly states that testing was performed to establish requirements and demonstrate functionality.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "Test pieces were tested and inspected," but does not quantify how many pieces were in the test set.
• Data Provenance: The studies are described as "non-clinical" and "biocompatibility testing," suggesting laboratory-based testing rather than human subject data. The manufacturer is Lake Region Medical, located in Chaska, MN, USA, implying the testing was conducted or overseen by them. No mention of retrospective or prospective data in a clinical sense, as it refers to device performance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable in the context of this 510(k) submission. The "ground truth" for a medical device like a guidewire is established through engineering and material science testing against predefined specifications and industry standards (e.g., ISO standards like 10993, 11070, 15223, EN 980, ISO 594, which the device is stated to comply with). It doesn't involve expert consensus on medical images or patient outcomes in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies where human interpretation is involved. For non-clinical device performance testing, the "adjudication" is based on meeting engineering specifications and test methodologies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of how much human readers improve with AI vs. without AI assistance. This type of study is relevant for AI-powered diagnostic devices, not for basic medical devices like guidewires.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a guidewire, a physical medical instrument, not an algorithm. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, industry standards (e.g., ISO), and comparison to functionally equivalent predicate devices. The non-clinical testing "demonstrate[d] the device is as safe, as effective and performs as safely and effectively as the legally marketed device."

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the machine learning sense. The development process would involve iterative design, prototyping, and testing, but not machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this physical medical device.

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