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The instrument is designed to be used to provide access to lesions to be biopsied.

Coaxial Introducer

This document is an FDA 510(k) clearance letter for the "Coaxial Introducer" and does not contain the acceptance criteria or study details requested in the prompt.

The letter explicitly states:

• Trade Name: Coaxial Introducer
• Regulatory Class: II
• Product Code: KNW
• Indications for Use: The instrument is designed to be used to provide access to lesions to be biopsied.
• Date of Clearance: July 29, 1997

The letter confirms that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This is a regulatory determination, not a clinical performance study. The letter does not describe any specific performance criteria, testing, or studies, as it is solely focused on the regulatory clearance process.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria from the provided text.

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