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Reprocessed guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.

Reprocessed guidewires are constructed utilizing a metal alloy that is encapsulated in a striped covering and contains a radiopaque tip. The guidewires are manufactured in a wide range of diameters, lengths, tip angles, and stiffness.

This document is a 510(k) clearance letter from the FDA for reprocessed guidewires. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to predicate devices. It does not contain the detailed information needed to answer your questions about acceptance criteria and a specific study proving the device meets those criteria.

Here's a breakdown of why I cannot fully answer your request based on the provided text:

• No detailed acceptance criteria or performance study: The document states that "Reprocessed guidewires underwent bench testing to demonstrate appropriate functional characteristics" and that "Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging." However, it does not provide specific acceptance criteria, performance metrics, or the results of these tests. It only concludes that the device is "substantially equivalent."
• Focus on substantial equivalence, not detailed performance: The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving absolute safety and effectiveness through detailed studies with predefined acceptance criteria and performance reports in the same way a PMA (Premarket Approval) process would.

Therefore, I cannot provide the requested table or answer most of your detailed questions.

What I can infer or state based on the document:

• Device Name: Reprocessed Guidewire
• Intended Use: For selective cannulization of the biliary ducts (common bile, cystic, right and left hepatic ducts) during endoscopic biliary procedures for catheter introduction and exchanges.
• Predicate Devices: Jagwire™ guidewire (K922302) by Microvasive, and FlexFinder® Guidewire (K964955) by FlexMedics.
• Regulatory Clearance: 510(k) (K012556)
• Testing Mentioned (without details): Bench testing for functional characteristics, process validation for cleaning, sterilization, and packaging, and in-process visual and functional testing.

The information you requested that is not in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (effect size, human readers improvement).
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

To obtain this specific information, you would typically need access to the full 510(k) submission, which includes detailed test reports and validation studies not summarized in this clearance letter.

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