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To create a percutaneous dilational tracheostomy using guidewire, pre-dilator, forceps and components of this product, which allows for tracheal access for airway management.

Portex Percutaneous Tracheostomy Kit

This document is a FDA 510(k) clearance letter for a medical device called the "Portex Percutaneous Tracheostomy Kit." It does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The letter primarily:

• Confirms a review of the premarket notification (510(k)).
• Determines substantial equivalence to a legally marketed predicate device.
• States that the device can be marketed subject to general controls and, if applicable, special controls.
• Outlines general responsibilities under the Federal Food, Drug, and Cosmetic Act.
• Includes an "Indications for Use" statement.

Therefore, I cannot provide the requested information about acceptance criteria or a study from the given text.

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