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The Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and The Tracer Metro Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wilson-Cook's Tracer Metro Smart Wire Guide is intended to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ERCP.

The proposed Tracer Metro Smart Wire Guide is a modification to existing wire guides currently marketed by Wilson-Cock. The Tracer Metro Smart Wire Guide is .035" in diameter and is compatible with a full range of Wilson-Cook accessories.

I apologize, but the provided text does not contain the specific information required to complete a table of acceptance criteria and reported device performance, nor details about a comprehensive study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria and results.

Here's what I can infer from the text and why I cannot fully answer your request:

What the document does provide:

• Device Name: TRACER METRO SMART WIRE GUIDE
• Intended Use: "The Tracer Metro Smart Wire Guide is intended to assist in cannulation of the billary and pancreatic ducts and to aid in bridging difficult strictures during ERCP."
• Predicate Device: Wilson-Cook Wire Guide (k9910497)
• Basis for Clearance: Substantial equivalence to the predicate device.
• Statement on Performance Data: "We believe the proposed device to be substantially equivalent to the named predicate in terms of performance characteristics tested and biocompatibility."

What the document does not provide (and is needed for your request):

1. A specific table of acceptance criteria and reported device performance: The document states that the device is "substantially equivalent...in terms of performance characteristics tested and biocompatibility" but does not detail what these characteristics are, what the acceptance criteria for them were, or what the measured performance results were. This is common in 510(k) summaries where the focus is on equivalence, not necessarily on presenting a comprehensive performance study like a PMA submission might.

2. Details of "the study that proves the device meets the acceptance criteria": Since the acceptance criteria are not detailed, neither are the specifics of a study proving they were met. The document implies that some performance characteristics were tested to demonstrate substantial equivalence, but it doesn't describe the study design (sample size, data provenance, ground truth establishment, etc.).

Due to the limitations of the provided text, I cannot generate the detailed response you requested. If you have a document that specifically outlines performance studies with acceptance criteria and results, I would be happy to analyze it for you.

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