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The Manan™ VS Access Needle/Set is intended for the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.

The Manan™ VS Access Needle/Set is intended for the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study results related to the Manan™ VS Access Needle/Set. The document is a 510(k) summary for a medical device cleared in 1998, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study data against specific acceptance criteria.

The 510(k) summary states the following about the device:

• Device Name: Manan™ VS Access Needle/Set
• Intended Use: For the introduction of a .038" guidewire used in abscess, biliary, nephrostomy, and other fluid collection drainage procedures.
• Substantial Equivalence: To the Manan Medical Products V.S. Access Needle/Set (K963767).

To address your request, I would need a different type of document, such as a clinical study report, a validation study, or a more detailed technical file that outlines the device's performance characteristics and how they were evaluated against specific acceptance criteria.

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